Comparing the Impact of 2 Different Techniques in Management of Hydrosalpinx on Pregnancy Rates Following ICSI

Study Overview
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Brief Summary
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Assessment and comparing pregnancy outcomes in hydrosalpinx patients treated by hysteroscopic tubal occlusion and laparoscopic salpingectomy before ICSI.

Detailed Description
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Hydrosalpinx has a detrimental effect on the rates of implantation, pregnancy and early pregnancy loss following IVF. A meta-analysis demonstrated that the implantation rate and clinical pregnancy rate decreased by 50% in patients with hydrosalpinx. The negative consequences could be due to embryotoxic properties, a decrease in endometrial receptivity, and hydrosalpinx fluid mechanically flushing the embryo from the uterus. Although laparoscopic salpingectomy and laparoscopic proximal ligation increase ongoing pregnancy rates in women with hydrosalpinges, those interventions are invasive and carry anaesthetic and surgical risks, especially in the presence of extensive adhesions, often seen in women with hydrosalpinges. In view of the possible adverse effects of laparoscopic surgery, an alternative less-invasive treatment for hydrosalpinges prior to IVF would be useful. The effectiveness of hysteroscopic tubal occlusion when compared with salpingectomy has not been established. Randomized clinical trials comparing both procedures prior to IVF are lacking. The present study was designed to compare hysteroscopic tubal occlusion and laparoscopic salpingectomy in the treatment of hydrosalpinges prior to IVF. This study hypothesized that in women scheduled for IVF/ICSI hysteroscopic proximal occlusion of hydrosalpinges would be non-inferior to laparoscopic salpingectomy in terms of ongoing pregnancy rates following IVF/ICSI.

Official Title
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A Clinical Trial Comparing Laparoscopic Salpingectomy Versus Hysteroscopic Proximal Tubal Occlusion on Pregnancy Rates Following ICSI (Intra-Cytoplasmic Sperm Injection) in Infertile Cases of Hydrosalpinx.

Conditions
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Hydrosalpinx

Intervention / Treatment
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* Procedure: Laparoscopic salpingectomy
* Procedure: Hystroscopic proximal tubal occlusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary or secondary infertility cases unilateral or bilateral hydrosalpinx proved by HSG (hystersalpingogram) or by TVUS(transvaginal ultrasound) . Exclusion Criteria: Uterine factor of infertility male factor of infertility preexisting ovarian pathology Presence of septic focus medical or surgical conditions that contraindicated pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>39 patients with hydrosalpinx will have laparoscopic salpingectomy | Procedure: Laparoscopic salpingectomy<br>* 39 patients with hydrosalpinx will have laparoscopic salpingectomy<br>|
| Active Comparator: Group B<br>39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion | Procedure: Hystroscopic proximal tubal occlusion<br>* 39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate following ICSI | Defined as positive qualitative bhcg(beta human chorionic gonadotropin) | 14 days after Embryo transfer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy following ICSI | Defined as positive fetal heart rate on ultrasound at 8weeks gestation | 8 weeks after Embryo transfer |