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A COMPARATIVE STUDY OF THE ASSESSMENT OF TUBAL PATENCY IN FEMALE INFERTILITY BETWEEN MR HYSTEROSALPHINGOGRAPHY AND CONVENTIONAL HYSTEROSALPHINGOGRAPHY WITH DIAGNOSTIC LAPAROSCOPY AS GOLD STANDARDDissertation submitted to THE TAMILNADU Dr.M.G.R. MEDICAL UNIVERSITY In partial fulfillment of the requirements of M.D. DEGREE EXAMINATION BRANCH VIIIRADIODIAGNOSIS KILPAUK MEDICAL COLLEGE CHENNAI600 010 THE TAMILNADU DR. M.G.R. MEDICAL UNIVERSITY CHENNAI TAMILNADU, INDIA APRIL 2017
Transcript
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“A COMPARATIVE STUDY OF THE ASSESSMENT OF TUBAL

PATENCY IN FEMALE INFERTILITY BETWEEN

MR HYSTEROSALPHINGOGRAPHY AND CONVENTIONAL

HYSTEROSALPHINGOGRAPHY WITH DIAGNOSTIC

LAPAROSCOPY AS GOLD STANDARD”

Dissertation submitted to

THE TAMILNADU Dr.M.G.R. MEDICAL

UNIVERSITY

In partial fulfillment of the requirements

of

M.D. DEGREE EXAMINATION

BRANCH – VIII– RADIODIAGNOSIS

KILPAUK MEDICAL COLLEGE

CHENNAI– 600 010

THE TAMILNADU DR. M.G.R. MEDICAL UNIVERSITY

CHENNAI – TAMILNADU, INDIA

APRIL 2017

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BONAFIDE CERTIFICATE

This is to certify that the dissertation entitled “A COMPARATIVE

STUDY OF THE ASSESSMENT OF TUBAL PATENCY IN

FEMALE INFERTILITY BETWEEN MR

HYSTEROSALPHINGOGRAPHY AND CONVENTIONAL

HYSTEROSALPHINGOGRAPHY WITH DIAGNOSTIC

LAPAROSCOPY AS GOLD STANDARD” is a bonafide original work

of Dr.M.S Fouzal Hithaya under the guidance of Dr.J.Devimeenal M.D.,

Professor of department of Radio diagnosis, Govt. Kilpauk Medical

College & Hospital, Chennai -10 in partial fulfillment of the regulations

for M.D RADIO DIAGNOSIS BRANCH VIII examination of the

TamilNadu Dr. M.G.R Medical University to be held in april 2017.The period

of postgraduate study and training is from 2014 to 2017.

PROF.J.DEVIMEENAL,

DMRD., MD.,DNB

Guide

Professor & Head of Department,

Department of RadioDiagnosis,

Govt Kilpauk Medical college & Hospital,

Kilpauk, Chennai - 600 010.

Prof. Dr.R.NARAYANA BABU,

M.D,DCH,

Dean,

Govt Kilpauk Medical college &

Hospital,

Kilpauk,Chennai - 600 010.

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DECLARATION

I Dr.M.S.Fouzal Hithaya, solemnly declare that this

dissertation titled “A COMPARATIVE STUDY OF THE

ASSESSMENT OF TUBAL PATENCY IN FEMALE

INFERTILITY BETWEEN MR HYSTERSALPHINGOGRAPHY

AND CONVENTIONAL HYSTEROSALPHINGOGRAPHY WITH

DIAGNOSTIC LAPAROSCOPY AS GOLD STANDARD was

prepared by me at the Govt Kilpauk Medical College & Hospital,Chennai -

10, under the guidance and supervision of Dr. J.Devimeenal,Professor, Govt

Kilpauk Medical College &Hospital. This dissertation is submitted to The

Tamil Nadu Dr. M.G.R Medical University, towards partial fulfillment of

university regulations for the award of M.D branch VIII Radiodiagnosis.

Place: Chennai

Date: Dr.M.S Fouzal Hithaya

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ACKNOWLEDGEMENT

I express my heartful gratitude to the Dean,

Prof.Dr.R.NARAYANA BABU,M.D.,DCH Govt Kilpauk Medical

College & Hospital,Chennai-10 for permitting me to do this study.

I express my gratitude to Prof. Dr. J.DEVIMEENAL,

D.M.R.D., M.D., DNB., Head of the Department, Govt Kilpauk medical

college &Hospital, for her valuable guidance in doing the dissertation

work.

I owe a lot to Prof. Dr. J.DEVIMEENAL, D.M.R.D., M.D.,

DNB., who is also my guide whose expert guidance, constant

encouragement created an interest for me to pursue this study on MR

hysterosalphingography. It is her constant supervision and support that

made me possible to finish this study without much difficulty.

I am extremely thankful to my Professors,

Dr.P.CHIRTARARASAN, M.D., Dr. K.GOPINATHAN, M.D.,DNB.,

and Assistant professors Dr.R.KANAGASABAI, D.M.R.D., M.D.,

Dr.V.SUDHAKAR, M.D., Dr. G.USHA NANDHINI M.D.,DNB.,

DR.G.ARUN DILIP M.D., Dr.S.SUMEENA,DMRD., D.N.B,

Dr.D.PORKODI, DMRD., DR.S.SENTHILKUMAR DMRD., in the

Govt Kilpauk Medical College for their constant support,

encouragement and advice during my study.

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I am extremely thankful to Dr.T.K.SHANTHI GUNASINGH,

M.D., DGO., Prof. and HOD Department of Obstetrics and

Gynaecology, Kilpauk Medical College, for guiding and encouraging

me throughout the study.

I also thank my fellow postgraduates DR.P.PRASANNA and

DR. N.SUDHIR and junior postgraduates who helped me in carrying

out my work and preparing this dissertation.

I thank all Radiology technicians including Mr.VIJAY and

Mrs.GRACE MARY, Staff Nurses and all the Paramedical staff

members and workers including Mrs.JEYA in Department of

Radiology, for their co- operation in conducting the study.

I thank my husband Dr.BASHEER AHAMED, my parents

Mrs.& Mr. SYED MOHAMED, my sister HAMZA, daughter RIFA

SABURA for their understanding and co-operation in completion of

this work.

Last but not the least; I owe my sincere gratitude to the patients

and their relatives who co-operated for this study, without whom the

study could not have been possible.

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INDEX

Sl.No. CONTENTS PAGE

1 INTRODUCTION 1

2 AIMS AND OBJECTIVES 3

3 REVIEW OF LITERATURE 4

4 MATERIALS AND METHODS 36

5 CASES 42

6 STATISTICAL ANALYSIS AND RESULTS

RRESRESULTS

52

7 DISCUSSION 77

8 CONCLUSION 84

9 BIBLIOGRAPHY

ANNEXURE:

ABBREVIATIONS

ETHICAL COMMITTEE APPROVAL

PLAGIARISM

PROFORMA

CONSENT FORMS

MASTER CHART

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INTRODUCTION

The World Health Organization defines infertility as “ A disease of the

reproductive system defined by the failure to achieve a clinical pregnancy after

twelve months or more of regular unprotected sexual intercourse”(1). .

Secondary infertility is defined as the inability to become pregnant, or to carry

a pregnancy to term, following a previous pregnancy or the birth of one or

more biological children.

The global prevalence of primary infertility is about 2% and secondary

infertility is 3 %( 2). The factors attributed to infertility are divided into male

and female factors. The female factors are classified into ovarian, uterine, tubal

causes. Tubal factors are the commonest factors contributing to 30 – 40% of

the cases (3).

Hysterosalphingography is the radiographic technique used in the

evaluation of uterus, fallopian tubes. It is used as the first line of investigation

in the evaluation of tubal factors in infertility (4). Sonosalphingography is yet

another technique used in the evaluation of tubal patency.

Although these techniques are feasible enough they are not without

pitfalls which include limited evaluation of congenital abnormalities of

uterus and extra uterine pathologies. Further more conventional

hysterosalphingography carries an unavoidable risk of exposure of the female

reproductive organs to radiation in young and potentially fertile women.

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Most of the women undergoing conventional hystersalphingography

further require transabdominal and transvaginal ultrasound for further

anatomical details and identification of pathologies.

MRI of pelvis is the investigation of choice, because of its spatial and

contrast resolution in defining the anatomy as well as the pathologies of the

female reproductive tract as a whole. MRI well delineates the possible

abnormalities in the reproductive organs including congenital abnormalities,

myomas, endometriosis, ovarian cysts, polycystic ovaries etc.

MR hysterosalphingography (5) is a novel evolving technique that is

aimed at evaluating the tubal patency. Having the inherent advantage of

imaging the pelvis, MR hysterosalphingography is an innovative tool in female

infertility evaluation.

MR hysterosalphingography may be used as a single stop investigation

in detecting uterine, ovarian and tubal pathologies(6). There is no risk of

exposure of reproductive organs to radiation. MR hysterosalphingography as a

single investigation avoids the young women from undergoing a series of

varying investigations.

MR hysterosalphingography is a novel technique with very few pioneer

studies conducted at national as well as international levels. This prospective

study being done at Kilpauk Medical College is considered about the

introduction of this novel technique, designing the methodology of doing it,

and evaluating its diagnostic accuracy, thereby incorporating it in the infertility

evaluation protocol in the near future.

This study’s chief objective is to assess the feasibility and efficacy of

MR hysterosalphingography in identifying tubal patency in female infertility.

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AIM

To assess tubal patency in female fertility using dynamic MR

hysterosalphingography

OBJECTIVES

1. To assess the efficacy of dynamic MR hysterosalphingography in

identifying tubal patency in female infertility.

2. To directly compare the results of dynamic MR

hysterosalphingography with conventional hysterosalphingography

with diagnostic laparoscopy as gold standard.

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REVIEW OF LITERATURE

ANATOMY OF FEMALE REPRODUCTIVE SYSTEM

The female reproductive organs are divided into internal and external

organs. The internal organs include uterus with a pair of fallopian tubes and a

pair of ovaries (7).

The uterus is a hollow, firm, thick walled muscular organ. It is the child

bearing organ. It is situated in the pelvis, anteriorly is the urinary bladder and

posteriorly is the rectum. The adult uterus has the shape of an inverted pear. It

measures approximately 7.5 cm (superoinferior), 5cm (transverse), 2.5 cm

(antero posterior). It weighs about 30 – 40 grams.

PARTS OF THE UTERUS

The uterus has two parts: body and cervix. The body is the upper

expanded portion and forms upper two thirds whereas the cervix is the lower

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cylindrical portion which forms the lower one third of the organ. The

constriction situated between the body and cervix is called the isthmus.

POSITION OF UTERUS(8)

VERSION

Version is defined as the angle formed between the long axis of the

uterine body with the long axis of the vagina in sagittal plane. Normally the

uterus is anteverted and the angle of version is 90o and open forwards. When

the uterus is retroverted, the body of the uterus is tilted posteriorly.

FLEXION

Flexion is defined as the angle between the long axis of the uterus with

the cervix. Normally the uterus is anteflexed. The angle of anteflexion is 1250.

In retroflexed position, the uterus is flexed posteriorly. Normally the uterus is

anteverted and anteflexed such that the long axis of uterus corresponds to the

pelvic inlet and the long axis of vagina corresponds to the pelvic outlet.

Angle of anteversion

Angle of anteflexion

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BODY OF UTERUS: (9,10)

Body of the uterus has Fundus, anterior/ vesical surface, posterior/

intestinal surface and two lateral borders.

Fundus: Forms the convex dome of the uterus. It lies above the level of

openings for fallopian tubes.

Anterior surface: Flat and is related to the urinary bladder. Forms

posterior border of vesicouterine pouch.

Retroverted, Anteflexed

Retroverted, Retroflexed

Anteverted, Anteflexed

Anteverted, Retroflexed

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Posterior surface: Is convex and related to the bowel loops. Forms

anterior border of rectouterine pouch or Pouch of Douglas.

Lateral border: Rounded and convex. Gives attachment to the broad

ligament which attaches it to the lateral pelvic wall.

Uterine cavity: Uterine cavity is slit like and is compressed

anteroposteriorly. It is triangular in shape with base upwards and apex

downwards. At the superolateral angles the cavity becomes continuous with the

fallopian tubes on either sides through the cornua. At the apex the cavity

becomes continuous with the cervical canal through the internal os.

Layers of uterus

1. Endometrium: The inner mucosal layer is specialized for menstrual and

reproductive function

2. Myometrium: Muscular layer that forms the uterine volume. It is divided

into outer myometrium and inner myometrium. The inner myometrium is

called the junctional zone (11) and normally measures < 8mm. It is made up of

tightly packed compact smooth muscles with little amount of water content and

extra cellular matrix.

3. Perimetrium: Outer serosal layer.

CERVIX

Cervix is the lower cylindrical part of uterus. It measures approximately

2.5 cm in length. The lower part of cervix projects into the vagina which

divides the cervix into two parts:

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1. Supravaginal part

2. Vaginal part

Supravaginal part: Anteriorly related to the urinary bladder, separated

by parametrium made of fibrous tissue, posteriorly covered by the peritoneum

which reflects over the rectum forming the recto uterine pouch containing

small bowel loops, laterally extends the parametrium containing the ureters and

uterine arteries(12).

Vaginal part: The vaginal part projects anteriorly into the vagina.

Fornices are the spaces between the cervix and vaginal wall. There are anterior,

posterior and two lateral fornices.

Cervical canal: The cervical canal is fusiform in shape. It

communicates above with the uterine cavity through the internal os and below

opens into the vagina through the external os. The external os is bounded by

anterior and posterior lips. The walls have multiple mucosal folds called arbora

vitae uterine because they arborise like branches of a tree. These mucosal folds

interlock with each other so that the cavity is closed.

FALLOPIAN TUBES

Also called the uterine tubes. They are paired structures that extend

laterally from the cornua and open into the peritoneal cavity via the fimbrial

ends. The fallopian tube is 10 – 12 cm in length and 1 – 4 mm in diameter. It

bridges between ovaries laterally and uterus medially.

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PARTS

1. Interstitial / Intramural segment: situated within the myometrium.

2. Isthmus: lateral to it the isthmus which is the narrowest segment, about

2 – 3 cm in length.

3. Ampulla: widest part , about 4 mm in diameter, 6 – 7 cm in length

4. Infundibulum: funnel shaped lateral end of the tube which contains

multiple finger like processes called fimbriae. Ovarian fimbria is the one

which is the longest and is attached to the ovary.

OVARIES

A pair of female gonads, situated within ovarian fossa which lies in the

posterior wall of true pelvis. Each ovary is ovoid in shape and measures

approximately 1.5 x 3cm and weighs 2 – 8 grams. The central part is the

medulla and outer is the cortex. Ovarian follicles are situated within the stroma

of the ovarian cortex. The follicles are in varying stages of development and

degeneration.

BLOOD SUPPLY

UTERINE ARTERY

Arises from the anterior division of the internal iliac artery. It crosses the

ureter anteriorly and it traverses through the broad ligament and ends by

anastamosing with the ovarian artery.

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BRANCHES

Arcuate arteries to uterus: Arcuate arteries divide into radial arteries

which in turn penetrate the myometrium. At the endometrial level they divide

into basal and spiral arteries.

Tubal branch, Ovarian branch, Vaginal branch, Branch to round

ligament are the other branches.

OVARIAN ARTERY

Anterolateral branch from the abdominal aorta inferior to the level of

renal artery and superior to the level of inferior mesenteric artery. Supplies

ovary, fallopian tube and ends by anastamosing with ovarian branch of uterine

artery.

VENOUS DRAINAGE

Uterine veins drain into internal iliac veins.Right ovarian vein drains

into inferior vena cava. Left ovarian vein drains into left renal vein.

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NERVE SUPPLY

UTERUS: Supplied by branches from ovarian and hypogastric plexuses,

third and fourth sacral nerves.

OVARY: Ovarian plexus is formed by branches from aortic, renal,

superior hypogastric and inferior hypogastric plexuses.

SUPPORTS OF UTERUS (13)

BROAD LIGAMENT

Formed by two layers of the peritoneum that drape over the uterus and

extend to the lateral pelvic walls on either sides from the uterus.

Upper margin is formed by fallopian tubes medially and laterally is the

suspensory ligament of ovary. Lower margin ends in the cardinal ligament.

Between the leaves of broad ligament is parametrium which is formed by extra

peritoneal connective tissue and fat. Broad ligament encloses the round

ligament, ovarian ligament, ovarian and uterine blood vessels, nerves and

lymphatics.

ROUND LIGAMENT

Band of fibromuscular tissue extending from the anterolateral aspect of

uterine fundus takes a curved course, runs in inguinal canal to end in labia

majora.

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CARDINAL/ TRANSVERSE CERVICAL/ MACKENRODT’S

LIGAMENT

Extends from the cervix, upper vagina laterally to blend with fascia

covering obturator internus muscle. Its is the major supporting structure.

UTEROSACRAL LIGAMENT Extends posteriorly from the cervix and

vagina at the level of internal os and curves towards the anterior body of

sacrum at S2, 3 level.

OVARIAN LIGAMENT Extends laterally from the uterus to the ovaries.

SUSPENSORY LIGAMENT OF OVARY

Extends from anterolateral aspect of ovary and blends with fascia

covering psoas muscle.

Cross sectional image showing the relationship of uterine body, ovaries

with broad, round ligaments.

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EMBRYOLOGY OF UROGENITAL SYSTEM

The urogenital system is derived from the intermediate mesoderm(14,15)

from which develop the kidneys, gonads, reproductive and urinary tract.

Mesonephric or Wolffian duct develops and the ureteric bud branches from the

caudal end of Wolffian duct(16).Adjacent to the mesonephric duct develops the

paramesonephric duct or the Mullerian duct.

After sex determination the hormones – testosterone, anti mullerian

hormone(AMH), Insulin-like 3 (Insl3)(17) trigger the regression of Mullerian

duct and stimulate the development of male genital tract. In female fetus the

absence of these hormones stimulate the development of female reproductive

system from the Mullerian duct and the regression of the Wolffian duct.

From 6th to 11th week of gestation fusion of the paired Mullerian ducts

occur resulting in formation of uterus with cervix and also proximal 2/3rd of

the vagina. Bilateral fallopian tubes are formed from the unfused uppermost

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part of the paired Mullerian ducts. The central uterovaginal septum gets

absorbed by 9- 12 weeks, failure of which results in persistence of intrauterine

septum.

The ovaries are developed from the primitive yolk sac and lower 1/3 rd

of vagina is developed from the sinovaginal bulb which explains why these

anomalies are not commonly associated with Mullerian duct anomalies.

Widespread classification of Mullerian duct anomalies is given by

American Society of Reproductive Medicine (previously called as American

Fertility Society AFS ) in 1998 (18).

The European Society of Human Reproduction and Embryology

(ESHRE) (19) and European Society for Gynaecological Endoscopy improvised

the classification system.

Advantages of the new ESHRE/ ESGE classification:

Anatomy as the primary basis and embryology as the secondary

characteristic, user friendly, clear and accurate.

The prevalence of Mullerian duct anomalies is reported to be 0.16 – 10

% (20)

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AMERICAN FERTILITY SOCIETY CLASSIFICATION

CLASS TYPE

I – MULLERIAN

AGENESIS OR

HYPOPLASIA

A- Vaginal

B- Cervical

C- Fundal

D- Fallopian

E- Combined

II – UNICORNUATE

UTERUS

A – Communicating rudimentary

horn with endometrial cavity

B – Noncommunicating rudimentary

horn with endometrial cavity

C - Rudimentary horn without

endometrial cavity

D - No rudimentary horn

III – UTERUS DIDELPHYS

IV- BICORNUATE

UTERUS

A – Complete

B - Partial

V – SEPTATE UTERUS A – Complete

B - Partial

VI – ARCUATE UTERUS

VII – DIETHYL

STILBESTEROL RELAED

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ESHRE CLASSIFICATION

CLASS SUBCLASS

0 - NORMAL

I – DYSMORPHIC UTERUS a.T shaped

b.Infantile

II- SEPTATE UTERUS a.Partial

b.Complete

III – DYSFUSED UTERUS a.Partial

b.Complete

IV- UNILATERALLY FORMED a.Rudimentary horn with

cavity (Communicating/ Non

communicating)

b.Rudimentary horn without

cavity/ apalsia

V- APLASTIC/ DYSPALSTIC a.Rudimentary horn with

cavity (unilateral/ bilateral)

b. Rudimentary horn without

cavity (unilateral/ bilateral)/

aplasia

VI – UNCLASSIFIED

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CO EXISTENT SUBCLASS CERVICAL/ VAGINAL ANOMALY

Cervix:

C0 – Normal

C1 – Septate

C2 – Double normal

C3 – Unilateral aplasia/

Dysplasia

C4 – Aplasia/ Dyspalsia

Vagina:

V0 – Normal

V1 – Longitudinal nonobstructing septum

V2 – Longitudinal obstructing septum

V4 – Transverse septum/ imperforate hymen

V5 – Vaginal apalsia

INFERTILITY

Infertility is a major clinical problem affecting 10 – 15% of couples in

the reproductive age group. The tubal factors contribute to about 30 – 40 % of

the causes.

The tubal pathologies include blocked tubes, hydrosalphinx, tubo

ovarian mass.(21)

The ovarian pathologies include polycystic ovaries, ovarian cysts.

Endometriosis is yet another important cause of infertility.

EVALUATION OF INFERTILITY(22)

Recommended guidelines for practice in evaluation of infertility:

1. Confirmation of ovulation by S.Progesterone on Day 21 in a cycle of 28

days or 7 days prior to the presumed day of onset of menstruation.

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2. Hysterosalphingography to screen for uterine and tubal abnormalities

after excluding active pelvic infections and endometriosis.

3. Women with body mass index > 30 kg/m2 should be advised to loose

weight as it may restore ovulation.

4. Ovulation induction/ intrauterine insemination not to be offered in

women with unexplained infertility as it has not shown to increase

pregnancy rates.

Hysterosalphingography is the first line of investigation offered to

women to rule out uterine and tubal pathologies. As opposed to invasive

procedures like laparoscopy , hysterosalphingography is a minimally invasive

procedure with therapeutic effects also, hence considered prior to other

procedures.

The varying methods to assess tubal patency are complementary to each

other and any single method is not mutually exclusive.(23)

TUBAL FACTOR

It is an established fact that when a dominant follicle in the ovary grows

to maturity, there occurs a surge of Luteinizing hormone (LH). The LH surge

results in rupture of the follicle and release of the ovum. The ovary is covered

by the fimbrial end of the fallopian tube similar to a ball held in the palm (24).

Stephan et al (24) reported that the fimbriae get distended and the fimbrial

vessels get engorged and sweep gently. The pulsatile movements of the

fimbriae are synchronous with the heart beat of the patient and slowly pull the

released ovum into the fallopian tube.

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TECHNIQUES FOR ASSESSING TUBAL PATENCY

1. Conventional Hysterosalphingography

2. Sonohysterosalphingography

3. Magnetic Resonance Hysterosalphingography

4. Diagnostic laparoscopy

CONVENTIONAL HYSTEROSALPHINGOGRAPHY

Earlier called as Uterosalphingography, (25) was first introduced by

Heuser in 1924 in a paper titled, “The Clinical value of

Hysterosalphingography”. The paper was published in the third Pan American

Scientific Congress in Lima, Peru in December 1924. The contrast used at that

time was iodine in oil based solutions. In recent years the number of

hysterosalphingograms done have increased dramatically. This is attributed to

the advances made in assisted reproduction and advanced maternal age.(4)

TECHNIQUE (4)

No specific patient preparation is required prior to doing

hysterosalphingography. A nonsteroidal anti inflammatory drug is given one

hour prior to the procedure. The procedure is done between Day 7 – Day12 of

the menstrual cycle. The patient is advised to avoid sexual intercourse till the

day of procedure in the cycle. This is so as to avoid any minimal chance of

pregnancy. Moreover this is the period of proliferative phase during which the

endometrium is thinned out and this facilitates better interpretation of the

images. In patients with irregular menstrual cycles and suspicion of pregnancy,

beta hCG values are used in solving the mystery. Any risk of active pelvic

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inflammatory disease is to be avoided by checking the erythrocyte

sedimentation rate (ESR).

The patient is made to lie supine in lithotomy or modified lithotomy

position. A 5 - F HSG catheter is placed in the cervical canal and the balloon

is inflated fully.

A scout radiograph is taken prior to the contrast administration. Water

soluble contrast material is administered into the uterine cavity. Fluoroscopic

images are taken intermittently to visualize the uterus and fallopian tubes.

Four spot radiographs are taken. The first radiograph is taken during

early filling of the endometrial cavity, to visualize any filling defects. The

second radiograph is taken when the uterine cavity is fully distended with

contrast. The third image corresponds to the fallopian tubes. The fourth image

is to be taken to look for intraperitoneal spill if any. Oblique views are taken to

avoid superimposition if any. Final image is taken after deflating the balloon so

as to look for the lower uterine segment.

Raymond et al (26) states that the high clinical value of

hysterosalphingography is due to the fact that it gives almost a perfect mold of

the cavities of cervix, uterus and lumen of fallopian tubes. Moreover it also

gives a permanent record. Such intricate details cannot be even given by

varying other modalities like bimanual examination, dilatation and curettage,

hysteroscopy and laparotomy. Many lesions not clinically suspected are

identified in hysterosalphingography.

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a. Early filling, b. fully distended uterus, c. fallopian tubes showing interstitial,

isthmic, ampullary portions, d. intraperitoneal spill

Fallopian tubes in HSG

The fallopian tube appears as a 10 – 12cm long tubular structure

coursing along superior aspect of broad ligament. Radiographically three

segments are visible. The interstitial or cornual segment is short and traverses

the uterine musculature. The isthmic part is the longest and narrowest portion.

The ampullary part is the widest part near the ovary. The fimbriated portion is

the cone shaped end of fallopian tube and is not usually visualized in HSG.

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The major advantages of hysterosalphingography are

(i) To diagnose intracavitory lesions

(ii) Fallopian tubal block and hydrosalphinx

(iii) Therapeutic effect of opening a blocked tube which is evidenced by

previously infertile women becoming pregnant after the procedure.

The major contraindications are:

(i) Active infection

(ii) Pregnancy

The major complications are:

(i) Minimal spotting lasting for less than 24 hours

(ii) Introduction of intrauterine infection. The risk of infection can be

prevented by the strict usage of sterile instruments and aseptic technique

(iii) Cramping pain. The pain is most severe during the time of inflation of

balloon in case of intrauterine catheter, and also when the uterine cavity

is distended with contrast material.The cramping pain is usually minimal

and transient and well tolerated by most of the patients

The other potential but rare complications include:

(i) Severe pain resulting in premature termination of the procedure due

to vasovagal reaction.

(ii) Systemic reaction to the contrast material if vascular intravasation

occurs, but lymphatic and vascular intravasation are supposed to be

clinically insignificant and not dangerous.

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(iii) Perforation of uterus which is extremely rare and can be avoided by

skilled technique.

(iv) Risk of radiation exposure to the reproductive organs.

(v) Radiation exposure to an early unsuspected pregnancy, but it can be

avoided by proper timing of the examination and a negative

pregnancy test.

CONTRAST MEDIA

The use of oil based iodine solutions has multiple complications (27)

including edema of the fallopian tubes, and when spilled into the uterine cavity

cause adhesions with the adjacent organs. The use of oil based solutions has

become obsolete and now replaced by the use of water soluble contrast

media(28).

Boer et al (29) compared the pregnancy rate and quality of images in a

randomized control study in hysterosalphingography done using oil contrast

media and aqueous contrast media.

The oil contrast media used was Ethiodol, a mixture of fatty acids

obtained from poppy seeds. The aqueous contrast media used was a non ionic

low osmolar contrast media Iopamidol.

The oil contrast media provided a sharper image with more contrasting

image. The outline of uterine cavity was better delineated with oil contrast

media. However the ampullary folds were better defined using aqueous

contrast media. This is explained due to the lower iodine concentration in water

soluble media (30).

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The water soluble media got dispersed in the peritoneal cavity within

10minutes which enables the control picture to be taken within 15 minutes. The

oil contrast media was reabsorbed from the peritoneal cavity only after two

hours which may persist even longer giving the chance of granuloma formation

and foreign body reaction within the peritoneal cavity.

There was no statistical difference in pregnancy rates following the two

procedures as against the increased pregnancy rate following oil based media in

studies conducted by Mackey et al and DeCherney et al (31, 32,33)

However Lindequist et al (34) and Rasmussen et al (35) reported that pain

during HSG after oil or water based media is the same but water based media

have increased rate of post procedure bleeding and infection.

Spring et al (36) in their prospective control study concluded no

significant difference in pregnancy rates following the use of varying contrast

media.

A well known complication of HSG is vascular or lymphatic

intravasation of contrast media. The incidence is reported to be about 6%. Use

of oil based contrast media can hence result in oil emboli ending up with

serious cardiovascular complications.

Notifying the risks and benefits water soluble contrast media is

considered preferable for HSG in day to day clinical practice.

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CONTRAST INTRAVASATION

Intravasation (37) indicates the backward flow of the contrast media into

the adjoining veins. The contrast media passes from the endometrial cavity via

the myometrial veins into the draining pelvic veins, ovarian veins in particular.

The factors predominantly causing intravasation are the conditions

increasing endometrial vascularity and permeability. Few clinical examples

include menometorrhagia, endometriosis, urinary tract infections, and previous

history of uterine surgery. It is also noted to be seen with increased intrauterine

pressure because of tubal obstruction. Catheter cannulation and fixation

causing pain and discomfort to the patient may induce spasm and trauma

resulting in intravasation. The prevalence of intravasation is about 0.4 –

6.9%.Intravasation is classified into four levels (38) as follows:

1. Level 0: No intravasation

2. Level I: Minimal intravasation limited to myometrium

3. Level II: Moderate but slow intravasation into parametrial, adnexal

veins

4. Level III: Severe instant intravasation from myometrial, parametrial

veins into paracaval veins

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Level I – Intravasation showing myometrial enhancement (m)

Level II – Opacification of myometrial veins extending to iliac veins

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Level III intravasation – Bilateral tubal spill with instant intravasation

into pelvic veins

Intravasation is now of less clinical significance (39) with the use of

water soluble contrast media. Nevertheless the reporting radiologist must be

confident enough to differentiate it from intraperitoneal spill in tubal blockage.

Eliminating the predisposing factors and proper timing of the procedure and

technique can eliminate the intravasation.

CATHETER TYPE

There are multiple studies comparing the utility of balloon catheter vs

metallic cannula in performing hysterosalphingography.

Tur – Kaspa et al (40) in a prospective, blinded, randomised control study

compared the utility of balloon catheter vs metallic cannula in terms of pain,

time of the procedure.

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The procedure using balloon catheter was statistically significant by

using lesser contrast media, lesser procedure time, less pain and discomfort to

the patient. However the quality of images were same with both the techniques.

The balloon catheter provides better seal at the level of internal os

thereby preventing reflux of contrast, faster and better visualisation of uterine

cavity, fallopian tubes. The increased intensity of pain with metallic cannula is

explained due to the tension applied by it on the cervix.

Mello et al(41) described in a prospective study that the intensity of pain

using balloon catheter, metallic cannula with paracervical block was

significantly less when compared to the traditional method of using metallic

cannula without any anaesthesia.

Shlomo et al (42) in a prospective study described that cervical vacuum

cup cannula causes significantly less pain, lesser procedure time, smaller

amount of contrast when compared with traditional metallic cannula.

Ubeda et al (43) described that introduction of air bubbles incidentally

may be mistaken for filling defects, polyps but identified by the fact that they

are well defined, mobile and can be flushed out of the tubes by further injection

of contrast. However introduction of air bubbles can be effectively prevented

by removing the air trapped within the cannula.

Moro et al(44) in a randomised controlled double blinded study evaluated

the effectiveness of antispasmodic drug hyoscine – N – butylbromide in

contrast enhanced sonohysterosalphingography. There was no statistical

difference in pain score between the hyoscine group and placebo group.

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Aytekim et al (45) evaluated the effect of preprocedure anxiety on post

procedure pain scales and HSG outcomes. They identified that there was a

statistical significance in increase in pain intensity in patients with increased

preprocedure anxiety. But there was no statistical difference in tubal patency

between the two groups with lower and higher anxiety levels.

Maryam et al(46) evaluated the effect of anti axiety drug valerium in a

test group as against placebo group and identified significant reduction in post

procedure anxiety score in the test group.

ANTIBIOTIC PROPHYLAXIS

The 31st Royal College of Obstetricians and Gynaecologists Study

Group on the Prevention of Pelvic Infection recommended the use of following

antibiotics(47) after an intrauterine instrumentation procedure like

hysterosalphingography if not previously screened for Chlamydia.

Doxycycline 100 mg orally, twice daily for a week, Ofloxacin 400 mg

orally twice daily with Clindamycin 450 mg orally four times daily or

Metronidazole 500 mg orally twice daily, for a week.

DIAGNOSTIC ACCURACY OF HSG

According to Egle et al (48) the sensitivity and specificity of HSG in

identifying bilateral tubal occlusion is 89.5% and 90% respectively.

Adrian et al (49) followed up HSG results with laparoscopy,

hysteroscopy, fertility outcomes according to which HSG had false positivity

of 39%, and negative predictive value of 100%.

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Bukar et al (50) in a retrospective study reviewed HSG images and

identified tubal pathologies in about 72% of the cases.

Chou et al (51) questioned the utility of HSG as the first line investigation

in female infertility stating the sensitivity and specificity as 53% and 85% and

introduced a new technique of Chlamydial antibody detection with similar

reliability as HSG and hence can replace it.

Vahdat et al (52) in a study evaluated that HSG had a sensitivity of

95.6%, specificity of 60%, PPV of 84.62%, and NPV of 85.71% in diagnosing

uterine malformations.

MRI PELVIS IN INFERTILITY

Though HSG is the mainstay and the initial imaging modality in

infertility evaluation, MRI is a useful adjunct since its introduction. MRI pelvis

because of its excellent tissue contrast helps in delineating pelvic anatomy and

pathologies as well in a detailed and descriptive way.

The commonly encountered pathologies in infertility(53) include (i)

congenital uterine anomalies, (ii) acquired uterine abnormlaities like fibroids,

(iii) extrauterine pathologies like adnexal cysts, endometriosis.

The sequences routinely used include (53) coronal T1 (TR 400-500ms, TE

20ms, slice thickness 10mm, gap 2mm, one acquisition), axial, sagittal, oblique

coronal T2 (TR 2000 – 2,500MS, TE 30 – 70ms, 3-5mm slice thickness,

0.5mm gap, FOV 28 -36CM, 256 pixels ) MRI depicts congenital uterine

abnormalities in a detailed manner including the features about cavity, septum,

external contour.

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Uterus didelphys has widely separated uterine horns (intercornual

distance > 4cm) and two separate endometrial cavities, cervices, upper vagina

A fundal cleft > 1cm(54)is reported to be 100% sensitive and specific in

differentiating fusion anomalies (didelphys and bicornuate) from reabsorption

anomalies (septate and arcuate).

When the apex of the fundal contour is below or less than 5 mm above

a line drawn between the tubal ostia, the uterus is bicornuate. When the apex of

the fundal contour is more than 5 mm above a line drawn between the tubal

ostia, the uterus is septate.

The correct classification of Mullerian ductal anomalies is critical in

deciding on further surgical management which is achieved by MRI as it gives

better details about external uterine contour, endometrial, myometrial width

which is not provided by HSG (55).

Normal

Uterus didelphys

Bicornuate

Septate

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MR HYSTEROSALPHINGOGRAPHY

The first MR hysterosalphingography trial dates back to 1996 when

Fred et al (56) evaluated its efficacy in 18 rabbit uterine horns. Five of the

fallopian tubes were ligated and 11 were left unaltered. 1 – 3ml of diluted

gadolinium contrast was injected via transvaginal catheter and T1 weighted

gradient images were taken before, during and after injection of contrast. It was

followed by conventional imaging with equal amount of iohexol and evaluation

was done by two radiologists blinded to the other study. Conventional HSG

correctly identified spill in all 11 cases and absence in all 5 cases. MRHSG

showed concurrent results in 14 of the 16 cases. Sensitivity and specificity of

MRHSG were 95.5% and 70% for tubal block. There was no statistical

difference between conventional HSG and MRHSG results.

Frye et al(57) in 2000 did a feasiblity study with a phantom simulating

uterus, fallopian tubes and surronding pelvic cavity. Container measuring 40 x

25 x 10cm was used to simulate uterus. The fallopian tube was 40cm long and

1mm inner diameter. The observations of the study were (i) the choice of

sequence was half Fourier RARE sequence which provide adequate temporal

resolution. (ii)The opitmal contrast agent was distilled water and (iii)quantity

was 5ml.

Weisner et al (58) in 2001 published a preliminary report on MRHSG

with a small sample size of 5. The sequences used were T1 SE, T2FSE and

angiographic sequences for 3D dynamic MRHSG. They concluded that

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MRHSG is a feasible technique and further research is required to consider it

as an alternative technique to conventional HSG.

Sadowski et al (5) in 2008 did a prospective study on MRHSG using

dynamic time resolved T1weighted angiographic sequence - 3D TRICKS

using 2 sets of 1: 100 diluted gadodiamide in a sample size of 17 all of which

were preceeded by conventional HSG. The procedure could not be completed

in 1 patient. In 16 patients both MR and conventional HSG concurrently

showed bilateral block. Six tubes blocked on conventional HSG were patent on

MRHSG. Increased patency was thought to be due to the tubal block opened by

conventional HSG done prior to it. The increased sensitivity of MR to even

small amount of contrast was the other explanation given.

James (59) countered the Sadowsiki’s study in 2009 arguing that the

increased patency of MRHSG was not due to increased sensitivity of MRI but

rather due to the use plastic catheter instead of metallic cannula and its better

palcement yielded better tubal opacification.

Unterweger in 2002 (6) aimed at direct visualisation of fallopian tubes in

addition to patency by use of a specific higher viscosity contrast solution –

gadolinium mixed with polyvidone gel and compared the results with

conventional HSG in a sample size of 10. The direct visualisation of fallopian

tubes was possible in 5 cases. Eight out ot the 10 cases - six cases with bilateral

patency and 2 patients with unilateral block were concurrent with conventional

HSG results.

Winter et al (60) in 2010 tried a similar study in 37 patients using

Dotarem polyvidone in 1: 20 ratio. The procedure was abandoned in four of 37

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patients due to dislodgement of catheter. 27 patients showed bilateral tubal

patency which was confirmed by laparoscopy.

De Feliche et al (61) considered MRHSG as a new promising tool in

infertility imaging and conducted a study with 16 patients to evaluate the

efficacy of MRHSG and to improvise the techniques. The average time period

was 25 – 30 minutes. 12/ 16 cases showed bilateral tubal patency .

Ma et al (62) conducted a MRHSG study with 20 infertile women and

compared it with previous HSG or laparoscopy results. Except for one case

with blocked tube in conventional HSG, MRHSG showed patency, the other

results were concurrent.

Cipolla et al (63) in 2016 did a study with 116 patients on 3T using time

resolved 3D sequence. Results were patency in 65%, unilateral block in 25%

and bilateral block in 9.8% and suggested MR with MRHSG as a single stop

shop investigation in infertility imaging.

DIAGNOSTIC LAPARSCOPY

Tshabu et al (64) did a comparative study of HSG with laparoscopy. The

concardance between the two in tubal block was about 47%. Only 5.2% of the

tubes patent at HSG were blocked in laparoscopy. The conclusions of the study

were that HSG is complementary to laparoscopy in infertility evaluation. HSG

has better reliability in diagnosing tubal patency than detecting tubal block.

Laparoscopy reveals out falsely blocked tubes at HSG and in addition picks up

endometriosis and pelvic adhesions.

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Fatemeh et al (65) did a comparative prospective study on HSG followed

by laparoscopy as gold standard after an interval of 3 months. The sensitivity,

specificity, positive, negative predictive values, accuracy were 92.1%, 85.7%,

97.2%, 66.7%, 99.1% respectively.

Tsuji et al (66)evaluated the utility of diagnostic laparoscopy in patients

with normal hysterosalphingography findings. The study consisted of 54

patients. Laparscopy revealed pathologic findings in nearly 80% of the patients.

So the study concluded that diagnostic laparscopy is mandatory in all infertile

patients with normal hysterosalphingography prior to artificial reprouctive

techniques because of its proven diagnostic and therapeutic benefits.

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MATERIALS AND METHODS

At our institution female patients presenting with infertility are

evaluated in Department of Obstetrics and Gynecology and then referred

to Department of Radio diagnosis for radiological evaluation.

Forty patients between age 20 – 40 yrs with primary or secondary

infertility were referred for evaluation of tubal patency. The patients were

first subjected to dynamic MR hysterosalphingography and subsequently

to conventional hysterosalphingography. Those with tubal block were

subjected to diagnostic laparoscopy as a part of further evaluation and to

confirm the tubal block.

The study was conducted after obtaining proper informed consent

from the patient. As this was a prospective controlled study, ethical

committee approval from Institutional Ethics Committee, Kilpauk

Medical College, was obtained.

INCLUSION CRITERIA

1. Age group : 20 – 40 yrs

2. Patients with primary infertility with failure to achieve a clinical

pregnancy after 12 months of unprotected sexual intercourse.

3. Patients with secondary infertility with failure to achieve a clinical

pregnancy after 12 months of unprotected sexual intercourse.

4. Postoperative evaluation of patients following reversal of tubal

ligation.

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5. Recurrent spontaneous abortions

6. Day 7 – Day 12 of menstrual cycle (4)

EXCLUSION CRITERIA:

1. Menstruating females

2. Beyond Day 12 of menstrual cycle.(4)

3. Non consenting and unco-operative patients

4. Patients with active pelvic inflammatory disease

5. Patients with contraindications to MRI - pacemaker and cochlear

implants

STUDY DESIGN:

All the patients were advised to abstain from sexual intercourse

during the days after menstruation till the day of procedure so as to avoid

any chance of pregnancy during the procedure.

The procedure was commenced after obtaining informed consent

from the patient with detailed explanation of the procedure to be

undertaken. The patient was given oral mefanamic acid (65) three times a

day and a course of antibiotics (combination of ofloxacin and

metronidazole) as premedication starting on the day before and

continued two days post procedure.

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The patient was asked to empty the bladder and made to lie in

lithotomy or modified lithotomy position in the lithotomy table. The

external genitalia was painted with povidone – iodine solution and draped

with sterile towels. Per vaginal examination was done to assess the

version, size of uterus.

Sim’s speculum was inserted into the vagina. The cervix was

cleansed with povidone – iodine gauze. The anterior lip of cervix was

held gently with a valsellum forceps. Uterine sound was inserted into the

uterine cavity to assess the length of the uterine cavity.

MRI compatible plastic Hysterosalphingogram 5 - F micro catheter

with inflatable bulb was inserted into the lower uterine cavity. The bulb

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was inflated with 3 cc of distilled water. The guide wire was removed and

an empty 3ml syringe attached to the catheter. The speculum and

valsellum forceps were removed.

The patient was then shifted to MRI scan. 1.5 Tesla (GE) machine

was used. The following sequences were used:

1. T2 W Axial

TR: 7120 ms,

TE: 90 ms,

Flip angle 900

Slice thickness 5mm,

Matrix 256 x 256

2. T2W Coronal

3. T2 W Sagittal

4. T1 W Axial

TR: 740 ms,

TE: 13 ms,

Flip angle 900

Slice thickness 5mm,

Matrix 256 x 256

5. T1 Cube Coronal – 5 phases each phase scanning for 15 seconds..

TR: 3.8 ms,

TE: 1.8 ms,

TI: 7ms,

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Flip angle 120

Slice thickness 3.4 mm,

Matrix 256 x 256

The first phase was imaged prior to saline infusion. 10 ml of 1 in

100 dilution of Gadodiamide (Omniscan GE Healthcare 0.5mmol/ml) in

0.9% saline was instilled and the successive phases were obtained.

4 successive phases were obtained demonstrating the endometrial

cavity, tubal patency/ block, peritoneal spill if any. Corresponding

subtracted images were generated automatically.

The patient was immediately mobilized to the Xray room. 10 ml of

iodinated contrast iohexol (Omnipaque GE Healthcare 350mg/ml)

instilled through the same catheter. Spot film was taken to look for

endometrial cavity, fallopian tubes, peritoneal spill if any. The balloon

was deflated and the catheter removed.

The patients with unilateral or bilateral tubal block were subjected

to diagnostic laparoscopy in their next cycle as a part of routine

subsequent evaluation and the findings were confirmed at the same time.

The patients with bilateral tubal patency were followed up after 3

months and if failed to conceive were subjected to diagnostic laparoscopy

as a part of further evaluation at department of Obstetrics and

Gynecology, KMC and the findings were confirmed during the

procedure.

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Diagnostic laparoscopy was done in the Department of Obstetrics

and Gynecology by gynecologist. Methylene blue dye was used for

assessing the tubal patency. Direct visualization of spill into the

peritoneal cavity was done with laparoscope.

The results were tabulated. Statistical analysis was made

comparing the results of MRHSG, conventional HSG with diagnostic

laparoscopy as gold standard.

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CASE : 1

30yrs old, P2L1, tubectomy done 5years back, post tubal reanastamosis status

Coronal T2W with balloon

catheter placed in situ just

beyond the level of internal

os

Coronal T1 CUBE Phase 1

image prior to the

instillation of 1: 100

gadodiamide in saline

Coronal T1CUBE Phase 2

image showing contrast

within the endometrial

cavity, absence of peritoneal

spill on both sides, reflux of

contrast in the vagina

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Conventional HSG showing

uterine cavity, bilateral tubal

block

Subtracted images reformatted

showing contrast within

endometrial cavity and absence

of peritoneal spill, reflux of

contrast in the vagina

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CASE: 2

31 years nullipara with previous history of two spontaneous first trimester

abortions

Axial and Sagittal T2W images showing balloon catheter

within the endometrial cavity

Coronal T1 CUBE Phase 2

image showing contrast

within uterine cavity and

bilateral fallopian tubes

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Coronal T1 CUBE Phase 3

image showing contrast

within uterine cavity and

bilateral peritoneal spill

Subtracted images

reformatted showing

contrast within endometrial

cavity and bilateral

peritoneal spill

Conventional HSG showing

uterine cavity, bilateral

peritoneal spill

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CASE : 3

24 years old, nullipara with previous history of two spontaneous first trimester

abortions

Axial T2 W images showing two uterine horns uniting at the level of internal

os with a single cervix. The external uterine contour is convex without

indentation – partial septate uterus. The cervix is deflected to the left.

Longitudinal vaginal septum

pulled out for better

visualisation

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TI CUBE Phase 3 image

showing absence of

peritoneal spill on both

sides.

Conventional HSG

showing two uterine

horns, right fallopian tube

and right peritoneal spill

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CASE : 4

24years nulligravida, married for 2 years

Axial T1, Coronal T2 W images showing balloon catheter within the

endometrial cavity with left ovarian cyst with areas of T1, T2

hyperintensities suggestive of haemorrhagic cysts

Subtracted reformatted image

showing bilateral tubal block

where as conventional HSG shows

right tubal spill and Type III

intravasation of contrast

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CASE :5

35 yrs P1L1, last child birth 10years back for secondary infertility evaluation

Axial and Sagittal T2W images showing T2 hyperintense oblong

cystic lesion in right adnexa with few internal septations

mimicking right hydrosalphinx

Coronal T1 CUBE images Phase 2 showing left tube and

Phase 3 showing right tube and absence of peritoneal spill

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Subtracted reformatted

images showing bilateral

tubes and distal block and no

peritoneal spill, refluxed

contrast in the vagina

Conventional HSG showing

bilateral fimbrial block and

no peritoneal spill

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CASE :6

25 years P2L1, post tubal reanastamosis status

Coronal T2 W image with

balloon catheter in situ

Subtracted reformatted

image showing uterine

cavity

Subtracted reformatted image showing left tubal spill,

corresponding conventional image showing left tubal spill

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STATISTICAL ANALYSIS AND RESULTS

TYPE OF INFERTILITY

TYPE OF INFERTILITY NO. OF CASES

PRIMARY 22

SECONDARY 18

TYPE OF SECONDARY INFERTILITY

CAUSES OF SECONDARY INFERTILITY NO. OF CASES

RECURRENT ABORTIONS 4

POST TUBAL REANASTAMOSIS 9

UNEXPLAINED 5

TYPE OF

OCCLUSION

NO. OF CASES

PROXIMAL 14

DISTAL 2

TOTAL 16

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TYPE OF

INFERTILITY

MR HSG BLOCK

PATENT

TOTAL UNILATERAL BILATERAL

PRIMARY

0

5

17

22

SECONDARY

3

8

7

18

TOTAL

3

13

24

40

PRIMARY56%

SECONDARY -ABORTIONS

10%

SECONDARY -PTRA22%

SECONDARY -UNEXPLAINED

12%

INFERTILITY

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TYPE OF

INFERTILITY

CONVENTIONAL HSG

BLOCK

PATENT

TOTAL

UNILATERAL BILATERAL

PRIMARY

1

4

17

22

SECONDARY

3

8

7

18

TOTAL

4

12

24

40

TYPE OF HSG

BLOCK

PATENT

TOTAL UNILATERAL BILATERAL

MR HSG

3

13

24

40

CONVENTIONAL

HSG

4

12

24

40

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TYPE OF

HSG

BLOCK PATENT TOTAL

UNILATERAL BILATERAL

MR HSG

3

13

24

40

DL

7

9

24

40

TYPE OF HSG TUBES

BLOCKED

TUBES

PATENT

TOTAL

MRHSG 29 51 80

CONVENTIONAL HSG 28 52 80

DIAGNOSTIC

LAPAROSCOPY

25 55 80

NON TUBAL PATHOLOGIES NUMBER

UTERINE ANOMALIES 4

MYOMA UTERUS 2

POLYCYSTIC OVARIES 6

OVARIAN CYSTS 3

ENDOCERVICAL POLYP 1

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POST TUBAL REANASTAMOSIS TUBAL STATUS

PATENT

U/L BLOCK

B/L BLOCK

0

1

2

3

4

5

6

7

8

PRIMARY INFERTILITY

SECONDARY INFERTILITY

PATENT

U/L BLOCK

B/L BLOCK

B/LBLOCK56%U/L BLOCK

22%

PATENT22%

0%

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RIGHT TUBE: MR HSG - AGE GROUP

Crosstab

MR HSG RIGHT

PATENT BLOCK Total

AGE

GROUP

21-25 YEARS Count 11 4 15

% within MR HSG

RIGHT

42.3% 28.6% 37.5%

% of Total 27.5% 10.0% 37.5%

26-30 YEARS Count 7 5 12

% within MR HSG

RIGHT

26.9% 35.7% 30.0%

% of Total 17.5% 12.5% 30.0%

31 YEARS &

ABOVE

Count 8 5 13

% within MR HSG

RIGHT

30.8% 35.7% 32.5%

% of Total 20.0% 12.5% 32.5%

Total Count 26 14 40

% within MR HSG

RIGHT

100.0% 100.0% 100.0

%

% of Total 65.0% 35.0% 100.0

%

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LEFT TUBE MRHSG AGE GROUP Crosstab

MR HSG LEFT

PRESENT BLOCK Total

AGE GROUP 21-25 YEARS Count 10 5 15

% within MR HSG LEFT 40.0% 33.3% 37.5%

% of Total 25.0% 12.5% 37.5%

26-30 YEARS Count 8 4 12

% within MR HSG LEFT 32.0% 26.7% 30.0%

% of Total 20.0% 10.0% 30.0%

31 YEARS & ABOVE Count 7 6 13

% within MR HSG LEFT 28.0% 40.0% 32.5%

% of Total 17.5% 15.0% 32.5%

Total Count 25 15 40

% within MR HSG LEFT 100.0% 100.0% 100.0%

% of Total 62.5% 37.5% 100.0%

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RIGHT TUBE: MR HSG – YEARS AFTER MARRIAGE

Crosstab

MR HSG

RIGHT

PATE

NT

BLOC

K Total

MARITAL

HISTORY

GROUP

0-5

YEARS

Count 18 5 23

% within MR HSG

RIGHT

69.2% 35.7% 57.5%

% of Total 45.0% 12.5% 57.5%

6-10

YEARS

Count 4 6 10

% within MR HSG

RIGHT

15.4% 42.9% 25.0%

% of Total 10.0% 15.0% 25.0%

11-15

YEARS

Count 4 3 7

% within MR HSG

RIGHT

15.4% 21.4% 17.5%

% of Total 10.0% 7.5% 17.5%

Total Count 26 14 40

% within MR HSG

RIGHT

100.0% 100.0% 100.0%

% of Total 65.0% 35.0% 100.0%

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LEFT TUBE: MR HSG – YEARS AFTER MARRIAGE

Crosstab

MR HSG LEFT

PATEN

T

BLOC

K Total

MARITAL

HISTORY GROUP

0-5

YEARS

Count 18 5 23

% within MR

HSG LEFT

72.0% 33.3% 57.5%

% of Total 45.0% 12.5% 57.5%

6-10

YEARS

Count 4 6 10

% within MR

HSG LEFT

16.0% 40.0% 25.0%

% of Total 10.0% 15.0% 25.0%

11-15

YEARS

Count 3 4 7

% within MR

HSG LEFT

12.0% 26.7% 17.5%

% of Total 7.5% 10.0% 17.5%

Total Count 25 15 40

% within MR

HSG LEFT

100.0% 100.0% 100.0%

% of Total 62.5% 37.5% 100.0%

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RIGHT TUBE: MR HSG - POST TUBAL REANASTAMOSIS

Crosstab

MR HSG RIGHT

PATENT BLOCK Total

PTRA NO Count 23 8 31

% within MR HSG

RIGHT

88.5% 57.1% 77.5%

% of Total 57.5% 20.0% 77.5%

YES Count 3 6 9

% within MR HSG

RIGHT

11.5% 42.9% 22.5%

% of Total 7.5% 15.0% 22.5%

Total Count 26 14 40

% within MR HSG

RIGHT

100.0% 100.0% 100.0%

% of Total 65.0% 35.0% 100.0%

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LEFT TUBE: MR HSG - POST TUBAL REANASTAMOSIS

Crosstab

MR HSG LEFT

PATENT BLOCK Total

PTRA NO Count 22 9 31

% within MR HSG

LEFT

88.0% 60.0% 77.5%

% of Total 55.0% 22.5% 77.5%

YES Count 3 6 9

% within MR HSG

LEFT

12.0% 40.0% 22.5%

% of Total 7.5% 15.0% 22.5%

Total Count 25 15 40

% within MR HSG

LEFT

100.0% 100.0% 100.0%

% of Total 62.5% 37.5% 100.0%

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Right Tube: MRHSG Vs Xray HSG

MRHSG

XrayHSG

Positive

Negative

Total

Positive

13 1 14

Negative

0 26 26

Total

13 27 40

Parameter

Estimate (95% CI –

Wilson score)

Sensitivity

100%

Specificity

96.3%

PPV

92.86%

NPV

100%

Diagnostic

accuracy

97.5%

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Left Tube: MRHSG Vs Xray HSG

Statistical test Value right Value left

McNemar 1.0 1.0

Kappa agreement 0.94 1.0

XrayHSG

MRHSG Positive Negative Total

Positive 15 0 15

Negative 0 25 25

Total 15 25 40

Parameter Estimate (95% CI – Wilson

score)

Sensitivity 100%

Specificity 100%

PPV 100%

NPV 100%

Diagnostic accuracy 100%

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Right tube: MRHSG Vs DL

MRHSG

DL

Positive Negative Total

Positive

12 2 14

Negative

0 26 26

Total

12 28 40

Parameter

Estimate (95% CI – Wilson score)

Sensitivity

100%

Specificity

92.86%

PPV

85.71%

NPV

100%

Diagnostic accuracy

95%

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Left tube: MRHSG Vs DL

MRHSG

DL

Positive Negative Total

Positive

13 2 15

Negative

0 25 25

Total

13 27 40

Parameter Estimate (95% CI – Wilson score)

Sensitivity 100%

Specificity 92.59%

PPV 86.67%

NPV 100%

Diagnostic accuracy 95%

Statistical test Value right Value left

McNemar 0.5 0.5

Kappa agreement 0.88 0.88

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Right tube: XrayHSG Vs DL

XrayHSG

DL

Positive Negative Total

Positive

12 1 13

Negative

0 27 27

Total

12 28 40

Parameter

Estimate (95% CI – Wilson score)

Sensitivity

100%

Specificity

96.43%

PPV

92.31%

NPV

100%

Diagnostic accuracy

97.5%

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Left tube: X-rayHSG Vs DL

XrayHSG

DL

Positive Negative Total

Positive

13 2 15

Negative

0 25 25

Total

13 27 40

Parameter Estimate (95% CI – Wilson score)

Sensitivity 100%

Specificity 92.59%

PPV 86.67%

NPV 100%

Diagnostic accuracy 95%

Statistical test Value right Value left

McNemar 1.0 0.5

Kappa agreement 0.94 0.89

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Bilateral tubes: MRHSG Vs XrayHSG

MRHSG

XrayHSG

Positive Negative Total

Positive

28 1 29

Negative

0 51 51

Total

28 52 80

Parameter

Estimate (95% CI – Wilson score)

Sensitivity

100%

Specificity

98.08%

PPV

96.55%

NPV

100%

Diagnostic accuracy

98.7.5%

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Bilateral tubes: MRHSG Vs DL

MRHSG

DL

Positive Negative Total

Positive

25 4 29

Negative

0 51 51

Total

25 55 80

Parameter Estimate (95% CI – Wilson score)

Sensitivity 100%

Specificity 92.73%

PPV 86.21%

NPV 100%

Diagnostic accuracy 95%

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DISCUSSION

The study comprised of 40 patients with either primary or secondary

infertility referred from the department of Obstetrics and Gynecology for

hysterosalphingography. The study included women from 20 – 40 years. The

mean age of the patients was 24.8 years.

The study was completed in all 40 patients with good patient compliance

as against the previous studies in which it was abandoned in 1 out of 17

patients in study conducted by Sadowski et al(5) 4 out of 37 patients in study

conducted by Winter et al (60)

The patients with primary infertility were 22 in number constituting

56% of the sample size. The patients with secondary infertility were 18 in

number constituting 44% of the sample size. According to Tshabu et al (64), in

their study primary infertility was 66.3% and secondary infertility was 33.7%

of cases.

Among the patients with secondary infertility 4 patients (10%) had

previous history of recurrent abortions. 9 patients (22%) had history of

tubectomy and surgery done for reversal of tubal ligation. 5 of the patients

(10%) had infertility for unidentified causes.

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MR HYSTEROSALPHINGOGRAPHY

Out of the 40 patients, 16 patients had tubal block either unilateral or

bilateral. 24 patients had bilateral patency. Of the 16 patients, 13 patients had

bilateral block and 3 patients had unilateral block. Considering the total number

of tubes studied in 40 patients 29 tubes were found to be blocked and 51 tubes

were patent.

In our study 60% of the patients had bilateral patency and 40% had

bilateral block which is similar to the study by Cipolla et al (63) in which 65%

had patent tubes, 35% had unilateral or bilateral block..

In the primary infertility group 17 of the 22 patients had bilateral tubal

patency. 5 patients had tubal block and all 5 were bilateral block.

In the secondary infertility group 7 of the 18 patients had patent tubes. 11

patients had tubal block of which 3 had unilateral block and 8 had bilateral

block.

Evaluating the right sided tubes with MR hysterosalphingography, 26

tubes (65%) were patent and 14(35%) were blocked. When classified according

to the age there were 15 patients in the age group of 20 -25 years, of which 11

tubes were patent and 4 were blocked. In the age group of 26 -30 years, there

were 12 patients of which 7 tubes were patent and 5 were blocked. In the age

group of 31 – 40 years, there were 13 patients of which 8 tubes were patent and

5 were blocked. Of the 35% of blocked right sided tubes 10% were in 20 – 25

years, 12.5% were in 26- 30years and 12.5% in 31- 40 years. There was no

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statistically significant difference in tubal patency (p = 0.68) according to the

various age groups.

Evaluating the left sided tubes with MR hysterosalphingography 25

tubes (62.5%) were patent and 15(37.5%) were blocked. When classified

according to the age out of 15 patients in the age group of 20 -25 years, of

which 10 tubes were patent and 5 were blocked. In the age group of 26 -30

years, out of 12 patients 8 tubes were patent and 4 were blocked. In the age

group of 31 – 40 years, out of 13 patients 7 tubes were patent and 6 were

blocked. Of the 37.5% of blocked right sided tubes 12.5% were in 20 – 25

years, 10% were in 26- 30years and 15% in 31- 40 years. There was no

statistically significant difference in tubal patency (p = 0.73) according to the

various age groups.

When classified according to the years after marriage as three groups

from 1 – 5years, 6 -10 years, 11 – 15 years there were 23 patients in 1- 5 years

group, 10 patients in 6 – 10 years group and 7 patients in 11 – 15 years group.

Evaluating the right sided tubes with MR hysterosalphingography, out

of the 23 patients in 1- 5 years group 18 tubes were patent and 5 were blocked.

Out of the 10 patients in 6 – 10 years group 4 tubes were patent and 6 were

blocked. Out of the 7 patients in 11 – 15 years group 4 tubes were patent and 3

were blocked. There was no significant difference in tubal patency (p = 0.09)

considering age after marriage.

Evaluating the left sided tubes with MR hysterosalphingography, out of

the 23 patients in 1- 5 years group 18 tubes were patent and 5 were blocked.

Out of the 10 patients in 6 – 10 years group 4 tubes were patent and 6 were

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blocked. Out of the 7 patients in 11 – 15 years group 3 tubes were patent and 4

were blocked. There was no significant difference in tubal patency (p = 0.05)

considering age after marriage.

There were 9 patients with post tubal reanastamosis status and 31

patients without such history. Evaluating the right sided tubes with MR

hysterosalphingography out of the 9 tubes, 3 tubes were patent and 6 were

blocked. Where as in the remaining 31 patients 23 tubes were patent and 8

were blocked. There was statistical difference in tubal patency (p = 0.02) after

reversal of tubal ligation.

Evaluating the left sided tubes with MR Hysterosalphingography out of

the 9 tubes, 3 tubes were patent and 6 were blocked. Of the remaining 31

patients 22 were patent and 9 were blocked. There was statistical significance

in tubal patency (p = 0.04) after reversal of tubal ligation in left sided tubes

also.

CONVENTIONAL HYSTEROSLAPHINGOGRAPHY

In conventional HSG group also there were 16 cases of tubal block

either unilateral or bilateral and 24 cases of tubal patency. But a case of

primary infertility which showed bilateral block in MR

Hysterosalphingography was found to have unilateral block in the conventional

method. It was the only case in which there was discordance between MR and

conventional methods. Whereas in all other cases the results were concordant

between MR and conventional hysterosalphingography.

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Sadowski et al (5) in their study identified 6 tubes which were blocked in

conventional method were actually patent in MR hysterosalphingography due

to better resolution of MRI, but it was not accepted by James (59) stating that

the increased patency was only due to the plastic catheter instead of metallic

cannula. It was not a confounding factor in our study as the same catheter was

used in both MR and conventional HSG except in one case where the balloon

catheter was dislodged after MR hysterosalphingography and thus proceeded

conventional HSG with a metallic cannula.

Our results are also supported with the study conducted by Unterwerger

et al(6) in which 8 out of the 10 cases showed concordant results in both MR and

conventional HSG

DIAGNOSTIC LAPAROSCOPY

In diagnostic laparoscopy all patients with bilateral patency in MR and

conventional hysterosalphingography were found to be patent. Among the

patients with tubal block 7 had unilateral block and 9 had bilateral block.

6 patients with bilateral block in MR hysterosalphingography were

found to have unilateral block in diagnostic laparoscopy.5 patients with

bilateral block in conventional hysterosalphingography were found to have

unilateral block in diagnostic laparoscopy. The increased patency in diagnostic

laparoscopy might be attributed to the fact that the tubes were opened during

the previous two procedures as stated by Sadowski et al(5)

Our results are comparable with the study done by Winter et al(60) in

which 27 out of 33 patients had bilateral tubal patency and 1 out of 6 patients

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with bilateral block was confirmed at laparoscopy. In the study by Winter et al

tubal cathetrisation was done in two patients and in three out of the remaining 6

patients with bilateral tubal block neither conventional HSG nor laparoscopy

could be done.

Considering individual tubes in 40 patients, the total number of tubes is

80.

In MR hysterosalphingography out of the 80 tubes, 51 tubes were patent

and 29 tubes were blocked.In conventional hysterosalphingography out of the

80 tubes 52 tubes were patent and 28 tubes were blocked.In diagnostic

laparoscopy out of the 80 tubes 55 tubes were patent and 25 tubes were

blocked.

The Kappa agreement between MR hysterosalphingography and

conventional hysterosalphingography was 0.94 for right sided tubes and there

was no statistical difference between the two procedures with McNemar test

value of 1. (Significant if value < 0.05). The Kappa agreement between MR

hysterosalphingography and conventional hysterosalphingography was 1.0 for

left sided tubes, and there was no statistical difference between the two

procedures (Mcnemar test value - 1.0). These statistical tests prove the high

degree of concordance between MR and conventional hysterosalphingography.

The Kappa agreement between MR hysterosalphingography and

diagnostic laparoscopy was 0.88, compared to the agreement between

conventional hysterosalphingography and diagnostic laparoscopy which was

0.94 for right sided tubes.The Kappa agreement between MR

hysterosalphingography and diagnostic laparoscopy was 0.88 compared to the

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agreement between conventional hysterosalphingography and diagnostic

laparoscopy which was 0.89 for left sided tubes.

The sensitivity, specificity, positive predictive value (PPV), negative

predictive value (NPV), diagnostic accuracy of MR hysterosalphingography in

comparison to conventional hysterosalphingography were 100%, 98.08%,

100%, 96.5%, 98.75% respectively.

The sensitivity, specificity, positive predictive value (PPV), negative

predictive value (NPV), diagnostic accuracy of MR hysterosalphingography in

comparison to diagnostic laparoscopy were 100%, 92.73%, 86.21%, 1005,

95% respectively.

Fatemeh et al (65) in their study stated the sensitivity and specificity of

HSG in detecting bilateral tubal patency or tubal block is 92.1%, 85.7%

respectively. The positive predictive value, negative predictive value,

diagnostic accuracy were 97.2%, 66.7% and 91.1%.

The extra tubal factors identified in our study were 4 cases of congenital

uterine anomalies (1 bicornuate, 3 septate), 2 cases of myoma, 3 cases of

complex ovarian cysts,6 cases of polycystic ovaries and 1 case of endocervical

polyp. Sadowski et al (5) identified 3 cases of myomas, 2 cases of uterine

anomalies (1 arcuate, 1 partial septate), 1 hydrosalphinx, 1 endometrioma and 1

atrophic ovary.

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CONCLUSION

MR hysterosalphingography is a novel upcoming investigation with

very few pioneering studies at both national and international levels. The study

is one of its kind exploring the utility and feasilbilty of HSG being done using

MRI.

MRHSG gives promising results as good as the age old investigation of

Xray HSG. In addition it picks up uterine and extra uterine pathologies

determining the management protocol in infertility. It also has the added

advantage of avoidance of radiation exposure to the potential reproductive

organs and use of highly diluted contrast.

MR hysterosalphingography incorporated in MRI of pelvis in infertility

protocol has a great way in the future.

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ABBREVIATIONS

1. HSG - Hysterosalphingography

2. MR HSG - Magnetic Resonance Hysterosalphingography

3. DL - Diagnostic Laparoscopy

4. T1W - T1 weighted

5. T2W - T2 weighted

6. TR - Time to repeat

7. TE - Time to Echo

8. A - Abortion

9. P1 - Para1

10. P2 - Para2

11. L - Live children

12. Nulli - Nullipara

13. RT - Right

14. LT - Left

15. P - Patent

16. B - Block

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PROFORMA

STUDY TITLE:

“COMPARATIVE STUDY OF ASSESSMENT OF TUBAL

PATENCY IN FEMALE INFERTILITY BETWEEN MR

HYSTEROSALPHINGOGRAPHY AND CONVENTIONAL

HYSTEROSALPHINGOGRAPHY WITH DIAGNOSTIC

LAPARSCOPY AS GOLD STANDARD”

Sl.No:

Name :

Age/Sex :

Occupation :

Address :

Menstrual History:

Marital History:

Sexual history:

Obstetric history:

Surgical history:

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FINDINGS:

MR HYSTEROSALPHINGOGRAPHY:

PATENCY RIGHT TUBE:

PATENCY LEFT TUBE:

OTHER FINDINGS:

CONVENTIONAL HYSTEROSALPHINGOGRAPHY:

PATENCY RIGHT TUBE:

PATENCY LEFT TUBE:

DIAGNOSTIC LAPAROSCOPY:

PATENCY RIGHT TUBE:

PATENCY LEFT TUBE:

Signature of Investigator Signature of the Participant

Witness:

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INFORMED CONSENT FORM

Title of the study:” COMPARATIVE STUDY OF ASSESSMENT OF TUBAL

PATENCY BY MR HSG AND CONVENTIONAL HSG WITH DIAGNOSTIC

LAPAROSCOPY AS GOLD STANDARD”

Name of the Participant:

Name of the Principal (Co-Investigator):

Name of the Institution:

Name and address of the sponsor / agency (ies) (if any):

Documentation of the informed consent

I have read the information in this form (or it has been

read to me). I was free to ask any questions and they have been answered. I am over 18

years of age and, exercising my free power of choice, hereby give my consent

to be included as a participant in the study.

1. I have read and understood this consent form and the information

provided to me.

2. I have had the consent document

explained to me.

3. I have been explained about the

nature of the study.

4. I have been explained about my rights and responsibilities by

the investigator.

5. I have been informed the investigator of all the treatments I am taking or have

taken in the past months including any native (alternative) treatment.

6. I have been advised about the risks associated with my participation

in this study.*

7. I agree to cooperate with the investigator and I will inform him/her

immediately if I suffer unusual symptoms. *

8. I have not participated in any research study within the past

month(s). *

9. I have not donated blood within the past months(Add if the study

involves extensive blood sampling). *

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10. I am aware of the fact that I can opt out of the study at any time without having to

give any reason and this will not affect my future treatment in this hospital. *

11. I am also aware that the investigator may terminate my participation in the study at

any time, for any reason, without my consent. *

12. I hereby give permission to the investigators to release the information obtained

from me as result of participation in this study to the sponsors, regulatory

authorities, Govt. agencies, and IEC. I understand that they are publicly presented.

13. I have understand that my Identity will be kept confidential if my data are

publicly presented

14. I have had my questions answered to

my satisfaction.

15. I have decided to be in the

research study.

I am aware that if I have any question during this study, I should contact the

investigator. By signing this consent form I attest that the information given in this

document has been clearly explained to me and understood by me, I will be given a

copy of this consent document

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For adult participants:

Name and signature / thumb impression of the participant (or legal representative if

participant incompetent)

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PATIENT INFORMATION SHEET

Investigator (principal and at least one Co-investigator):DR.M.S Fouzal Hithaya

Name of Participant:

Title: Comparative study of assessment of tubal patency in female infertility between MR

Hysterosalphingography and conventional hysterosalphingography with diagnostic

laparoscopy as gold standard.

You are invited to take part in this research/ study /procedures. The information in this

document is meant to help you decide whether or not to take part. Please feel free to ask

if you have any queries or concerns.

You are being asked to participate in this study being conducted in Kilpauk Medical

Medical College,Chennai-10.

Hysterosalphingography is one of the several tests done in patients coming for infertility

evaluation. Its chief aim to identify whether the fallopian tubes are patent. If there is

block in fallopian tubes there will be difficulty in conception and that leads to infertility.

There are several methods to do hysterosalphingography (HSG). It can be done using X

ray, ultrasound.

MRI of pelvis has become an invaluable tool in evaluation of infertility in the present

scenario. It depicts all kinds of uterine and extra uterine factors that may lead to

infertility. Doing hysterosalphingography by MRI is a new technique that is recently

developing. No previous studies have been conducted in its regard so far in the

department. By doing MR HSG we can combine the benefits of MRI with

hysterosalphingography. So this study aims at developing the method of doing it so that it

can be incorporated in infertility evaluation in near future in our hospital. If done

successfully it will be of great help to the patients coming for infertility evaluation.

Study Procedures

First you will be placed in lithotomy position so that the HSG catheter can be placed in

situ within the uterine cavity for the purpose of doing the procedure. It will be done under

strict aseptic conditions. After doing so you will be shifted to 1.5 T MRI scanner. Routine

sequences will be initially obtained. Then 10 ml of saline with few drops of MRI contrast

will be injected through the catheter placed in the uterine cavity. Subsequent sequences

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are obtained so as to look for tubal patency which will be shown by the spill of the

contrast in the peritoneal cavity.

Then you will be subsequently shifted to the Xray room safely in a stretcher. Again 10 ml

of X ray contrast will be injected through the same catheter and tubal patency will be

looked for by taking a spot film. The catheter will be removed safely. You will be given

adequate pain killers and antibiotics as required.

If you are found to have tubal block you will be asked to undergo diagnostic laparsocopy

subsequently in department of Obstetrics and Gynaecology at Kilpauk Medical College.

If you are found to have patent tubes, you will be asked to review after a period of 3

months. If you fail to conceive you will have to undergo diagnostic laparoscopy.

Possible Risks to you

Risks of this procedure is rare and includes

Cramping pain: You may have cramping pain during the procedure but it

will be minimised by pain killers.

Bleeding: You may have minimal spotting/ bleeding per vaginum after the

procedure but it will be self limiting.

Infections: Most of these are minor; however it can be prevented by

adequate antibiotics.

Possible benefits to other people

The result of the research may provide benefits to the society in terms of advancement of

medical knowledge and/or therapeutic benefits to future patients

Confidentiality of the information obtained from you

You have the right to confidentiality regarding the privacy of your medical information

(personal details, results of physical examinations, investigations, and your medical

history). By signing this document, you will be allowing the research team investigators,

other study personnel, sponsors, IEC and any person or agency required by law like the

Drug Controller General of India to view your data, if required.

The information from this study, if published in scientific journals or presented at

scientific meetings, will not reveal your identity.

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How will your decision to not participate in the study affect you?

Your decisions to not participate in this research study will not affect your medical care

or your relationship with investigator or the institution. Your doctor will still take care of

you and you will not loose any benefits to which you are entitled.

Can you decide to stop participating in the study once you start?

The participation in this research is purely voluntary and you have the right to withdraw

from this study at any time during course of the study without giving any reasons.

However, it advisable that you talk to the research team prior to stopping the treatment.

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S.

N

O

NAME AGE MARRIED

FOR

OBSTETRIC

HISTORY

MR HSG CONVENTIONAL

HSG

DL

RT

TUBE

LT

TUBE

RT

TUBE

LT

TUBE

R

T

LT

1. KAVITHA 32 14YRS NULLI P P P P P P

2. MALAR 22 4YRS NULLI P P P P P P

3. MEENATCHI 31 8YRS P1L1 P P P P P P

4. JEEVITHA 25 4YRS A2 P P P P P P

5. PRIYA 27 3YRS NULLI P P P P P P

6. EZHILARASI 31 5YRS A2 P P P P P P

7. KALA 29 3YRS NULLI P P P P P P

8. NITHYA 20 2YRS NULLI P P P P P P

9. PADMAVATHY 25 2YRS NULLI P P P P P P

10. RANI UE 31 7YRS P1L1 P P P P P P

11. ARUNA 24 2YRS NULLI P P P P P P

12. KASTHURI 39 12YRS P2L1 P P P P P P

13. GEETHAPRIYA 27 2YRS NULLI P P P P P P

14. UMA 29 7YRS NULLI P P P P P P

15. SUDHA 21 2YRS NULLI P P P P P P

16. DURGADEVI 24 2YRS A2 P B P B P B

17. BHAVANI 30 9YRS P2L2 B B B B B B

18. ZEENATH 35 12YRS P2L1 P B P B P B

19. SHENBAGAM 25 2YRS NULLI P P P P P P

20. REVATHI 24 2YRS NULLI P P P P P P

21. KALPANA 26 3YRS NULLI P P P P P P

22. KANNAGI 30 6YRS P2L1 B B B B B B

23. PALLAVISELVI 32 5YRS A2 P P P P P P

24. MAHALAKSHMI 37 12YRS P2L1 P P P P P P

25. TAMILSELVI 32 8YRS P2L1 B B B B B B

26. NALINI 35 13YRS P1LI B B B B B B

27. MANJULA 25 4YRS P2L2 B B B B B B

28. JYOTI 32 6YRS NULLI B B B B P B

29. GEETHA 24 2YRS NULLI B B P B P B

30. AYESHA 25 2YRS NULLI P P P P P P

31. NOORJAHAN 25 3YRS NULLI P P P P P P

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32. SEVATHA 26 4YRS NULLI B B B B B P

33, MAHALAKSHMI 39 14YRS P2L1 B B B B B B

34. DHANALAKSHMI 28 4YRS NULLI P P P P P P

35. SUHASHINI UE 29 8YRS P1L1 B B B B B B

36. DHILARA UE 38 15YRS P2L2 B B B B B P

37. MANGALAKSHMI 23 2YRS NULLI B B B B B B

38. THIRUMATHI 28 4YRS P2L1 B P B P B P

39. DHANALAKSHMI 25 6YRS NULLI B B B B

B B

40 PARAMESHWARI 28 6YRS NULLI P P P P P P


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