Malik, Bhumika MBBS, DNB; Patil, Shaifali MD, DGO; Boricha, B. G. MD, DGO; Kurkal, Nidhi MBBS; Choudhry, Minal MD
One of the major problems of human reproduction that haunts many men and women is relative infertility, which may affect 10% to 15% of reproductive age couple. Infertility is defined as 1 year of unprotected intercourse without pregnancy, primary in which no previous pregnancies have occurred and secondary in which a prior pregnancy, not necessarily a live birth, has occurred.1 Factors from either or both partners may contribute to difficulties in conceiving; therefore, it is important to consider all possible diagnoses before pursuing invasive treatment. The distribution of the causes of infertility is population dependent.2 Male factors contribute to 25% to 40% of the cases while female factors may be ovulatory dysfunction (30%–40%), tubal or peritoneal factors (30%–40%), unexplained infertility (10%–15%), or miscellaneous causes (10%–15%).1
Tubal factors affect fertility in 18% to 81% of female infertile patients, depending on population3–6; hence, evaluation of tubal patency is essential in investigation of female infertility. Tubal factors not only contribute to major etiologic factors but also pose perplexing problems in diagnosis. Disorders of the tube may be pathological or functional. Pathological blockage can be secondary to any pelvic pathology, particularly inflammatory in origin, or it may be due to the congenital defects in the tube.7 However, because of the development of microsurgical procedures, the diagnosis and management of the tubal factors have taken a new run. Thus, the evaluation of uterotubal factors is an essential step in infertility work. There are various invasive and noninvasive diagnostic procedures to evaluate uterine and/or tubal pathology. The noninvasive or minimally invasive modalities are ultrasonography, sonosalpingography (SSG), and magnetic resonance imaging. The invasive modalities are hysterosalpingography (HSG), hysteroscopy, and laparoscopy. It would be beneficial if a way could be found to assess the uterine and/or tubal pathology using a relatively minimal invasive approach and also that is cost-effective.
The basic principle of SSG is to distend the uterine cavity with isotonic saline, which will delineate the contour, identify intrauterine pathology and thickness of endometrium, and also show the presence of fluid in the pouch of Douglas. Sonosalpingography is more precise in accurately detecting intrauterine abnormalities and measuring endometrial thickness and also the tubal patency. It is simple, safe, and easy to perform and unlike HSG is devoid of radiation hazards and the risk of allergy to iodine contrast.8 It is also noninvasive and does not require anesthesia unlike hysteroscopy and laparoscopy. The present study is done to assess the diagnostic accuracy of sonohysterography as compared with HSG.
MATERIALS AND METHODS
This study was a cross-sectional study. Thirty women with primary or secondary infertility with unknown uterine or tubal factors who attended the outpatient department (OPD) of the Department of Obstetrics & Gynaecology, Mahatma Gandhi Memorial Hospital, Kalamboli, Navi Mumbai, Maharashtra, India, from May 2010 to May 2011 were included. The study was a prospective design and had the approval of the ethics committee. All infertile women who were willing to give consent were included. Those who did not have any active bleeding or pelvic infection and who did not have a previous allergic reaction to iodine-based dyes were excluded from the study. The patients underwent an SSG on day 7 of the menstrual cycle and an HSG on day 9 of the same or next menstrual cycle. Sonosalpingography was considered as the reference standard for HSG.
On SSG, the Sion test was performed with the aid of a transvaginal sonography (TVS). The ultrasonography machine used had real-time and M mode as well as duplex color Doppler imaging and a frequency of 5-MHz transvaginal probe was used. Atropine, tetanus toxoid, and N-butylscopolammonium bromide (Buscopan) were given intramuscularly 15 minutes before the procedure. A Foley catheter (8F) was inserted into the uterine cavity, and the bulb of the catheter was instilled with 5 mL of saline and withdrawn until the level of the internal os to secure its position. The transvaginal probe was inserted above the catheter in anteverted uteri and below the catheter in retroverted uteri, and scanning was started in both transverse and sagittal sections. Thirty to 40 mL of normal saline mixed with 60 mg of gentamicin mixed with air was instilled in the uterine cavity. The flow of the saline as well as the micrometer-sized air bubbles was observed in both tubes. Forward flow of saline for 5 seconds within the tube without interruption or hydrosalpinx formation was considered as positive for tube patency. Bilateral blockage was characterized by reflux of saline and groin pain, and patients were given oral antibiotics (tablet doxycycline 100 mg twice a day and metronidazole 400-mg tablet thrice a day for 7 days) along with antispasmodics (mefenamic acid) when needed.
Patients were then taken for an HSG on day 9 of their menstrual cycle. All patients were administered atropine 0.6 mg intramuscularly before the procedure. The cervix was cleaned with antiseptic (povidone-iodine), and the anterior lip was grasped with a tenaculum. A Rubin cannula or Colwin’s Cannula was introduced, and an initial radiograph was obtained. The contrast medium used was an iodine-based dye (20 mL), which was then slowly instilled into the uterine cavity over 15 minutes, and 3 more films were obtained. The first film gave an idea of the pelvic anatomy; the second showed the dye reaching the vaginal canal and uterine cavity; the third showed the dye into the fallopian tubes, and the fourth film demonstrated the spillage of the dye into the peritoneal cavity. The shape of the tubes and the absence of any hydrosalpinx with spillage of dye into the peritoneal cavity were used as indicators of patency of unilateral or bilateral fallopian tubes.
All patients with any positive findings of uterine cavity anomalies and those with a diagnosis of unilateral or bilateral blocked fallopian tubes underwent hysterolaparoscopy along with chromopertubation, which was considered as the criterion standard, and patency was confirmed by direct visualization of spillage of dye into the peritoneal cavity.
Patients were evaluated by age, and comparison of SSG to HSG was done on the basis of the number of uterine cavity, tube abnormalities picked up, and the complaint of pain during or immediately after the procedure graded subjectively by the visual analog scale (VAS) scoring system. A VAS score of less than 3 was considered as mild pain; 4 to 7 was moderate pain, and more than 8 was considered as severe pain.
RESULTS AND ANALYSIS
A total of 30 patients were included in the study. The age range was from 21 to 38 years, with a mean age of 30.1 years. Mean duration of infertility was 7.7 years with a range of 2 to 20 years. Twenty-two patients (73.3%) in our study had primary infertility, and the remaining 8 (26.7%) had secondary infertility. Average time taken in our study for sonohysterography was 19.9 minutes.
Of 30 patients who underwent SSG, 3 patients had unilateral tubal block, of which 1 patient also had a submucous fibroid, and 1 patient had a septate uterus, and 4 patients had a diagnosis of bilateral tubal block among whom 1 had an endometrial polyp, and 1 had a bicornuate uterus. During HSG, only 2 of the 3 patients had a unilateral block with the finding of septate uterus in the previously diagnosed patients. Six patients, however, had a diagnosis of bilateral tubal block, of which 4 had intracavitary abnormalities, 2 with endometrial polyps, 1 with bicornuate uterus, and 1 with a submucous fibroid. Thus, 1 patient with unilateral block and yet another with patent tubes as per SSG had a diagnosis of bilateral block on HSG, and intracavitary abnormalities were picked up in 4 of these patients on SSG and 5 patients on HSG.
All 8 patients with abnormal results were further evaluated with hysterolaparoscopy with chromopertubation which was considered as the criterion standard. On hysteroscopy it was found that 4 patients had abnormalities in the uterine cavity as previously detected by SSG and 4 were normal. Thus for evaluation of uterine cavity, SSG had sensitivity of 100% and specificity of 100% while the sensitivity of HSG was 100% and specificity is 80% as confirmed with hysteroscopy.
On laparoscopy, 2 patients had a diagnosis of unilateral tubal block, both of which were picked up by SSG, whereas HSG had diagnosed 1 of them with unilateral and the other with a bilateral block. Five patients had a diagnosis of bilateral block, of which both HSG and SSG had diagnosed 4 with bilateral and 1 with unilateral block. One of the 8 patients had bilateral patent tubes as previously diagnosed by SSG when HSG had diagnosed the same patient to have bilateral blocked tubes. Thus, SSG had sensitivity of 95.8% and specificity of 100% for diagnosing tubal patency when compared with hysterolaparoscopy. The sensitivity of HSG was 91.7%, whereas specificity was 100%.
Twenty-two patients (73.3%) did not complain of any pain. Mild pain (VAS score <3) was found in 5 (16.7%) of patients. Three patients (10%) complained of moderate pain (VAS score 4–7) on SSG, whereas in HSG, 4 patients (13.3%) had mild, and the same number had moderate pain. The result though was not significant with P = 0.8. However, none of the patients required analgesics.
Only 2 of the patients with bilaterally blocked tubes gave a positive history, 1 with history of tuberculosis for which complete treatment with anti Koch’s treatment was taken and 1 with history of chronic pelvic disease. All 4 patients with bilaterally blocked tubes were offered surgery for recanalization of blocked tubes; however, only 1 patient accepted to undergo tuboplasty.
Uterine and tubal pathology is one of the major causes of infertility. Thus, evaluation of uterine and tubal factor becomes an essential step in infertility workup. Saline infusion sonohysterography or SSG is the term for ultrasound imaging of the uterine cavity, using sterile saline solution as a negative contrast medium. Sonosalpingography is a low-tech, low-cost, painless enhancement of transvaginal or transabdominal sonography, which obviates the need for diagnostic hysteroscopy in cases of abnormal uterine bleeding, reproductive failure, or abnormal endometrial images obtained with any modality. Hysterosalpingography became an accepted procedure in 1925 ever since the discovery of an effective medium lipiodol.9 However, it has its limitations and complications. It cannot be done in cases of pelvic infections and active uterine bleeding. It is associated with risks such as iodine allergy, pelvic infections, and pain. It can cause venous or lymphatic intravasation of medium and also involves the risks of radiation exposure.10 Transient distortion of uterine cavity by blood, mucus, debris, and air bubbles may produce false-positive results.11
For a long time, HSG was the sole procedure to detect intra uterine abnormalities and tubal patency. But it has an increased risk of infection and also has high false-positive rates. Then, in 1970s, the introduction of hysterolaparoscopy allowed the direct visualization of uterine cavity, which remains still as the criterion standard for identifying uterine abnormalities and tubal patency, but it is an operative procedure and requires anesthesia. For the first time in 1986, the instillation of sterile saline solution into the uterine cavity was described, which was called as sonohysterography, which is a noninvasive modality for evaluation of uterotubal factors in infertility. The basic principle of sonohysterography is to distend the uterine cavity with isotonic saline, which will delineate the contour and thickness of endometrium, detect intrauterine abnormalities such as polyp or submucous myoma, and show presence of fluid in pouch of Douglas to detect tubal patency. This method assists in diagnosis of abnormal endometrial echoes that cannot be adequately evaluated by conventional TVS.
In 1984, Richman et al12 distended the uterine cavities with 70% dextran through a rigid uterine cannula while performing transabdominal ultrasound in 34 patients and then compared the results with those of conventional HSG. In 1986, Randolph et al,13 using a similar approach but with sterile saline as the medium, sought to predict surgical findings in anesthetized women about to undergo laparoscopy or hysteroscopy. Fifty-three of 54 uteri were accurately described with their abnormalities and were detected with 98% sensitivity and 100% specificity. The advent of vaginal transducers brought reports of even clearer images obtained with infusion of sterile clear media through rigid cannulas, beginning with that of Deichert et al14 in Germany in 1988. In 1991, Mitri et al15 in South Africa, using an 8F Foley catheter in the cervix, demonstrated that saline infusion sonohysterography was more informative than conventional HSG. Fifty normal cavities were demonstrated by both methods, but 9 women had otherwise undetectable extracavitary myomas visible by ultrasound. A report from Bonilla-Musoles et al16 from Spain followed in 1992. They found that SSG, using a balloon catheter, had a sensitivity of 96%, a specificity of 97%, positive predictive value (PPV) of 96%, and negative predictive value of 97%. At the American Fertility Society Meeting in Washington, DC, in October 1990, the evaluation of intrauterine synechiae in infertility patients using a flexible 5F HS balloon catheter (Ackrad Laboratories, Cranford, NJ) for infusion of sterile saline was reported. The same technique, with either the balloon catheter or a 2-mm intrauterine insemination Soules catheter (Cook Co, Spencer, Ind), was used for evaluation of a variety of intracavitary abnormalities and reported at the American Institute of Ultrasound in Medicine meeting in Atlanta the following year.
In 1992, an analysis was done on 129 patients in Mumbai, India, by Allahbadia et al,17 on whom the Sion test was performed. This test entailed an insertion of an 8F Foley catheter into the uterine cavity and imaging of the uterus on transvaginal ultrasound in both sagittal and coronal planes. After briefly scanning the uterus and both ovaries, the probe is then focused on the left cornu of the uterus and the left ovary, and 20 mL of air mixed with saline is pushed through the catheter. The flow of the saline and the micrometer-sized air bubbles is observed on transverse section, and the microbubbles flow out into the peritoneal cavity with turbulence. The procedure is then repeated on the right side. It was offered as a simple, minimally invasive office procedure and forward flow of saline and microbubbles for at least 5 seconds without interruption or hydrosalpinx formation, and the “waterfall sign” (turbulent flow created by the microbubbles) if present bilaterally was diagnostic of patency. In patients who had nonpatent tubes, the Sion procedure was performed where the pelvis was flooded with 200 to 300 mL of the same fluid via Foley catheter or suprapubically via an 18-gauge needle if the patient had bilateral blocked tubes after thorough local infiltration using 2% xylocaine and then scanning done. This procedure could not only confirm the nonpatency but also diagnose any interfimbrial adhesions as well as peritubal and pelvic adhesions and loculated fluid in the cul de sac because the saline filled up the pelvis and could delineate all pelvic abnormalities. The study proved that the Sion test was 91.1% in agreement with hysterolaparoscopy results.17
A study was done on 40 infertility patients in whom the accuracy of SSG was compared with HSG and laparoscopy with chromopertubation for tubal patency. They found that SSG was having 97% correlation with laparoscopy and around 93% correlation with HSG. Thus, they concluded that transvaginal SSG is a simple, cost-effective, noninvasive test that can be used as screening procedure for the assessment of tubal patency in the initial workup of infertile women.18 The authors studied 65 infertile women who underwent sonohysterography, conventional TVS, HSG, and hysteroscopy. The objective of this study was to evaluate the diagnostic accuracy of sonohysterography in uterine cavity diseases in infertile patients and comparing its results with those of HSG and TVS. Sonohysterography had the same diagnostic accuracy as the criterion standard (hysteroscopy), whereas HSG showed a sensitivity of 50% and a PPV of 28.6%, and TVS had both sensitivity and PPV of 75%. For uterine malformations, HSG had a sensitivity of 77.8%, whereas TVS and HSG both had sensitivity of 75% in detection of intrauterine adhesion and PPV of 42.9% and 50%. Thus, they concluded that SSG was in general the most accurate test, and its diagnostic accuracy was markedly superior. In diagnosis of intrauterine adhesions, SSG had limited accuracy similar to that obtained by HSG with a high false-positive diagnosis rate.19 These results were consistent with our results, which showed that SSG had a sensitivity of 95% for detection of tubal patency as compared with the sensitivity of HSG (91%) for detection of tubal patency. In a study of 98 infertile patients who underwent sonohysterography and subsequently compared with hysteroscopy for the diagnosis of intrauterine pathology, it was found that sensitivity, specificity, and accuracy of TVS compared with hysteroscopy were 92%, 86%, and 89%, respectively. Sensitivity, specificity, and accuracy of SSG compared with hysteroscopy were 98%, 93%, and 96%, respectively. Comparing SSG with hysteroscopy, they found only 1 false-negative (1.0%) and 3 false-positive (3.0%) results at SSG.20 These findings too correlated with the results of our study.
A study was carried out on 200 infertile patients to evaluate the cause of infertility with a minimum cost involved using transvaginal SSG avoiding costly procedures such as laparoscopy, hysteroscopy, and hormonal assays. Sonosalpingography revealed bilateral patent tubes in 60% cases, and the remaining 40% cases showed either bilateral or unilateral block of the tubes. Thus, the study concluded that SSG is a simple, noninvasive, and a cost-effective mode of investigation that can be used as routine procedure in the initial workup of all infertile women.21 A prospective observational study was performed on 214 women with suspected intrauterine abnormalities to assess the efficacy of sonohysterography and was compared with hysteroscopy in uterine cavity evaluation. They found that sonohysterography was conclusive in 84%, failed in 5.6%, and inconclusive in 10.3%. They concluded that sonohysterography was able to replace 84% of outpatient diagnostic hysteroscopies in uterine cavity evaluation, and diagnostic hysteroscopy can be restricted to inconclusive or failed sonohysterography.22 A study on 186 patients with primary or secondary infertility was conducted for the evaluation of uterine and tubal pathologies. Diagnostic accuracy of sonohysterography was compared with HSG. They found that SSG had a sensitivity of 78.2% and specificity of 93% and PPV of 82.7% and negative predictive value of 91%. On HSG, these were 76.3%, 81.8%, 90.9%, and 59.2%, respectively. They concluded that sonohysterography is an easy, safe, accurate, and promising procedure for detection of female upper genital tract pathologies especially because it can differentiate specific uterine abnormalities.23 Our study showed, however, a higher sensitivity and specificity of SSG. This could have been due to the small sample size of this study.
Laparoscopy with chromopertubation is widely accepted as the criterion standard method for evaluating tubal patency. At present, this procedure is considered the most accurate test available for assessing tube-related subfertility. The advantages of this procedure include an ability to simultaneously evaluate the abdominal cavity in addition to other pelvic structures and also allow for therapeutic excision of endometriotic lesions as well as restoration of abnormal pelvic findings.24 Although laparoscopy has higher diagnostic merits, however, it additionally incurs high operative cost and operative and anesthesia-related risks and requires a period of postoperative recovery. Therefore, a low cost and risk methodological approach should be addressed as a “first-choice” investigation, which can be later followed by more complex or invasive procedure whenever needed.25 Tubal patency is routinely assessed by HSG, but it involves radiation exposure as well as risk of dye reaction or anaphylaxis.26,27 The incidence and the severity of pain during SSG are also much lower because agitated saline appears less painful, probably again because of the low osmolarity of the injected solution.15 Although this study does have limitations, namely, the small sample size and the fact that only the patients with abnormalities on either HSG or SSG were investigated further with hysterolaparoscopy, it does show that SSG has a higher sensitivity as well as specificity in diagnosing tubal patency as well as uterine cavity abnormalities.
Sonohysterosalpingography appears to be inexpensive, quick, and well-tolerable first-line diagnostic method for determining the tubal status and uterine cavity and can be performed at the time of conventional ultrasound scan in place of HSG and laparoscopy.24
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