Salpingectomy Versus Aspiration of Hydrosalpingeal Fluid Prior to IVF-ET
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|ClinicalTrials.gov Identifier: NCT02008240|
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : February 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Procedure: Needle aspiration of hydrosalpinx Procedure: Salpingectomy||Phase 2|
The adverse impact of hydrosalpinx on in vitro fertilisation embryo transfer (IVF-ET) outcomes has been confirmed by several retrospective and prospective studies .
Cochrane review of prospective randomised trials of laparoscopic salpingectomy confirmed the beneficial effect of laparoscopic salpingectomy on IVF-ET outcomes in patients with hydrosalpinges.
Surgery is not usually safe especially in patients with extensive adhesions, morbid obesity or previous multiple laparotomies. Furthermore, many infertile couples refuse to undergo bilateral salpingectomy or proximal tubal occlusion because these procedures remove any hope of spontaneous pregnancy. Other less invasive options for patients with hydrosalpinges as ultrasound-guided aspiration of hydrosalpingeal fluid, antibiotics (alone or combined with aspiration) and hysteroscopic occlusion of fallopian tube were studied in order to find an alternative to salpingectomy . Although these methods are simple and getting popular, current data are inadequate to recommend these treatment options instead of salpingectomy because most of the supporting evidences for these methods come from small retrospective studies.
A recent randomized controlled trial revealed that the aspiration of hydrosalpingeal fluid at the time of oocyte retrieval was associated with improved implantation rate and pregnancy rates.
The aim of this randomized controlled trial is to compare the efficacy of ultrasound guided aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with ultrasound visible hydrosalpinges undergoing IVF-ET
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Salpingectomy Versus Aspiration of Hydrosalpingeal Fluid Prior to IVF-ET.A Randomized Controlled Trial|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||May 2014|
Experimental: Needle aspiration of hydrosalpinx
Aspiration of hydrosalpingeal fluid under ultrasound guidance
Procedure: Needle aspiration of hydrosalpinx
Under deep sedation, the retrieval of oocytes is done and then an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely . If there are bilateral hydrosalpinges, the process is repeated on the opposite side.
Other Name: ultrasound guidance aspiration of hydrosalpingeal fluid
Active Comparator: salpingectomy
Surgical removal of hydrosalpinx
laparoscopic surgical removal of affected tube is done with bipolar electrocoagulation for hemostasis. The mesosalpinx is coagulated as close a possible to the fallopian tube to avoid any compromise in the ovarian blood supply . In cases with marked adhesion, proximal ligation and a distal fenestration is done .
Other Name: surgical removal of hydrosalpinx
- The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle [ Time Frame: 5 weeks after embryo transfer ]
- The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle . [ Time Frame: 18 weeks after embryo transfer ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008240
|Aljazeera (Al Gazeera) hospital|
|Study Chair:||Usama M. Fouda, M.D, PhD||Assistant professor of Obstetrics and Gynecology , Faculty of medicine ,Cairo university , and scientific director of assisted conception unit, Aljazeera (Al Gazeera) hospital.|
|Study Director:||Ahmed M. Sayed, M.D, PhD||Assistant professor of Obstetrics and Gynecology , Faculty of medicine ,Cairo university, and clinical director of assisted conception unit, Aljazeera (Al Gazeera) hospital|