Role of Saline Infusion Sonohysterography in Infertility Evaluation.

INTRODUCTION: Etiology of infertility is multifactorial, and fallopian tube abnormality being one of the most important causes accounts for up to 40% of female subfertility if not less and is further increasing. Saline infusion sonohysterography (SIS) procedure is gaining popularity and is being widely practiced and accepted as a screening tool in assessing tubal patency in infertile patients attending infertility clinic and has become popular as a routine test for the evaluation of the uterine cavity in the investigation of infertility and abnormal uterine bleeding.
OBJECTIVE: To compare the results of SIS with that of hysterosalpingography in infertility evaluation and to observe the role of SIS to find out endometrial pathology and tubal patency in infertility patients.
MATERIALS AND METHODS: A retrospective, observational study was done on the basis of record maintained in the ultrasound register and case record sheets of all infertile women who underwent infertility treatment and fulfilled the inclusion criteria from June 2015 to August 2016.
RESULTS: SIS had sensitivity of 91%, specificity of 76% positive predictive value (PPV) of 95%, negative predictive value (NPV) of 66%, and accuracy of 89% of SIS in evaluating tubal patency. Further, SIS showed sensitivity of 83.3%, specificity of 60%, PPV of 75%, NPV of 75%, and accuracy of 72% in detecting pelvic pathology.
CONCLUSION: In a low-resource country like India where patients are also less educated, SIS can prove to be a useful tool in initial workup of infertility patients with better compliance, low cost, and better results in a single visit.

INTRODUCTION

Problem of infertility (subfertility) is increasing day by day in a country like India. According to the reports of the World Health Organization,[1] around 10% of women are facing problems of infertility globally. Etiology of infertility is multifactorial, and fallopian tube abnormality being one of the most important causes accounts for up to 40% of female subfertility if not less and is further increasing.[23] Hence, screening for tubal occlusion is one of the first important steps in fertility assessment of the investigation of subfertile couples. Till date, hysterosalpingography (HSG) is the preferred choice of investigation followed by laparoscopy with chromotubation.[4] HSG is a contrast-enhanced fluoroscopic radiological study which has been a standard test in the workup of infertile females. It not only gives information about tubal patency and contour but also helps to assess the uterine cavity giving information for its size, shape, contour, and filling defect, suggestive of polyp, septa, adhesions, fibroids, etc. It has its own drawbacks and limitations like iodinated contrast and X-rays are being used and is also painful and uncomfortable for the patients. Laparoscopy with chromopertubation is largely accepted as the gold standard for diagnosing tubal occlusion but is usually preferred for the assessment or treatment of other associated pelvic pathology. It is an invasive procedure also needing anesthesia, thus adding to the cost and side effects.

Saline infusion sonohysterography (SIS), also known as sonohysterography or hysterosonography procedure, is gaining popularity and is being widely practiced and accepted as a screening tool in assessing tubal patency in infertile patients attending infertility clinic[5] and has become popular as a routine test for the evaluation of the uterine cavity in the investigation of infertility and abnormal uterine bleeding.[6789] SIS can be done with B mode ultrasound (US) and Doppler. SIS refers to a procedure in which fluid is instilled into the uterine cavity transcervically through a catheter to provide enhanced endometrial visualization during transvaginal US examination.[1011] There are many studies that suggest application of SIS in evaluating uterine defects in patients with recurrent pregnancy loss as well as in those undergoing in vitro fertilization (IVF). SIS can demonstrate a patent tube; however, if blocked, the site of block is difficult to elicit. SIS aids in improved sonographic detection of endometrial pathologies, such as polyps, hyperplasia, leiomyomas, and sometimes adhesions. In addition, it can help in avoiding invasive diagnostic procedures in some patients as well as can optimize the preoperative evaluation process for those women who require therapeutic intervention. It is a well-tolerated technique, could be easily and rapidly performed at minimal cost, and has virtually lower risk of adverse effects and severe complications. The American College of Obstetricians and Gynecologists in conjunction with the American College of Radiology and the American Institute of Ultrasound in Medicine have developed a technology assessment document for saline infusion sonohysterography.[1213] The current study was done to observe the role of SIS to find out endometrial pathology and tubal patency in infertility patients and to compare the results of SIS with that of HSG in infertility evaluation.

Primary objective

The primary objective was to compare the results of SIS with that of HSG in infertility evaluation.

Secondary Objective

The secondary objective was to observe the role of SIS to find out endometrial pathology in infertility patients.

Study methodology

A retrospective observational study was done on the basis of record maintained in US register and case record sheets of all infertile women who underwent infertility treatment and fulfilled the inclusion criteria from June 2015 to August 2016 at our gynecology outpatient department. After revising the test validity parameters of HSG in comparison to SIS from the literature at alpha = 0.05 and a study power of 80%, a total sample size of minimum 90 participants was calculated after adding a 10% for possible drop out cases during the study. Initial workup of detailed clinical history to identify possible predisposing factors leading to infertility and the duration of symptoms was obtained from all the patients. According to standard treatment protocol, all patients had undergone detailed general examination as well as pelvic examination. Routine laboratory investigations such as screening patients for anemia and blood grouping Rh typing, 75 g 2-h glucose tolerance test, rapid plasma reagin, spouse's semen analysis, serum thyroid-stimulating hormone, prolactin, and human immunodeficiency virus test (on opt-out basis) were done before undergoing SIS. SIS was performed on the 7th or 8th day of the menstrual cycle. They were first subjected to baseline transvaginal sonography (TVS) and then sonosalpingograpy. Their outcome of diagnosing tubal patency was subsequently analyzed to compare the results of SIS with HSG done by an independent observer in the evaluation of uterine cavity and tubal patency. The primary outcome of the study was to test parameters of saline infusion sonography (SIS) and HSG in terms of sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).

Procedure for saline infusion sonohysterography

Procedures were done after obtaining valid informed consent. Premedication with ibuprofen 500 or hyoscine 10 mg was given ½ h before the procedure. Emergency cart was kept ready for any vasovagal attack. A bimanual examination was performed, Cusco's self-retaining speculum inserted, antiseptic cleaning of the cervix and vagina was performed, and a Foleys catheter of size-8 was introduced into the external os with the help of artery forceps, which was kept intracervically. In patulous os, it was kept above internal os, 2–3 ml of normal saline was pushed to inflate the bulb. Around 20 ml normal saline was kept ready with a 20 ml syringe. After removing stellate of catheter, normal saline was slowly pushed into catheter. Maximum 50 ml of normal saline was instilled. Once adequate distension of uterine cavity achieved, a sagittal sweep from cornua to cornua followed by an axial sweep from fundus to external cervical os was performed with a transvaginal probe. The cavity was evaluated for the presence of any abnormality. Subsequently, each tube was visualized separately for the presence of fimbrial turbulence (waterfall sign) which was taken as a sign of tubal patency. The presence of fluid in pouch of Douglas after SIS was also taken as a sign of tubal patency.

Parameters studied

Endometrial thickness

Length of endometrial cavity

Contour of endometrial cavity

Any detectable mass with its dimension

Filling defect inside cavity

Myometrial thickness

Dimension of uterus

Any congenital anomaly of uterus noticed coincidentally

Tubal passage of fluid and air bubble (indicator of tubal patency)

Fluid collection in pouch of Douglas.

Inclusion criteria

All cases of primary infertility

All cases of secondary infertility

Previous history of recurrent spontaneous abortion.

Exclusion criteria

Suspected case of genital tuberculosis

Pelvic infection

Active vaginal bleeding

Suspected pregnancy

Genital malignancy.

Type of study

This was a retrospective observational study.

The study was conducted at the Department of Obstetrics and Gynecology, AIIMS Raipur.

RESULTS

Table 1 highlights the demographic characteristics of patients, and there were more cases of primary infertility (73.4%) than secondary infertility (26.6%). Approximately 84% of the patients fall between age group of 23 and 32 years.

Table 1

Demographic characteristic

Table 2 shows that SIS was superior to HSG in picking up pelvic organ pathology and definitely had an added advantage of detecting adnexal pathology which HSG lacked.

Table 2

Pelvic organs abnormalities

All the patients who showed pathology or any abnormality were subjected for diagnostic hysterolaproscopy. Hence, from Table 3, it is evident that SIS is superior to HSG in picking up pelvic organ pathology which was confirmed by diagnostic hysterolaproscopy [Figures 1-5].

Table 3

Uterine and adnexal pathology

Figure 1

Endometrial polyp on saline infusion sonography

Figure 5

Synechiae

Sessile endometrial polyp

Submucous fibroid

Bicornuate uterus with two endometrial lining

Table 4 shows that SIS detected 15 tubes with bilateral block, of which HSG showed only 10 tubes with bilateral occlusion and laparoscopy agreed to only eight occluded tubes [Figures 6-7]. Hence, concordance is 53.3% in SIS and 66.7% in HSG.

Table 4

Tubal patency on saline infusion sonohysterography versus hysterosalpingography

Figure 6

Blocked tubes on saline infusion sonography

Figure 7

Bilateral patent tubes on SIS

Table 5 summarizes the findings of the current study showing sensitivity of 91%, specificity of 76%, PPV of 95%, NPV of 66%, and accuracy of 89% of SIS in evaluating tubal patency. Furthermore, SIS showed sensitivity of 83.3%, specificity of 60%, PPV of 75%, NPV of 75%, and accuracy of 72% in detecting pelvic pathology.

Table 5

Results of diagnostic test

DISCUSSION

Infertility is constantly growing in developing countries like India. India being a low-resource country, patients cannot always afford multiple visits and we need to set a management protocol in which maximum abnormalities and pathologies could be detected in a single visit. Baseline sonography is needed to be done in all infertile patients to look for antral follicular count, ovaries, pathology in the uterus, adnexa, and uterine cavity and also to check for tubal patency. Saline infusion sonography is the single most investigation which when done on day 8–9 can reveal maximum information in an average time span of 10–15 min. Baseline TVS would detect any uterine pathologies such as fibroid, ovarian mass, and polyp and also give idea of growing follicle and its size and any fluid in pouch of Douglas. In a the meta-analyses by Seshadri et al.,[14] SIS was declared as having a high degree of diagnostic accuracy in the detection of all types of intrauterine abnormalities with a sensitivity and specificity of 88 and 94%, respectively. SIS is quite efficient in analyzing various endometrial pathologies such as endometrial polyps, submucous myomas, intrauterine adhesions, septas, and many other congenital uterine anomalies. Hence, any patient suspected of having an endometrial pathology on conventional transvaginal scan, SIS must be done before advising hysteroscopy especially as there are few studies depicting comparable accuracy in detecting these pathologies. With advancement in US imaging, SIS and hysterosalpingo-contrast sonography are replacing HSG for the evaluation of the uterine cavity and fallopian tubal patency in many centers worldwide.[514]

Our study compared the performance of SIS in diagnosing tubal patency in comparison to HSG keeping HSG as the gold standard. In addition, all those patients in whom tubal block was suspected or any pelvic pathology detected underwent diagnostic hysteroscopy with laparoscopy along with chromopertubation. The test performance parameters of SIS in terms of accuracy in detecting tubal patency were comparable to HSG being approximately 90%. SIS was much superior to HSG in detecting pelvic pathology in terms of sensitivity, specificity, PPV, NPV, and accuracy. In our study, SIS detected 15 tubes with bilateral block of which HSG showed only 10 tubes with bilateral occlusion and laparoscopy agreed to only eight occluded tubes. Hence, concordance is 53.3% in SIS and 66.7% in HSG. These results are inferior to previous studies, which have yielded concordance values between 83 and 86%.[151617]

The test results of our study showed sensitivity of 91%, specificity of 76%, PPV of 95%, NPV of 66%, and accuracy of 89% of SIS in evaluating tubal patency. Furthermore, SIS showed sensitivity of 83.3%, specificity of 60%, PPV of 75%, NPV of 75%, and accuracy of 72% in detecting pelvic pathology. Similar study by Pujar et al.[18] showed slightly better results of SIS in assessing tubal patency and detecting pelvic pathology. We found that SIS was very accurate in detecting tubal patency both by seeing turbulence of fluid flowing in the tubes and also by collection of fluid in pouch of Douglas, but we had difficulty in detecting side-specific tubal patency as probably the turbulence was altered in the tubes with block. It was obvious from our study that SIS had more sensitivity but less specificity than hysteroscopy or HSG in the diagnosis of uterine cavity pathology. Hysteroscopy definitely gives most accurate results in the diagnosis of endometrial pathology when compared with SIS, but SIS can very well be incorporated as a screening tool of all infertile patients with more advantages than disadvantages. According to one study, HSG cannot be considered a reliable and accurate method for the diagnosis of tubal patency.[19]

There is a study which also complies with our results and shows that SIS is a highly sensitive and specific investigative modality and is comparable to the gold standard tool hysteroscopy in the diagnosis of intrauterine pathology and can be utilized as screening tool for subfertile patients before taking them for IVF treatment.[14] Another study declared that routine SIS was only beneficial in patients with any suspicious findings on TVS (including extracavitary lesions) than in those with normal TVS.[20]

CONCLUSION

Saline infusion sonography is becoming a popular diagnostic tool for the evaluation of tubal patency and uterine pathology (both intracavitary and extracavitary) in patients with infertility. In a low-resource country like India, SIS can prove to be a useful tool in initial workup of infertility patients with better compliance, low cost, and better results in a single visit. SIS should be the investigation of choice, and HSG and laparoscopic chromopertubation should only be reserved for those patients with doubtful diagnosis in saline infusion sonography or with long duration unexplained infertility.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.