Safety aspects and side-effects of ExEm-gel and foam for uterine cavity distension and tubal patency testing

Exalto, N.; Stassen, M; Emanuel, Mark Hans

doi:10.1016/j.rbmo.2014.07.015

Cited by 22 publications

(17 citation statements)

References 46 publications

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“…In Dessole’s series,33 the postprocedural infection rate after saline HyCoSy was 0.095%. No infections associated with HyFoSy have been reported in the literature,13,14,18–20,32,36 but this could be due to small sample size of the individual studies performed and insufficient power to detect uncommon complications.…”

Section: Introductionmentioning

confidence: 99%

“…Alternatively, undiluted ExEm ® gel can be used to assess intracavitary abnormalities with less leakage and more optimal and stable distention of the uterine cavity compared to saline 14. There is some evidence that gel infusion sonohysterography may be associated with lower pain scores15,16 and fewer technical failures17 compared to saline infusion sonohysterography with comparable accuracy.…”

Section: Introductionmentioning

confidence: 99%

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Hysterosalpingo-foam sonography: patient selection and perspectives

Rajesh

Lim

2016

IJWH

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We present an overview of the common types of tubal patency tests, with a focus on hysterosalpingo-foam sonography (HyFoSy). Current evidence suggests that HyFoSy is an accurate alternative to X-ray hysterosalpingography (HSG) for outpatient tubal evaluation in women who are at low risk for tubal disease. It may be superior to saline hysterosalpingo-contrast sonography (HyCoSy) in excluding tubal occlusion. A hyperechogenic medium may enhance contrast visualization and enable clearer delineation of tubal anatomy. This may enhance confidence in the diagnosis of tubal patency, reduce false occlusion results, and improve the diagnostic yield of the test. It would be reasonable to deduce that HyFoSy would have similar performance characteristics as HyCoSy with other positive contrast agents. The available evidence supports the accuracy of HyFoSy compared to other forms of tubal investigation. We suggest a decision-making pathway based on the most current professional recommendations and available evidence. However, in this article, we do not provide a definitive exposition of the methods used for investigating tubal patency. Rather, we explore the contexts in which the various investigations are most and least suitable, and identify their strengths and limitations. Finally, we also discuss challenges encountered when performing tubal contrast sonography in clinical practice, including the problem of false occlusion results.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Hysterosalpingo-foam sonography: patient selection and perspectives

Rajesh

Lim

2016

IJWH

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“…In the intervention arm of this randomised trial, we performed a Gel Infusion Sonography (GIS) prior to IVF/ICSI treatment, and in the control arm, we applied a sham procedure. In both arms, we used ExEm-gel ® , a pharmacologically neutral gel, not containing any components which may enhance endometrial receptivity ( Exalto et al , 2007 , 2014 ; Emanuel et al , 2012 ).…”

Section: Introductionmentioning

confidence: 99%

Uterine bathing with sonography gel prior to IVF/ICSI-treatment in patients with endometriosis, a multicentre randomised controlled trial

Lier

Özcan

Schreurs

et al. 2020

Human Reproduction Open

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STUDY QUESTION What is the effect of uterine bathing with sonography gel prior to IVF/ICSI-treatment on live birth rates after fresh embryo transfer in patients with endometriosis? SUMMARY ANSWER After formal interim analysis and premature ending of the trial, no significant difference between uterine bathing using a pharmacologically neutral sonography gel compared to a sham procedure on live birth rate after fresh embryo transfer in endometriosis patients (26.7% vs. 15.4%, relative risk (RR) 1.73, 95% confidence interval (CI) 0.81–3.72; P- value 0.147) could be found, although the trial was underpowered to draw definite conclusions. WHAT IS KNOWN ALREADY Impaired implantation receptivity contributes to reduced clinical pregnancy rates after IVF/ICSI-treatment in endometriosis patients. Previous studies have suggested a favourable effect of tubal flushing with Lipiodol ® on natural conceptions. This benefit might also be explained by enhancing implantation through endometrial immunomodulation. Although recent studies showed no beneficial effect of endometrial scratching, the effect of mechanical stress by intrauterine infusion on the endometrium in endometriosis patients undergoing IVF/ICSI-treatment has not been investigated yet. STUDY DESIGN, SIZE, DURATION We performed a multicentre, patient-blinded, randomised controlled trial in which women were randomly allocated to either a Gel Infusion Sonography (GIS, intervention group) or a sham procedure (control group) prior to IVF/ICSI-treatment. Since recruitment was slow and completion of the study was considered unfeasible, the study was halted after inclusion of 112 of the planned 184 women. PARTICIPANTS/MATERIALS, SETTING, METHODS We included infertile women with surgically confirmed endometriosis ASRM stage I–IV undergoing IVF/ICSI-treatment. After informed consent, women were randomised to GIS with intrauterine instillation of ExEm-gel ® or sonography with gel into the vagina (sham). This was performed in the cycle preceding the embryo transfer, on the day GnRH analogue treatment was started. The primary endpoint was live birth rate after fresh embryo transfer. Analysis was performed by both intention-to-treat and per-protocol. MAIN RESULTS AND THE ROLE OF CHANCE Between July 2014 to September 2018, we randomly allocated 112 women to GIS (n = 60) or sham procedure (n = 52). The live birth rate after fresh embryo transfer was 16/60 (26.7%) after GIS versus 8/52 (15.4%) after the sham (RR 1.73, 95% CI 0.81–3.72; P -value 0.147). Ongoing pregnancy rate was 16/60 (26.7%) after GIS versus 9/52 (17.3%) in the controls (RR 1.54, 95% CI 0.74–3.18). Miscarriage occurred in 1/60 (1.7%) after GIS versus 5/52 (9.6%) in the controls (RR 0.17, 95% CI 0.02–1.44) women. Uterine bathing resu...

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“…However, in some cases, women have experienced mild cramping pain during the investigation, and in some others, SCSH had to be terminated because of the severity of the pain . The pain during SCSH could be caused by the dilatation of the cervix or the rapid filling of the uterine cavity with saline solution . Since the introduction of the SCSH procedure, we have noticed that postmenopausal women more often feel pain during this procedure than premenopausal women do.…”

Section: Introductionmentioning

confidence: 99%

“…2,5 The pain during SCSH could be caused by the dilatation of the cervix or the rapid filling of the uterine cavity with saline solution. 9 Since the introduction of the SCSH procedure, we have noticed that postmenopausal women more often feel pain during this procedure than premenopausal women do. Therefore, the purpose of this study was to compare pain experience during and after SCSH between premenopausal and postmenopausal women.…”

Section: Introductionmentioning

confidence: 99%