Comparing the Impact of 2 Different Techniques in Management of Hydrosalpinx on Pregnancy Rates Following ICSI
NCT ID: NCT04335864
Last Updated: 2021-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
78 participants
INTERVENTIONAL
2020-04-01
2020-12-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group A
39 patients with hydrosalpinx will have laparoscopic salpingectomy
Laparoscopic salpingectomy
39 patients with hydrosalpinx will have laparoscopic salpingectomy
Group B
39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion
Hystroscopic proximal tubal occlusion
39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion
Interventions
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Laparoscopic salpingectomy
39 patients with hydrosalpinx will have laparoscopic salpingectomy
Hystroscopic proximal tubal occlusion
39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion
Eligibility Criteria
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Inclusion Criteria
* unilateral or bilateral hydrosalpinx proved by HSG (hystersalpingogram) or by TVUS(transvaginal ultrasound) .
Exclusion Criteria
* male factor of infertility
* preexisting ovarian pathology
* Presence of septic focus
* medical or surgical conditions that contraindicated pregnancy
18 Years
40 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Shaimaa Mostafa Mohammed Refaay El shemy
Principal investigator, Lecturer in obstetrics and gyneocolgy department, Cairo university
Locations
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Kasr Alainy hospital-cairo University
Cairo, , Egypt
Countries
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Other Identifiers
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Hydrosalpinx and ICSI
Identifier Type: -
Identifier Source: org_study_id
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