Hysterosalpingo-foam sonography versus hysterosalpingography during fertility work-up: an economic evaluation alongside a randomized controlled trial.

STUDY QUESTION: What are the costs and effects of tubal patency testing by hysterosalpingo-foam sonography (HyFoSy) compared to hysterosalpingography (HSG) in infertile women during the fertility work-up? SUMMARY ANSWER: During the fertility work-up, clinical management based on the test results of HyFoSy leads to slightly lower, though not statistically significant, live birth rates, at lower costs, compared to management based on HSG results. WHAT IS KNOWN ALREADY: Traditionally, tubal patency testing during the fertility work-up is performed by HSG. The FOAM trial, formally a non-inferiority study, showed that management decisions based on the results of HyFoSy resulted in a comparable live birth rate at 12 months compared to HSG (46% versus 47%; difference -1.2%, 95% CI: -3.4% to 1.5%; P = 0.27). Compared to HSG, HyFoSy is associated with significantly less pain, it lacks ionizing radiation and exposure to iodinated contrast medium. Moreover, HyFoSy can be performed by a gynaecologist during a one-stop fertility work-up. To our knowledge, the costs of both strategies have never been compared. STUDY DESIGN, SIZE, DURATION: We performed an economic evaluation alongside the FOAM trial, a randomized multicenter study conducted in the Netherlands. Participating infertile women underwent, both HyFoSy and HSG, in a randomized order. The results of both tests were compared and women with discordant test results were randomly allocated to management based on the results of one of the tests. The follow-up period was twelve months. PARTICIPANTS/MATERIALS, SETTING, METHODS: We studied 1160 infertile women (18-41 years) scheduled for tubal patency testing. The primary outcome was ongoing pregnancy leading to live birth. The economic evaluation compared costs and effects of management based on either test within 12 months. We calculated incremental cost-effectiveness ratios (ICERs): the difference in total costs and chance of live birth. Data were analyzed using the intention to treat principle. MAIN RESULTS AND THE ROLE OF CHANCE: Between May 2015 and January 2019, 1026 of the 1160 women underwent both tubal tests and had data available: 747 women with concordant results (48% live births), 136 with inconclusive results (40% live births), and 143 with discordant results (41% had a live birth after management based on HyFoSy results versus 49% with live birth after management based on HSG results). When comparing the two strategies-management based on HyfoSy results versus HSG results-the estimated chance of live birth was 46% after HyFoSy versus 47% after HSG (difference -1.2%; 95% CI: -3.4% to 1.5%). For the procedures itself, HyFoSy cost €136 and HSG €280. When costs of additional fertility treatments were incorporated, the mean total costs per couple were €3307 for the HyFoSy strategy and €3427 for the HSG strategy (mean difference €-119; 95% CI: €-125 to €-114). So, while HyFoSy led to lower costs per couple, live birth rates were also slightly lower. The ICER was €10 042, meaning that by using HyFoSy instead of HSG we would save €10 042 per each additional live birth lost. LIMITATIONS, REASONS FOR CAUTION: When interpreting the results of this study, it needs to be considered that there was a considerable uncertainty around the ICER, and that the direct fertility enhancing effect of both tubal patency tests was not incorporated as women underwent both tubal patency tests in this study. WIDER IMPLICATION OF THE FINDINGS: Compared to clinical management based on HSG results, management guided by HyFoSy leads to slightly lower live birth rates (though not statistically significant) at lower costs, less pain, without ionizing radiation and iodinated contrast exposure. Further research on the comparison of the direct fertility-enhancing effect of both tubal patency tests is needed. STUDY FUNDING/COMPETING INTEREST(S): FOAM trial was an investigator-initiated study, funded by ZonMw, a Dutch organization for Health Research and Development (project number 837001504). IQ Medical Ventures provided the ExEm®-FOAM kits free of charge. The funders had no role in study design, collection, analysis, and interpretation of the data. K.D. reports travel-and speakers fees from Guerbet and her department received research grants from Guerbet outside the submitted work. H.R.V. received consulting-and travel fee from Ferring. A.M.v.P. reports received consulting fee from DEKRA and fee for an expert meeting from Ferring, both outside the submitted work. C.H.d.K. received travel fee from Merck. F.J.M.B. received a grant from Merck and speakers fee from Besins Healthcare. F.J.M.B. is a member of the advisory board of Merck and Ferring. J.v.D. reported speakers fee from Ferring. J.S. reports a research agreement with Takeda and consultancy for Sanofi on MR of motility outside the submitted work. M.v.W. received a travel grant from Oxford Press in the role of deputy editor for Human Reproduction and participates in a DSMB as independent methodologist in obstetrics studies in which she has no other role. B.W.M. received an investigator grant from NHMRC GNT1176437. B.W.M. reports consultancy for ObsEva, Merck, Guerbet, iGenomix, and Merck KGaA and travel support from Merck KGaA. V.M. received research grants from Guerbet, Merck, and Ferring and travel and speakers fees from Guerbet. The other authors do not report conflicts of interest. TRIAL REGISTRATION NUMBER: International Clinical Trials Registry Platform No. NTR4746.

Contrast Agent Reflux in Transvaginal 4-D Hysterosalpingo-Contrast Sonography: Influencing Factors and Coping Strategies.

ABSTRACT: Transvaginal 4-D hysterosalpingo-contrast sonography (TV 4-D HyCoSy) plays an important role in the detection and diagnosis of clinical female infertility. The purposes of this study were to analyze the influencing factors of TV 4murD HyCoSy complicated with contrast agent reflux and to provide evidence for clinical diagnosis and treatment. Female patients diagnosed as infertility by transvaginal hysterosalpingography from January 2021 to December 2022 were included. The characteristics of patients with and without contrast agent reflux were evaluated. Pearson correlation and logistic regression were conducted to analyze the related factors affecting the occurrence of contrast reflux. A total of 416 patients undergoing TV 4-D HyCoSy were included, and the incidence of contrast agent reflux in patients undergoing TV 4-D HyCoSy was 38.94%. Pearson correlation analysis results indicated that history of uterine cavity operation ( r = 0.556), adenomyosis of uterus ( r = 0.584), examination on less than 5 days after menstruation ( r = 0.602), endometrial thickness ( r = 0.566), and endometrial polyps ( r = 0.575) are all correlated with contrast agent reflux in patients undergoing 4-D HyCoSy (all P < 0.05). Logistic regression analysis showed that history of uterine cavity operation (odds ratio [OR], 1.109; 95% confidence interval [CI], 1.012-1.872), adenomyosis of uterus (OR, 2.026; 95% CI, 1.864-2.425), examination on less than 5 days after menstruation (OR, 2.465; 95% CI, 2.118-2.851), endometrial thickness less than 6 mm (OR, 2.866; 95% CI, 2.095-2.957), and endometrial polyps (OR, 1.587; 95% CI, 1.137-1.744) were the influencing factors of contrast agent reflux in patients undergoing (all P < 0.05). The incidence of contrast agent reflux in TV 4-D HyCoSy is high, and there are many influencing factors. Clinical medical workers should take early measures based on these influencing factors to reduce the contrast agent reflux.

Risk Factors of Contrast Agent Intravasation With Sulfur Hexafluoride Microbubble During Hysterosalpingo-Contrast Sonography.

OBJECTIVES: To analyze the risk factors of sulfur hexafluoride microbubble contrast agent intravasation during hysterosalpingo-contrast sonography (HyCoSy), and to explore a simple prediction model by the obvious clinical history. METHODS: This was a retrospective study included 299 infertility women who had undergone HyCoSy examination from July 1, 2018 to June 31, 2019. The factors were recorded, including age, endometrial thickness, balloon length, infertility type, history of intrauterine surgery, history of pelvic surgery, and tubal patency. The method of multivariate logistic regression analysis was adopted to analyze the risk factors affecting the contrast agent intravasation, and the receiver operating characteristic curves were plotted to test their efficacy. RESULTS: Secondary infertility, a history of intrauterine surgery, thin endometrial thickness, and tubal obstruction were all risk factors of the occurrence of intravasation (P < .05). And the area under the receiver operating characteristic curves of the multifactor-combined prediction model of the intravasation was significantly larger than that of single-factor. CONCLUSIONS: Sonographers and gynecologists should be familiar with the risk factors of intravasation and select the appropriate timing of HyCoSy toward reducing the occurrence of intravasation and other complications after thoroughly explaining and communicating with the patients.

Is Hysterosalpingo-Contrast Sonography (HyCoSy) Using Sulfur Hexafluoride Microbubbles (SonoVue) Sufficient for the Assessment of Fallopian Tube Patency? A Systematic Review and Meta-Analysis.

This study aimed to evaluate the diagnostic value of HyCoSy using sulfur hexafluoride microbubbles for fallopian tubal patency assessment in infertile females. Twenty-four studies, including 1358 females with 2661 detected fallopian tubes published from January 2003 to May 2019, were identified. The pooled sensitivity was 93% (95% CI: 90-95%), while the specificity was 90% (95% CI: 87-92%). The area under the receiver-operating characteristic curve was 0.96 (95% CI: 94-98%). The specificity of the four-dimensional HyCoSy subgroup was higher than the 2D/3D subgroup; an increased dose of contrast agent did not affect the specificity, with only a slightly reduced sensitivity.

Comparison of Effectiveness as well as Advantages and Disadvantages of Different Dimensions of Hysterosalpingo-Contrast Sonography for Diagnosis of Lesions Associated with Female Infertility.

Methods: Forty subjects who underwent routine two-dimensional (2D) vaginal ultrasound, three-dimensional HyCoSy (3D-HyCoSy), and four-dimensional HyCoSy (4D-HyCoSy) examinations from January 2021 to July 2022 at the ultrasound department of Pukou Branch of Jiangsu Province Hospital were enrolled to this study. Fallopian tubal recanalization by hydrotubation (FTRH) was used as the gold standard to compare the efficacy of 2D vaginal ultrasound, 3D-HyCoSy, and 4D-HyCoSy in assessing the subjects for the presence of polyps, myomas, and other occupants in the uterine cavity or uterine adhesions. Results: A total of 18 cases of uterine cavity lesions, 11 of pelvic lesions, and 11 of ovarian lesions were identified by FTRH, while 80 fallopian tubes were found in 40 patients and 71 tubal obstructions were detected by FTRH. Vaginal ultrasound assessment of uterine cavity, pelvis, ovarian lesions, and tubal obstruction was moderately consistent with FTRH (Kappa = 0.616, 0.673, 0.654, and 0.640), 3D-HyCoSy was in good agreement with FTRH (Kappa = 0.812, 0.910, 0.906, and 0.894), and 4D-HyCoSy was in good agreement with FTRH (Kappa = 0.914, 0.903, 1.000, and 0.942), with 4D-HyCoSy being in good agreement with FTRH had the highest agreement. Conclusion: 4D-HyCoSy can be used as an effective tool for clinical diagnosis of female tubal obstruction infertility and provide a reference basis for the design of subsequent clinical treatment plans.

Hysterosalpingography is obsolete: hysterosalpingo-contrast foam sonography should be the alternative.

Current evidence suggests that the hysterosalpingo-foam sonography test (HyFoSy) has emerged as a new option to make Fallopian tube assessment easier. Several published studies have compared the different types of tubal patency test available with the accepted gold standard, laparoscopy and dye, endorsing the advantages of HyFoSy over the other techniques. However, the authors wonder why professionals nowadays do not indicate HyFoSy as a first-choice diagnostic tool, with X-ray hysterosalpingography as still the most recommended procedure in outpatients. The aim of this article is to highlight the latest updates on this topic in order to raise awareness of the benefits of hysterosalpingo-contrast sonography as well as provide some tips for performing HyFoSy to obtain the maximum information in a single consultation.

Lipiodol flushing under ultrasound guidance at time of hystero-salpingo contrast sonography (HyCoSy): A retrospective observational study.

BACKGROUND: Up to 30% of female infertility can be attributed to tubal abnormalities. Assessment of fallopian tube patency forms a component of the basic assessment of infertility. Tubal patency can be checked through hysterosalpingogram (HSG) under radiologic guidance with oil- or water-based contrast medium (OBCM or WBCM), or hystero-salpingo contrast sonography (HyCoSy) under ultrasound guidance with WBCM. Tubal flushing with OBCM has been shown to improve fertility rates. OBJECTIVES: To study the feasibility and tolerability of performing Lipiodol (ethiodised oil) flush concurrently with HyCoSy. To examine the in vivo sonographic visibility of Lipiodol vs normal saline. MATERIALS AND METHODS: Retrospective observational study of patients with subfertility referred for Lipiodol flushing under ultrasound guidance between August 2017-September 2020 at six private ultrasound practices in Sydney, Australia. RESULTS: There were 412 patients who were referred for Lipiodol flushing. Of these, 86 patients did not have concurrent Lipiodol flush at HyCoSy performed due to strict exclusion criteria. Of the 326 patients who proceeded with Lipiodol flushing at HyCoSy, all cases were successful, with no cases of extravasation. There were no major complications. In vivo sonographic visualisation of Lipiodol was similar to that of the commonly used agitated 0.9% saline (n = 20; mean visibility score 4.3 ± 0.9 vs 4.0 ± 1.2). CONCLUSION: Our study has shown that Lipiodol flushing at time of HyCoSy as a single procedure is feasible and tolerable to patients. Flushing with Lipioidol during HyCoSy is likely as sonographically visible as 0.9% saline.

Effects of hysterosalpingo-contrast sonography examination on endometrial receptivity among women with unexplained infertility.

PURPOSE: Hysterosalpingo-contrast sonography (HyCoSy) is the preferred method for evaluating fallopian tubal patency, and it is associated with improved rates of natural pregnancy among infertile patients. However, the mechanism underlying the improvement in pregnancy rates following HyCoSy remains unclear. This study aimed to investigate the effect of HyCoSy examination on endometrial receptivity as well as pregnancy rates among infertile women. METHODS: This prospective study included 120 women with unexplained infertility who visited our department between June 2018 and February 2021. These patients were classified into the study group (n = 60) and the control group (n = 60) depending on their willingness to undergo three-dimensional HyCoSy in the present cycle (study group) or 6 months later (control group). Endometrial characteristics, including endometrial thickness and pattern as well as the endometrial blood flow distribution pattern, were measured twice by transvaginal Doppler ultrasonography in the preovulatory phase before and after HyCoSy examination. Participants were followed for 6 months to observe the outcome of spontaneous conception. RESULTS: Compared with the control group, the study group had a significantly higher cumulative pregnancy rate at 6 months after HyCoSy (21.6% [13/60] vs 5.0% [3/60], P = 0.007). More patients in the study group showed improved endometrial blood flow distribution (P = 0.021, χ2 = 7.699), but no differences in endometrial thickness and pattern were observed between the groups (P > 0.05). CONCLUSION: HyCoSy examination may improve endometrial perfusion and has a therapeutic effect on improving spontaneous pregnancy among women with unexplained infertility.

Evaluation of the safety and effectiveness of tubal inflammatory drugs in patients with incomplete tubal obstruction after four-dimensional hysterosalpingo-contrast-sonography examination.

BACKGROUND: To investigate the safety and effectiveness of tubal inflammatory drugs in patients with incomplete tubal obstruction of at least one side after four-dimensional hysterosalpingo-contrast-sonography (4D-HyCoSy) examination. METHODS: Two hundred fifteen cases of tubal incomplete obstruction were diagnosed by ultrasonography from February 2019 to November 2020.According to retrospective analysis,the patients in this study were divided into experimental and control groups; the experimental group combined with salpingitis drugs, and the control group received blank control. Basic information, degree of pain, postoperative complications, and pregnancy rate were then compared between the two groups. RESULTS: Compared with the control group, there was no significant difference in the basic information; in preoperative, intraoperative, or postoperative pain; or in postoperative complications (P > 0.05). The cumulative pregnancy rate of the experimental group (26.8%) was statistically different from that of the control group (14.4%) (P < 0.05). CONCLUSIONS: We observed that for infertile patients with incomplete obstruction of at least one fallopian tube as diagnosed by contrast-enhanced ultrasonography, salpingitis-treatment drugs effectively improved the pregnancy rate postoperatively, with high effectiveness and safety. This regimen is thus worthy of further investigation and promotion in the future.

Spontaneous pregnancy rates in infertile women after sequential hydrosonography and hysterosalpingo-foam sonography.

OBJECTIVE: To determine the clinical pregnancy rate following sequential hydrosonography and hysterosalpingo-foam sonography (HyFoSy) in tubal patency assessment among women undergoing infertility work-up. STUDY DESIGN: Prospective follow-up of women referred to our department between July 2019 and October 2020. Sequential hydrosonography and HyFoSy were carried out. RESULTS: Out of 250 having the procedure, 100 women were excluded from study due to limited infertility, semen abnormal or not examined, evaluation for social egg freezing or they were single. Of the remaining 150 women, 48 (32%) conceived during a 10-24 months follow-up period: 17 (11%) conceived naturally and 7 (4.7%) by IUI. The mean time to conception was 5.5 ± 5.4 months and the pregnancy rate was 52% within 6 months. Among the spontaneous pregnancies 47% occurred within a month and 76% within 3 months. CONCLUSION: Sequential hydrosonography and HyFoSy is a promising method for assessing the uterine cavity and tubal patency in women undergoing infertility workup. The findings suggest that the procedure may increase the chance of a spontaneous pregnancy following the procedure. Given the other known advantages of sequential hydrosonography and HyFoSy, this test is worth including in the initial workup for infertile patients.

Comparation of magnetic resonance hysterosalpingography and hysterosalpingosonography for the assessment of fallopian tubal occlusion of female infertility: A protocol for systematic review and meta-analysis.

OBJECTIVE: To evaluate the diagnostic performance of magnetic resonance hysterosalpingography (MR-HSG) for fallopian tubal occlusion in the context of female infertility when compared to the diagnostic performance of hysterosalpingosonography in evaluation of fallopian tubal occlusion of female infertility. METHODS: We will search PubMed, Web of Science, Cochrane Library, and Chinese biomedical databases from their inceptions to the October 31, 2021, without language restrictions. Two authors will independently carry out searching literature records, scanning titles and abstracts, full texts, collecting data, and assessing risk of bias. Review Manager 5.2 and Stata14.0 software will be used for data analysis. RESULTS: This systematic review will investigate whether MR-HSG has more diagnostic value than hysterosalpingosonography in evaluation of fallopian tubal occlusion of female infertility. CONCLUSION: Our meta-analysis indicated MR-HSG may serve as an alternative for further evaluation of fallopian tubal occlusion of female infertility. SYSTEMATIC REVIEW REGISTRATION: INPLASY2021110050.

Two-dimensional hysterosalpingo-contrast-sonography compared to three/four-dimensional hysterosalpingo-contrast-sonography for the assessment of tubal occlusion in women with infertility/subfertility: a systematic review with meta-analysis.

In this meta-analysis, we aimed to compare the diagnostic accuracy of 2D- and 3D/4D-HyCoSy for the assessment of tubal occlusion in women with infertility, using a laparoscopic tubal chromoperturbation dye test as the reference standard. Studies assessing 2D- and 3D/4D-HyCoSy for the assessment of tubal occlusion in women with infertility were searched from January 1990 to April 2019 using Medline and Web of Science databases by three of the authors, using the terms: 'hysterosalpingo-contrast-sonography', 'sonohysterosalpingography', 'HyCoSy', 'HyFoSy', 'three-dimensional', 'four-dimensional', 'ultrasound', 'tubal patency' and 'tubal occlusion'. Data quality was determined using the QUADAS-2 tool. Thirty articles were included; twenty-one studies used 2D-HyCoSy to assess tubal occlusion, six used 3D/4D-HyCoSy, one study used both techniques but in a different set of patients and two used both techniques in the same patients. The risk of bias for most studies was low as determined by QUADAS-2, except for the patient selection domain. Overall, pooled estimated sensitivity and specificity of 2D-HyCoSy were 86% (95% CI = 80%-91%) and 94% (95% CI = 90%-96%), respectively. The corresponding figures for 3D/4D HyCoSy were 95% (95% CI = 89%-98%) and 89% (95% CI = 82%-94%). High heterogeneity was found for both sensitivity and specificity. No statistically significant differences were found between the methods (p = 0.13). We concluded that 2D-HyCoSy has a similar diagnostic performance to 3D/4D-HyCoSy.

Hystero-salpingo scintigraphy for fallopian tubal patency assessment: results from a prospective study.

OBJECTIVE: To evaluate the diagnostic accuracy of a bygone method, hystero-salpingo-scintigraphy (HSSG), for tubal patency assessment of infertile women. MATERIAL AND METHODS: Prospective cohort study involving women in the infertility workup at the University of Debrecen, Hungary. Seventy infertile patients were scheduled to either basic dynamic HSSG, post-purge dynamic HSSG, or post-purge dynamic HSSG followed by SPECT/CT for reducing tracer contamination. The primary endpoint was the evaluation of the diagnostic accuracy of HSSG for the three methods. RESULTS: During the basic dynamic group, the examination yielded a sensitivity of 87.5%, with a specificity of 71.7%, while positive and negative predictive values were 31.8%, and 97.4% respectively. Using post purge dynamic HSSG, it resulted in a sensitivity of 87.5%, a specificity of 88.7%, a positive predictive value of 53.8%, and a negative predictive value of 97.9%. Adding SPECT/CT to post-purge dynamic HSSG increased diagnostic accuracy with 100% sensitivity and 88.7% specificity, while positive and negative predictive values were 57.1% and 100%, respectively. CONCLUSION: HSSG is a non-invasive and well-tolerated technique for tubal patency. It could be used initially to predict tubal patency in case of infertility. Its diagnostic accuracy is higher when it is carried out by adding SPECT/CT to the post-purge dynamic method.

Falloposcopic tuboplasty: an easy, quick, and safe technique.

OBJECTIVE: To describe our simplified technique for falloposcopic tuboplasty (FT) and demonstrate its principle and results. DESIGN: A step-by-step description of the technique and demonstration of its principle using a clay model. SETTING: Private infertility clinics in Osaka and Tokyo operated by 10 physicians. PATIENT(S): A total of 431 infertile women with a diagnosis of unilateral or bilateral proximal tubal occlusion (6 cm from the uterotubal ostia), between October 2013 and February 2019 were included. These patients underwent routine work-ups for infertility, including a semen analysis, hysterosalpingography, antimüllerian hormone, basal luteinizing hormone/follicle-stimulating hormone and prolactin concentrations during menstruation, postcoital test in the periovulatory period, and estradiol and progesterone concentrations in the middle of the luteal phase. Physicians performed hysterosalpingography to evaluate tubal patency and uterine shape. Saline infusion sonography was not conducted because it does not accurately identify regions of tubal occlusion and/or stenosis. INTERVENTION(S): The principle of our simplified technique for FT is that a hole is located at the side of the FT catheter tip. Therefore, the balloon and fiberscope move away from the catheter line (Fig. 1). The uterotubal ostium is located at the tip-end of the triangle of the uterine cavity. When a balloon is inserted while visualizing the uterotubal ostium at the nearest position to the ostium, the balloon hits the uterine wall. When a balloon is inserted 5-10 mm from the uterotubal ostium without visualization, the balloon may be easily placed in the ostium through its convex angle, allowing it to slide into the uterine wall (Figs. 2 and 3). Step 1: Confirm anteflexion or retroflexion of the uterus by ultrasound. Step 2: Confirm the direction of the uterotubal ostia by hysteroscopy. Step 3: Adjust the angle of the FT catheter according to steps 1 and 2, insert the catheter into the end of the uterus, pull it back 5-10 mm (without visualizing the uterotubal ostia), and then fix it to the forceps. Catheter placement away from the tubal ostium is confirmed by the residual length of the moving part of the catheter. An attending instructor should ask the operator about the feeling of rigidity when the catheter does not advance and then suggest whether to proceed or stop. In the latter case, the catheter is not moved, saline is infused for 1 minute for lubrication, the balloon is pulled back using the fiberscope to remove the bunching of the balloon, and balloon pressure is changed as follows: 6→8→6→10→6 mmHg. Our institutional review board stated that approval was not required because the video describes the technique of our routine procedure. MAIN OUTCOME MEASURE(S): A description of the FT technique using a clay model and a demonstration of its application in our clinic. RESULT(S): The average operative time was 15.4 minutes, and the clinical pregnancy rate was 24.4% (natural conception and intrauterine insemination without in vitro fertilization). No significant differences were observed in the operative time or pregnancy rate among physicians. Approximately 17 FT procedures may be performed using one fiberscope. CONCLUSION(S): Our simplified technique, which was described and demonstrated in this video article, is a feasible and practical approach for performing FT. It provides excellent cost performance by saving fiberscopes. The most important point is "Introduce the balloon and fiberscope 5-10 mm away from the uterotubal ostia without visualizing it." To facilitate learning this technique, we recommend watching the video and then practicing FT without searching for the uterotubal ostia. Physicians master FT without any assistance by an attending instructor in ≤3 attempts.

Transvaginal hydrolaparoscopy versus hysterosalpingography in the work-up for subfertility: a randomized controlled trial.

RESEARCH QUESTION: Is transvaginal hydrolaparoscopy (THL) non-inferior to hysterosalpingography (HSG) as a first-line tubal patency test in subfertile women in predicting the chance of conception leading to live birth? DESIGN: A multicentre, randomized controlled trial in four teaching hospitals in the Netherlands, which randomized subfertile women scheduled for tubal patency testing to either THL or HSG as a first-line tubal patency test. The primary outcome was conception leading to live birth within 24 months after randomization. RESULTS: A total of 149 women were randomized to THL and 151 to HSG. From the intention-to-treat population, 83 women from the THL group (58.5%) conceived and delivered a live born child within 24 months after randomization compared with 82 women (55.4%) in the HSG group (difference 3.0%, 95% CI -8.3 to 14.4). Time to conception leading to live birth was not statistically different between groups. Miscarriage occurred in 16 (11.3%) women in the THL group, versus 20 (13.5%) women in the HSG group (RR = 0.66, 95% CI 0.34 to 1.32, P = 0.237), and multiple pregnancies occurred in 12 (8.4%) women in the THL group compared with 19 (12.8%) women in the HSG group (RR = 0.84, 95% CI 0.46 to 1.55, P = 0.58). Ectopic pregnancy was diagnosed in two women in the HSG group (1.4%) and none in the THL group (P = 0.499). CONCLUSION: In a preselected group of subfertile women with a low risk of tubal pathology, use of THL was not inferior to HSG as a first-line test for predicting conception leading to live birth.

Feasibility, tolerability, and safety of hysterosalpingo-foam sonography (hyfosy). multicenter, prospective Spanish study.

OBJECTIVE: To determine the feasibility,tolerability, and safety of the ultrasound assessment of tubal patency using foam as contrast. METHODS: This was a prospective multicenter study of 915 infertile nulliparous women scheduled for sonohysterosalpingography with foam instillation (HYFOSY) for tubal patency testing as a part of the fertility workup. Clinical and sonographic data were recorded into a web-shared database. Tubal patency, cervical catheterization, pain during the procedure and post-procedural complications were collected. Patients reported discomfort or pain experienced during the procedure with a visual analogue scale (VAS) score. RESULTS: Nine hundred fifteen women were included in the final analysis. Median age was 34 (range, 21-45) years and median body mass index was 23 (range, 16-41) kg/m2. Of 839 women, only 8(0.95 %) cases were abandoned due to impossibility of introducing the intracervical catheter. Most of the cervical os were easily cannulated with either paediatric nasogastric probes or special catheter for intrauterine insemination / sonohysterosalpingography 688/914(75.3 %). With a median instillation of 4 mL (range 1-16) of foam, both tubes were identified in 649/875 (70.9 %) patients, while unilateral patency was observed in 190/875 (20.8 %). Only 36/875 (3.9 %) of the women had bilateral tubal obstruction. The median VAS score for perception of pain during HyFoSy examination was 2 (range 0-10), and only 17 (1.9 %) of women reported severe pain (VAS ≥ 7). Pain was unrelated to tubal patency or tubal blockage. Unexpectedly, difficult cervical catheterizations that needed tenaculum, were more likely associated with mild pain during procedure [nasogastric probe group 176/289 (70.9 %) vs. insemination catheter group 166/399 (41.6 %) vs. tenaculum group 190/218(87.2 %) p < 0.001]. Finally, among 915 patients, we only noticed 3 (0.32 %) complications of the technique: two vasovagal episodes and a mild urinary infection. CONCLUSION: HYFOSY is a feasible, well-tolerated and safe technique for the evaluation of tubal patency in infertile women.

Tubal Flushing Treatment for Unexplained Infertility.

Tubal patency testing was initially introduced as a diagnostic test. However, it has been observed that some tubal patency tests also have a therapeutic effect. This therapeutic effect can be influenced by the contrast medium used during tubal flushing. In this review, we discuss current evidence associated with different methods for tubal flushing and their potential impact on reproductive outcomes in women with unexplained infertility. Furthermore, we discuss their diagnostic accuracy, safety, and cost-effectiveness.

Assessment of female fertility in the general practice setting.

BACKGROUND: An assessment of female fertility may be undertaken in the general practice setting for a variety of reasons. These include concerns about future fertility when pregnancy is not immediately planned, a desire to consider elective oocyte cryopreservation and difficulty conceiving. OBJECTIVE: The aim of this article is to summarise indications, rationale and components of a comprehensive female fertility assessment in a primary care setting. DISCUSSION: The primary care physician has an essential role in providing women with guidance, counselling and assessment regarding fertility concerns. A complete initial assessment includes pre-pregnancy screening and counselling, and assessment of ovulation, ovarian reserve and pelvic anatomy to guide further investigation and management.

Does hysterosalpingo-foam sonography have any therapeutic effect? A systematic review.

INTRODUCTION: Tubal patency is one of the mandatory and necessary conditions to be granted in order to guarantee a good pregnancy rate. Numerous studies have been conducted to compare the various testing techniques for tubal evaluation in order to optimize the diagnostic-therapeutic process. Aim of this review is to clarify if hysterosalpingo-foam sonography could be considered as a useful tool not only in the diagnostic procedure, but also in treatment of infertility. EVIDENCE ACQUISITION: We performed a comprehensive search of relevant studies from January 2010 to December 2019 to ensure all possible studies were captured. A systematic search of PubMed databases was conducted. EVIDENCE SYNTHESIS: Over the years, increasingly less invasive approaches have been used to test tubal patency. For many years Laparoscopic with chromopertubation (DLS) has been considered the reference standard, then less invasive procedures have been introduced, such as hysterosalpingography (HSG). Sonohysterosalpingography (HyCoSy) represents a non-invasive procedure with accuracy comparable to HSG. Several studies have been made on different contrast agents that could be used on this procedure and recent studies considered hysterosalpingo-foam sonography (HyFoSy) procedure as a new technique used for the study of tubal function performed on unfertile women. Nowadays, HyFoSy is largely used in the study of tubal patency, but it is not completely clear the role of this technique as treatment of imperviousness of Fallopian tubes, leading to an increase in pregnancy rate after its use. CONCLUSIONS: As described in the literature for other procedures, similarly with HyFoSy, the tubal flushing improves the chance of an embryo implanting and establishing a spontaneous pregnancy. More prospective studies should be taken to better analyze the singular maternal risk fators, hoping to offer more complete indications to recommend HyFoSy.

Hysterosalpingo-contrast-sonography vs. magnetic resonance-hysterosalpingography for diagnosing fallopian tubal patency: A systematic review and meta-analysis.

PURPOSE: To compare hysterosalpingo-contrast-sonography (HyCoSy) and magnetic resonance-hysterosalpingography (MR-HSG) in the diagnosis of fallopian tubal patency. MATERIALS AND METHODS: The databases of PubMed, Embase, and the Cochrane Library were searched for records up to November 30, 2019. Studies involved in the diagnostic detection of HyCoSy or MR-HSG for fallopian tubal patency using conventional HSG or laparoscopy as the reference test were included. Data was analyzed by meta-analysis. We compared sensitivity, specificity, positive and negative likelihood ratios (PLR and NLR), diagnostic odds ratio (DOR), and summary receiver operating characteristic (sROC) plots of both HyCoSy and MR-HSG. Quality was assessed using the QUADAS-2 tool. RESULTS: The analysis included 24 articles involving 1340 patients. HyCoSy was studied in 17 studies, and MR-HSG was studied in seven studies. For HyCoSy in diagnosis of fallopian tubal patency, pooled sensitivity was 89 % (95 % confidence interval [CI], 87 %-91 %), and specificity was 93 % (95 % CI, 91 %-94 %). For MR-HSG in diagnosis of fallopian tubal patency, pooled sensitivity was 100 % (95 % CI, 98 %-100 %), and specificity was 82 % (95 % CI, 74 %-89 %). The sROC showed similar diagnostic accuracy for MR-HSG and HyCoSy. 3D/4D HyCoSy with ultrasound microbubbles had equal sensitivity (95 % vs. 100 %, P = 0.186) and significantly higher specificity (94 % vs. 82 %, P = 0.005) compared with MR-HSG. CONCLUSIONS: HyCoSy and MR-HSG showed similar overall diagnostic performance for diagnosing fallopian tubal patency. 3D/4D HyCoSy with ultrasound microbubbles could significantly improve the diagnostic specificity of HyCoSy.