Hysterosalpingo-foam Sonography Research Articles

The effect of prior hysterosalpingo-foam sonography or hysterosalpingography on tubal patency: a secondary analysis of a randomized controlled trial.

Does hysterosalpingo-foam sonography (HyFoSy) prior to hysterosalpingography (HSG) or HSG prior to HyFoSy affect visible tubal patency when compared HSG or HyFoSy alone? Undergoing either HyFoSy or HSG prior to tubal patency testing by the alternative method does not demonstrate a significant difference in visible tubal patency when compared to HyFoSy or HSG alone. HyFoSy and HSG are two commonly used visual tubal patency tests with a high and comparable diagnostic accuracy for evaluating tubal patency. These tests may also improve fertility, although the underlying mechanism is still not fully understood. One of the hypotheses points to a dislodgment of mucus plugs that may have disrupted the patency of the Fallopian tubes. This is a secondary analysis of the randomized controlled FOAM study, in which women underwent tubal patency testing by HyFoSy and HSG, randomized for order of the procedure. Participants either had HyFoSy first and then HSG, or vice versa. Here, we evaluate the relative effectiveness of tubal patency testing by HyFoSy or HSG prior to the alternative tubal patency testing method on visible tubal patency, compared to each method alone. Infertile women aged between 18 and 41 years scheduled for tubal patency testing were eligible for participating in the FOAM study. Women with anovulatory cycles, endometriosis, or with a partner with male infertility were excluded. To evaluate the effect HyFoSy on tubal patency, we relied on HSG results by comparing the proportion of women with bilateral tubal patency visible on HSG in those who underwent and who did not undergo HyFoSy prior to their HSG (HyFoSy prior to HSG versus HSG alone). To evaluate the effect of HSG on tubal patency, we relied on HyFoSy results by comparing the proportion of women with bilateral tubal patency visible on HyFoSy in those who underwent and who did not undergo HSG prior to their HyFoSy (HSG prior to HyFoSy versus HyFoSy alone). Between May 2015 and January 2019, we randomized 1160 women (576 underwent HyFoSy first followed by HSG, and 584 underwent HSG first followed by HyFoSy). Among the women randomized to HyFoSy prior to HSG, bilateral tubal patency was visible on HSG in 467/537 (87%) women, compared with 472/544 (87%) women who underwent HSG alone (risk difference 0.2%; 95% CI: -3.8% to 4.2%). Among the women randomized to HSG prior to HyFoSy, bilateral tubal patency was visible on HyFoSy in 394/471 (84%) women, compared with 428/486 (88%) women who underwent HyFoSy alone (risk difference -4.4%; 95% CI: -8.8% to 0.0%). The results of this secondary analysis should be interpreted as exploratory and cannot be regarded as definitive evidence. Furthermore, it has to be noted that pregnancy outcomes were not considered in this analysis. Tubal patency testing by either HyFoSy or HSG, prior to the alternative tubal patency testing method does not significantly affect visible tubal patency, when compared to alternative method alone. This suggests that both methods may have comparable abilities to dislodge mucus plugs in the Fallopian tubes. The FOAM study 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, or interpretation of the data. H.R.V. reports consultancy fees from Ferring. M.v.W. received a travel grant from Oxford University Press in the role of Deputy Editor for Human Reproduction and participates in a Data Safety and Monitoring Board as an independent methodologist in obstetrics studies in which she has no other role. M.v.W. is coordinating editor of Cochrane Fertility and Gynaecology. B.W.J.M. received an investigator grant from NHMRC (GNT1176437) and research funding from Merck KGaA. B.W.J.M. reports consultancy for Organon and Merck KGaA, and travel support from Merck KGaA. B.W.J.M. reports holding stocks of ObsEva. V.M. received research grants from Guerbet, Merck and Ferring and travel and speaker fees from Guerbet. The other authors do not report conflicts of interest. International Clinical Trials Registry Platform No. NTR4746.

Diagnostic accuracy of hysterosalpingo-foam sonography for assessment of fallopian tube patency in infertile women

Research questionWhat is the diagnostic accuracy of hysterosalpingo-foam sonography (HyFoSy), using two-dimensional ultrasound in tubal patency assessment in infertile women compared with laparoscopy with dye chromotubation? DesignThis prospective study was conducted at My Duc Hospital, Vietnam. Infertile women aged 18 years or older, who were scheduled for laparoscopy, were included. Visual Analogue Scale (VAS) score for perception of pain during HyFoSy was used. Laparoscopy was carried out on the same day. Clinicians undertaking laparoscopy were blinded to HyFoSy results. Sensitivity, specificity, negative and positive predictive value, and 95% confidence intervals were calculated. A sample size of 455 women (n = 910 fallopian tubes) was needed to demonstrate a fluctuation hypothesis, not exceeding 6%, for sensitivity and specificity (power 0.80, two-sided alpha 5%, loss to follow-up 5%). ResultsBetween 2019 and 2022, 455 participants were recruited. Hysterosalpingo-foam sonography was unsuccessfully carried out in six participants. Two withdrew their consent. Data analysis was conducted on the remaining 447 participants (n = 868 fallopian tubes). The sensitivity and specificity of hysterosalpingo-foam sonography compared with laparoscopy were 0.75 (95% CI 0.71 to 0.79) and 0.70 (95% CI 0.65 to 0.74), respectively. Hysterosalpingo-foam sonography gave a positive predictive value of 0.76 (95% CI 0.73 to 0.80) and negative predictive value of 0.68 (95% CI 0.64 to 0.73). A total of 42.8% of women reported a VAS score of no pain. No adverse event was reported. ConclusionCompared with laparoscopy with dye chromotubation, two-dimensional HyFoSy is a well-tolerated, reliable technique for assessing tubal patency.

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

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? 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. 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. 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. 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. 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. 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. 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. 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. International Clinical Trials Registry Platform No. NTR4746.

An Ultrasound-Based Preoperative Evaluation of the Endometriosis Fertility Index: A Further Step towards Personalized Treatment.

Background: The Endometriosis Fertility Index (EFI), is a crucial validated surgical tool used for predicting fertility outcomes in women with endometriosis. This study aims to assess the concordance between a preoperative clinical and instrumental EFI evaluation (uEFI) and the EFI score obtained during an exploratory laparoscopy prior to surgery (sEFI). Methods: This study presents preliminary data from a broader observational cohort study. The Least Function score for the uEFI was calculated using a modified version of the original surgical EFI by incorporating a clinical examination, advanced ultrasound, and hysterosalpingo-foam sonography (HyFoSy). Results: The preoperative estimation of the EFI (uEFI) demonstrated a high concordance (k = 0.695, ρs = 0.811) with the sEFI. Remarkably, the surgical interventions led to a significant improvement in the EFI values, with 80% of the intermediate EFI transitioning to a high level, thereby highlighting the positive impact of surgery on fertility outcomes. Conclusion: This study highlights the accuracy of preoperative EFI estimation (uEFI) and its strong agreement with intraoperative assessment. It underscores the potential of a preoperative management tool to guide the allocation of infertile women with endometriosis to operative laparoscopy, direct assisted reproductive technology (ART), or spontaneous attempts at pregnancy.

Sequential-contingent strategy for fallopian tube evaluation using hysterosalpingo foam sonography: a cost analysis.

Tubal pathology is the etiological factor in 20% of couples with female infertility. Historically, diagnostic evaluation of the fallopian tubes has been performed by means of hysterosalpingography (HSG). Hysterosonosalpingography with EXEM® foam is a recent technique with supposedly comparable effectiveness to HSG, but with better tolerability for patients. Tubal patency was assessed in patients who were candidates for intrauterine insemination (IUI) between January 2020 and July 2021. (I) Hysterosonosalpingography with EXEM® foam. (II) If the patient had both tubes patent, IUI was proposed. In case of inconclusive or pathological results, HSG was performed. (III) If the HSG concludes tubal patency, IUI is proposed. On the other hand, if it results in tubal obstruction, in vitro fertilization (IVF) is proposed. Assessment of tubal patency by HSG showed concordance with previous Hysterosonosalpingography with EXEM® foam results in 45.5% (n=15) of cases of unilateral obstruction and 66.7% (n=6) of cases of bilateral obstruction. When we compare the total cost of HSG (€54,899.46) with the sum of patients who only required Hysterosonosalpingography with EXEM® foam together with those who underwent both tests (€45,575.96), it shows that the latter represents a cost benefit strategy (cost difference €9,323.50). Our results suggest a benefit of €9,323.50 when performing the contingent sequential strategy, in case of pathological or inconclusive results, compared to performing a systematic HSG in all patients. Patients with an obstructive hysterosalpingogram with EXEM® and a patent hysterosalpingogram will be the subgroup that will benefit the most, as IUI can be proposed instead of IVF. In addition, there is a benefit in terms of optimizing the medical procedure, hospital visits and speeding up the time to start assisted reproductive technology (ART).

#240 : Diagnostic Accuracy of Hysterosalpingo-Foam Sonography (HyFoSy) for Fallopian Tube Patency Assessment in Infertile Women

Background and Aims: Tubal patency assessment is an important part of routine infertility work-up. It has been suggested that hysterosalpingography should no longer be considered as a ‘first line’ diagnostic procedure. We aimto determine the accuracy of an alternative technique, hysterosalpingo-foam sonography (HyFoSy), in tubal patency assessment in infertile women. Methods: This prospective study was conducted at My Duc Hospital and was approved by the institutional ethics committee (25/2019/MD). Infertile women who were scheduled for undegoing laparoscopy during infertility investigation. A visual analogue scale (VAS) score for perception of pain during HyFoSy was used. Laparoscopywith dye chromotubation, was performed on the same day and used as a gold standard. Clinicians performing laparoscopy were blinded to HyFoSy results. Sensitivity, specificity, negative and positive predictive value (NPV, PPV)and 95% confidence interval (CI) were calculated. A sample size of 455 women was needed to demonstrate a non-exceeding 8% of fluctuation hypothesis of the two sensitivity and specificity (power 0.80, two-sided alpha 5%, loss to follow-up 5%). Results: Between 2019 and 2022, we recruited 455 women. Five women had inconclusive HyFoSy results, three women withdrew consents. Data analysis was performed on 447 women (868 tubes). The sensitivity and specificity of HyFoSy, as compared to laparoscopy, were 0.76 (95% CI 0.72–0.80) and 0.71 (95% CI 0.67–0.75), respectively. HyFoSy gave a PPV of 0.72 (95% CI 0.69–0.76) and a NPV of 0.75 (95% CI 0.72–0.78). 50% of women reported no pain. No adverse events were reported. Conclusion: HyFoSy is a well-tolerated, safe, and reliable technique compared to laparoscopy for tubal patency assessment.

O-192 Does tubal flushing by hysterosalpingo-foam sonography and hysterosalpingography affect tubal patency? Results from a randomized clinical trial

Abstract Study question Does tubal flushing by hysterosalpingo-foam-sonography (HyFoSy) or hysterosalpingography (HSG) affect tubal patency in infertile women? Summary answer Tubal flushing by HyFoSy and HSG does not increase the number of women with visible bilateral tubal patency. What is known already HyFoSy and HSG are two frequently used methods to visualize tubal patency by flushing a contrast fluid through the Fallopian tubes, while the uterus and Fallopian tubes are imaged using respectively fluoroscopy and ultrasound. Tubal flushing by HSG, specifically with oil-based contrast, improves live birth rates in infertile women. The mechanism of this fertility-enhancing effect is still not completely understood. The potential fertility-enhancing effect of other tubal flushing methods, for example HyFoSy, are studied less frequently. Here, we investigated whether tubal flushing affect tubal patency, and therefore could explain the fertility-enhancing effect of tubal flushing. Study design, size, duration This is a secondary analysis of the FOAM-trial, a multi-center RCT in which women were assigned to undergo tubal flushing by HSG and HyFoSy in randomized order. They either had HyFoSy first and then HSG or the other way around. Here, we assess whether tubal flushing by either HSG or HyFoSy led to differences in tubal patency. We also investigate whether the type of contrast used during HSG (oil -and water based) influenced tubal patency. Participants/materials, setting, methods We studied infertile women with indication for tubal patency testing. Women with anovulatory cycles, endometriosis or with a partner with male infertility were excluded. The main outcome was the number of women with bilateral tubal patency. This outcome, was compared in two analyses: 1) Tubal flushing by HyFoSy versus no flushing, with HSG as reference test, and 2) Tubal flushing by HSG (with oil –or water contrast) versus no flushing, with HyFoSy as reference test. Main results and the role of chance Between May 2015 and January 2019, 1,160 women were included. There were 957 women who underwent HyFoSy with interpretable results and 1,081 women who underwent HSG with interpretable results. Tubal flushing by HyFoSy versus no tubal flushing, with HSG done in all women as reference test, evaluating the effect of tubal flushing by HyFoSy, resulted in a comparable number of women with visible bilateral tubal patency: 467/537 (87%) vs. 472/544 (87%) ; (RR 1.00; 95%CI: 0.96-1.05). Tubal flushing by HSG (with both water –and oil-based contrast) versus no tubal flushing, with HyFoSy done in all women as reference test, evaluating the effect of tubal flushing by HSG, did not show an increase of women with visible bilateral tubal patency: 394/471 (84%) vs. 428/486 (88%); RR 0.95; (95%CI:0.90-1.00). Tubal flushing by HSG with oil-based contrast versus no flushing, with HyFoSy as reference test, resulted in a comparable number of women with visible bilateral tubal patency: 283/330 (86%) vs. 271/308 (88%); RR 0.97; (95%CI:0.92-1.04). Tubal flushing by HSG with water-based contrast versus no flushing, with HyFoSy as reference test, did show a decrease of women with visible bilateral tubal patency: 108/137 (79%) vs. 156/171 (91%); RR 0.90 (95%CI:0.83-0.98). Limitations, reasons for caution It needs to be noted that subtle improvements of tubal patency, caused by initial tubal flushing with either HyFoSy or HSG, cannot be detected on respectively ultrasound and fluoroscopy images and were therefore not assessed in this study. Wider implications of the findings The therapeutic effect of tubal flushing cannot be explained by dissolving visible obstruction in the Fallopian tubes. This suggests that the therapeutic effect of tubal flushing mainly applies to women with anatomically normal Fallopian tubes. Trial registration number NTR4746

Diagnostic accuracy of hysterosalpingo-lidocaine-foam sonography combined with power Doppler (HyLiFoSy-PD) compared to laparoscopy and dye testing in tubal patency assessment in cases of infertility

BackgroundTubal patency testing is an essential part of female subfertility evaluation. Hysterosalpingogram is less invasive and less expensive compared to laparoscopy and dye testing (LDT), i.e., laparoscopic chromopertubation. Hysterosalpingo-foam sonography (HyFoSy) uses commercial echogenic gel foam that is easily visible on ultrasound to assess the tubes. It offers a safer and less painful alternative to HSG, with no radiation exposure. Hysterosalpingo-lidocaine-foam sonography with power Doppler (HyLiFoSy-PD) uses lidocaine-made gel foam as a contrast medium. It was postulated to as to be less painful and easier to detect on ultrasound, compared with hysterosalpingo-foam sonography using other contrast media and that it can also be used whenever the commercial gel used with HyFoSy is not available or is relatively expensive.MethodologyThis prospective diagnostic accuracy study was carried out between February 2018 and 2020 at the Cairo Fetal Medicine Unit, Department of Obstetrics and Gynecology, Cairo University. One hundred twenty-two infertile patients, who were already scheduled for LDT as a part of their infertility work-up, were consecutively recruited for this study. The HyLiFoSy-PD (index test) was performed 1 week before the scheduled LDT for these patients. Using an intrauterine pediatric Folley’s balloon catheter, 20 ml of lidocaine-made gel foam was slowly infused intrauterine, while observing their flow in both fallopian tubes using a grayscale and power Doppler transvaginal two-dimensional ultrasound system. All patients then underwent LDT (reference test). The results of HyLiFoSy-PD were compared with those of LDT to determine the accuracy of HyLiFoSy-PD in tubal patency assessment. We also assessed the procedure duration, associated pain, and other complications.ResultsComparing HyLiFoSy-PD with LDT in the 115 patients who completed the procedure, results showed 98.1% sensitivity, 90% specificity, 99% positive predictive value, 81.8% negative predictive value, 9.81 positive likelihood ratio, 0.02 negative likelihood ration, and 97.4% overall accuracy in the assessment of tubal patency (odds ratio = 463.5 with confidence interval = 79.39–2706; P-value: 0.687). The median procedure duration was 11 min. All patients experienced some degree of pain during the procedure with 91 patients (79%) reported mild pain and 24 patients (21%) reported moderate pain.ConclusionHyLiFoSy-PD was found to be an accurate tool in tubal patency assessment. It was also found to be safe and well-tolerated.

Technical Tips and Tricks after 10 Years of HyFoSy for Tubal Patency Testing.

Background: Hysterosalpingo-foam sonography (HyFoSy) has gained popularity in the last decades, as it represents a feasible, well-tolerated, and minimally invasive method of evaluation of tubal patency in cases of infertility. The purpose of this study was to communicate the technical tips and tricks based on our experience in performing HyFoSy, with the aim to improve the feasibility, to reduce the pain, and to evaluate pregnancy-obtaining rate after procedure. Methods: Our observational study includes 672 patients from infertile couples who underwent HyFoSy for tubal patency evaluation. During HyFoSy, tubal pathway and patency as well as the level of pain were evaluated. A telephonic questionnaire was conducted in order to assess the pregnancy obtaining rate in the first 3 months and more than 3 months after the procedure. Results: The median age in our group was 33.5 years. Most of our patients (61.16%) underwent HyFoSy in the 8–10 days of the menstrual cycle. Tubal patency was present bilaterally in 86% cases, unilaterally in 11% of patients, and was absent in 3% of cases; 75% of patients related absent or tolerable pain, 17% described HyFoSy as a painful procedure, and 8% experienced extreme pain. After HyFoSy, pregnancy was naturally obtained in 10.86% of cases within the first 3 months after HyFoSy. Conclusions: HyFoSy represents a useful, easy to use, and painless tool in female infertility evaluation and should be considered as a complementary method of the transvaginal ultrasonography, completing the genital tract imaging with information about the hidden part of the standard examination: tubal patency. HyFoSy provides information about patency, caliber regularity, pathway, and occlusion location of the fallopian tubes; therefore, it should be introduced along with transvaginal ultrasound as a first-line infertility exploration method.

Can Hysterosalpingo-Foam Sonography Replace Hysterosalpingography as First-Choice Tubal Patency Test? A Randomized Non-inferiority Trial

(Abstracted from Hum Reprod 2022;37:969–979) A main cause of female infertility is tubal pathology, with 11% to 30% of cases resulting from previous surgery, infections (such as sexually transmitted diseases), or endometriosis. Hysterosalpingography (HSG) is considered as the first choice for a tubal patency test during fertility workup, but the more patient-friendly hysterosalpingo-contrast sonography option has also been introduced.

O-188 Tubal testing with Hysterosalpingo-foam sonography (HyFoSy) versus hysterosalpingography (HSG) during the fertility work-up: a cost-effectiveness analysis alongside a randomised controlled trial

Abstract Study question What are the costs and effects of management based on tubal patency testing by HyFoSy compared to HSG in infertile women during fertility work-up? Summary answer Management based on the results of either HyFoSy or HSG leads to similar pregnancy rates with lower costs for management based on HyFoSy. What is known already Traditionally, tubal patency testing during the fertility work-up is performed by HSG. We recently showed in a randomised controlled trial (RCT) that in infertile women scheduled for tubal patency testing, management based on the results of either HyFoSy or HSG leads to comparable diagnostic accuracy (FOAM trial, van Welie et al, 2022 conditionally accepted). Also, HyFoSy is associated with significantly less pain, it lacks ionizing radiation and exposure to iodinated contrast medium. Moreover, it can be performed by a gynaecologist during a one-stop fertility work-up. Here, we compare the costs and effects of both tubal patency strategies. Study design, size, duration We performed an economic evaluation alongside the FOAM trial, a multi-center cohort study with embedded RCT in the Netherlands. The FOAM trial included 1,160 infertile women (18-41 years) scheduled for tubal patency testing. Women underwent, in a randomised order, both HyFoSy and HSG. The results of both tests were compared and in case of discordant results for HyFoSy or HSG women were randomly allocated to management based on the results of either HyFoSy or HSG. Participants/materials, setting, methods The economic evaluation compared costs of management based on either test within 12 months in the entire study population and in women with discordant results. For the entire study population, we compared two strategies: one that follows the management based on HyFoSy and one based on HSG. We calculated incremental cost-effectiveness ratios (ICERs): the difference in total costs and in 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, we studied 1,160 women, of which 1026 (88%) women underwent both tubal tests and had data available. They were divided in three groups: women with concordant (n = 747, 48% live births), inconclusive (n = 136, 40% live births) or discordant (n = 143, 41% had a live birth after management based on HyFoSy and 49% had a live birth after management based on HSG) results. When these data were integrated in the two strategies, one based on HyFoSy and one based on HSG, the estimated chance of live birth per management strategy was 47% after HSG and 46% after HyFoSy (difference 1.2% (95%CI: -1.5% to 3.4%)). For the procedures itself, HSG costed €266 and HyFoSy €132. When costs of additional fertility treatments were incorporated, the mean total costs per couple were €1,366 for the HSG strategy and €1,250 for the HyFoSy strategy (mean difference €152 (95%CI: €149 to €155). Taking into account the 1.2% increase in live birth rate after the HSG stratey, this leads to an ICER of €10,014 for one additional live birth after HSG compared to HyFoSy. Limitations, reasons for caution The number of inconclusive results for HyFoSy was higher than anticipated. This might be explained by the learning-curve of performing HyFoSy although training was mandatory. Women underwent both tests, therefore the immediate fertility enhancing effect e.g. by using oil-based contrast, could not be determined and is therefore not incorporated. Wider implications of the findings The diagnostic accuracy of HSG and HyFoSy are comparable, while HyFoSy leads to lower costs, is associated with less pain and no ionizing radiation without exposure to iodinated contrast. HyFoSy could replace HSG as first-line tubal patency test, although the direct fertility enhancing effect of both tests should be incorporated. Trial registration number NTR 4746

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.

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

ObjectiveTo determine the clinical pregnancy rate following sequential hydrosonography and hysterosalpingo-foam sonography (HyFoSy) in tubal patency assessment among women undergoing infertility work-up. Study designProspective follow-up of women referred to our department between July 2019 and October 2020. Sequential hydrosonography and HyFoSy were carried out. ResultsOut 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. ConclusionSequential 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.

Is hysterosalpingo-foam sonography (HyFoSy) more tolerable in terms of pain and anxiety than hysterosalpingography (HSG)? A prospective real-world setting multicentre study

BackgroundIn 60% of sterile couples a female factor is present, with these being tubal factors in 30–50% of cases. A tubal patency test is also required in women without a male partner undergoing fertility treatment. Thus, an accurate, safe and tolerable technique should be available. The aim of this study is to determine and to compare hysterosalpingo-foam sonography (HyFoSy) and hysterosalpingography (HSG) tolerability in terms of pain and anxiety.MethodsThis is a prospective real-world setting multicentre study conducted in two tertiary hospitals in Madrid. 210 infertile women/women without a male partner looking to get pregnant were recruited; 111 for the HyFoSy group and 99 for the HSG group. Tolerability was measured in terms of anxiety by the State Trait Anxiety Inventory (STAI) and pain by the Visual Analogue Scale (VAS).ResultsMedian VAS score in HyFoSy group was 2 (P25; P75: 1; 3) versus 5 (4; 8) in HSG group, p < 0.001. The median State-STAI score in the HSG group was 18 points (10; 26) versus 10 (7; 16) in the HyFoSy group (p < 0.001); the median Trait-STAI score in the HSG group was 15 (11; 21) versus 13 (9; 17) in the HyFoSy group (p = 0.044).ConclusionsHyFoSy shows higher tolerability to both: pain and anxiety. It is related to less pain and less post-test anxiety than HSG.

Hysterosalpingo-foam sonography (HyFoSy) in the evaluation of tubal patency

Women’s infertility represents a public health issue as the birth rate in many countries is more and more diminished. At present, there are many investigation procedures for tubal patency with high accuracy that dictate the further management of infertility cases: hysterosalpingography, hysterosalpingo-contrast sonography, chromopertubation testing during laparoscopy (dye test), magnetic resonance-hysterosalpingography. The traditional gold standard in fertility investigation is represented by laparoscopy with chromopertubation testing, which carries the risk of surgical and anesthesia complications, being a procedure performed as inpatient and the costs are elevated. As ultrasonographic techniques advanced, there has been developed hysterosalpingo-foam sonography, a minimally invasive diagnostic procedure, with imperceptible risks or complications, which simultaneously imports valuable information about the uterine cavity and the tubal patency to the sonographer. Our aim in this paper is to present the statistical results existing in the literature concerning the accuracy of hysteronsalpingo-foam sonography (HyFoSy) in relation to the other examination methods, as well as its advantages.

Tubal patency assessment using sequential transvaginal ultrasound and hysterosalpingo-foam sonography after methotrexate treatment for tubal pregnancy

Research questionWhat is the efficacy of sequential two-dimensional transvaginal ultrasound (2D-US) and hysterosalpingo-foam sonography (HyFoSy) after methotrexate (MTX) treatment for tubal pregnancy among patients who desire a future pregnancy? DesignA prospective trial conducted between May 2019 and November 2020. Patients who had a suspected tubal ectopic pregnancy diagnosed by ultrasound and treated by MTX were included. These patients underwent sequential transvaginal 2D-US assessment of the pelvic organs and a complementary HyFoSy for tubal patency. The primary outcome was tubal obstruction in the affected side. ResultsA total of 360 women underwent sequential transvaginal 2D-US assessment of the pelvic organs and a complementary HyFoSy for tubal patency. Of these, 40 (11.1%) women fulfilling the inclusion criteria were enrolled. In six out of 40 (15%), hydrosalpinx of the affected tube was found during the initial transvaginal ultrasound examination and were excluded from further investigation. In the remaining 34 (85%) patients, HyFoSy was carried out. Tubal block was found in 10 out of 34 (29.4%) patients. Of these, eight out of 34 (23.5%) and two out of 34 (5.9%) had a proximal block of the affected tube and bilateral proximal obstruction, respectively. Hysterosalpingography confirmed the tubal obstruction in all the affected cases. No procedure-related complications were documented. ConclusionsForty per cent of women who were treated by MTX for tubal pregnancy were diagnosed with tubal obstruction. We recommend that sequential transvaginal ultrasound and HyFoSy become part of routine follow-up for these women, thus offering them timely referral to the appropriate specialist.

Evaluating Fallopian Tube Patency: What the Radiologist Needs to Know.

Impaired tubal patency accounts for up to 35% of cases of subfertility and infertility. Hysterosalpingography (HSG) or hysterosalpingo-contrast sonography (HyCoSy) represents a first-line test in evaluating fallopian tube patency. Despite the association of HSG with ionizing radiation, HSG is a reference standard in assessing fallopian tube patency and tubal conditions such as tubal occlusion, salpingitis isthmica nodosa, and hydrosalpinx. HSG is widely available and utilizes either a water-soluble contrast medium (WSCM) or an oil-soluble contrast medium (OSCM). Compared with WSCM, HSG with OSCM results in a higher incidence of non-in vitro fertilization pregnancies and, therefore, may be preferred in women younger than 38 years with unexplained subfertility. HSG may also be helpful in assessment after sterilization or before fallopian tube recanalization. US-based tubal tests are free of ionizing radiation and include HyCoSy, with either air-saline or microbubble US contrast material, and hysterosalpingo-foam sonography (HyFoSy), a tubal patency test that utilizes a gel foam. A comprehensive US infertility evaluation of the pelvis and fallopian tubes can be achieved in one setting by adding coronal three-dimensional imaging of the uterus, saline infusion sonohysterography, and HyCoSy or HyFoSy to routine pelvic US. MR HSG and virtual CT HSG also depict tubal patency and uterine and adnexal pathologic conditions and may be considered in select patients. While laparoscopic chromopertubation remains the standard for tubal patency evaluation, its disadvantages are its invasiveness and cost. Knowledge of the different fallopian tube tests and radiologic appearance of normal and abnormal fallopian tubes results in fewer pitfalls, accurate interpretation, and optimal patient care. Online supplemental material is available for this article. ©RSNA, 2021.

Diagnostic Accuracy Study Comparing Hysterosalpingo-Foam Sonography and Hysterosalpingography for Fallopian Tube Patency Assessment.

Introduction: Simplified ultrasound-based infertility protocols that appear to provide enough information to plan effective management have been described. Thus, the objective of this study is to compare the diagnostic accuracy of the hysterosalpingo-foam sonography (HyFoSy) in tubal patency testing with the traditional hysterosalpngography (HSG) for establishing a new diagnostic strategy in infertility. Material and Methods: Prospective observational diagnostic accuracy was performed in a private fertility clinic in which 106 women undergoing a preconceptionally visit were recruited. All of them had low risk for tubal disease, had performed an HSG and were negative for Chlamydia trachomatis antibody. Main outcome measures were tubal patency and pain grade. Results: Evaluation of tubal patency by HyFoSy showed a total concordance with the results of the previous HSG in 72.6% (n = 77), and a total discordance for 4.7% (n = 6), with the inter-test agreement Kappa equal to 0.57, which means moderate concordance. Among the patients, 59.1% did not report pain during the procedure, while the remaining 48.1% indicated pain in different degrees; patients usually report less pain and only 6.6% described more pain with HyFoSy than with HSG (OR 6.57 (CI 95% 3.11–13.89)). Clinical outcomes after performing HyFoSy were not affected. Conclusions: HyFoSy is in concordance with HSG regarding tubal patency results and it is a less painful technique than HSG. HyFoSy is more economical and can be performed in an exam room only equipped with an ultrasound scanner. Based on these results, HyFoSy could be the first-choice diagnostic option to assess tubal patency in patients with low risk of tubal disease.

“One-stop shop” for the evaluation of the infertile patient: hystero-salpingo foam sonography combined with two and three dimensional ultrasound and sonohysterography

Hysterosalpingo-foam sonography (HyFoSy) is considered an acceptable alternative for hysterosalpingography (HSG). By combining HyFoSy with two and three-dimensional (2D and 3D) ultrasound and hysterosonography, a complete fertility work-up can be done. We aimed to evaluate the value of a combined ultrasound examination for fertility work-up. During the study period 113 women were examined. Five of 113 (4.4%) examinations were abandoned due to intra-uterine adhesions that were detected by hysterosonography, and five (4.4%) were abandoned due to technical difficulties. Of 103 women who had completed the examination, 2D ultrasound revealed six patients with hydrosalpinx (5.8%) and sonographic signs of adenomyosis in 13 (12.6%) patients. By combining 2D ultrasound with hysterosonography, two (1.9%) fibroids that were penetrating the uterine cavity and seven (6.8%) endometrial polyps were detected. HyFoSy showed bilateral patent tubes in 58 patients (56.3%), unilateral tubal occlusion in 29 (28.1%) and bilateral tubal occlusion in 16 (15.5%). This study shows that the ‘one-stop shop’ examination is feasible. The combined examination had detected 16 pathological findings that would have not been detected by HyFoSy alone. Hence, it should be offered to couples undergoing routine infertility work-up. IMPACT STATEMENT What is already known on this subject? The accuracy of the HyFoSy alone has been evaluated in different studies, but this presented ultrasound scan is integrating 4 different modalities in one exam (2D scanning of the pelvis, 3D scanning of the uterus, hysterosonography and HyFoSy) and we were able to evaluate the female pelvic organs, including the uterine cavity, the tubes and the ovaries, in order to expand the range of diagnosed pathologies. What do the results of this study add? The concept of ‘one-stop shop’ for the evaluation of female pelvis in couples suffering from infertility is feasible, has comparable accuracy as HSG for tubal occlusion, and higher detection rate for uterine malformations. What are the implications of these findings for clinical practice and/or further research? We suggest to incorporate this examination in routine fertility work-up.

Evaluation of the uterine cavity and fallopian tubes in one step in patients undergoing assisted reproductive technology treatment: Hysterosalpingofoam sonography (hyfosy) in combination with hysteroscopy

Aim: To report on the utilization of hysterosalpingo-foam sonography (HyFoSy) with hysteroscopic evaluation for selected patients undergoing Assisted Reproductive Technology Treatment (ART), whereby we aimed to assess the effectiveness of HyFoSy before hysteroscopy. Material and Method: This retrospective study included 36 infertile women referred to Baskent University’s Ankara Hospital Infertility Clinic in 2017-2019. HyFoSy was applied with hysteroscopy in one step for patients who had not previously been evaluated for tubal patency or who had to be re-evaluated. Results: Two patients were diagnosed with tubal obstruction by HyFoSy and were treated with hysteroscopic tubal catheterization, and tubal patency was obtained after this procedure. HyFoSy was applied in seven patients (19.49%) because their previous hysterosalpingography (HSG) reports were doubtful. Although previous HSG had shown tubal obstruction in three patients, the standard passage of the foam from the fallopian tubes to the abdominal cavity was observed when HyFoSy was applied. Conclusion: The one-step method that we apply in our clinic seems appropriate for both patients and clinicians because it speeds up the evaluation steps of the uterine cavity and fallopian tubes before the next ART attempt.