Salpingectomy Versus Aspiration of Hydrosalpingeal Fluid Prior to IVF-ET
NCT ID: NCT02008240
Last Updated: 2015-02-18
Study Results
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Basic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2011-08-31
2014-05-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Needle aspiration of hydrosalpinx
Aspiration of hydrosalpingeal fluid under ultrasound guidance
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.
salpingectomy
Surgical removal of hydrosalpinx
Salpingectomy
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 .
Interventions
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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.
Salpingectomy
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 18 - 37 years
* Period of infertility \> 1 year
* Body mass index between 19-29
* Normal basal luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin concentrations.
* Normal recent semen analysis (according to World Health Organization criteria).
Exclusion Criteria
* Endometriosis.
* Male factor of infertility requiring ICSI, Previous IVF cycles.
* History of recurrent miscarriage.
* Endocrinologic disorders.
* Presence of systemic disease contraindicating pregnancy.
18 Years
37 Years
FEMALE
No
Sponsors
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Aljazeera Hospital
OTHER
Responsible Party
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Prof .Usama M.Fouda
M.D , PhD
Principal Investigators
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Usama M. Fouda, M.D, PhD
Role: STUDY_CHAIR
Assistant professor of Obstetrics and Gynecology , Faculty of medicine ,Cairo university , and scientific director of assisted conception unit, Aljazeera (Al Gazeera) hospital.
Ahmed M. Sayed, M.D, PhD
Role: STUDY_DIRECTOR
Assistant professor of Obstetrics and Gynecology , Faculty of medicine ,Cairo university, and clinical director of assisted conception unit, Aljazeera (Al Gazeera) hospital
Locations
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Aljazeera (Al Gazeera) hospital
Giza, Giza Governorate, Egypt
Countries
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References
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Fouda UM, Sayed AM. Effect of ultrasound-guided aspiration of hydrosalpingeal fluid during oocyte retrieval on the outcomes of in vitro fertilisation-embryo transfer: a randomised controlled trial (NCT01040351). Gynecol Endocrinol. 2011 Aug;27(8):562-7. doi: 10.3109/09513590.2010.507290. Epub 2010 Jul 30.
Strandell A, Lindhard A, Waldenstrom U, Thorburn J, Janson PO, Hamberger L. Hydrosalpinx and IVF outcome: a prospective, randomized multicentre trial in Scandinavia on salpingectomy prior to IVF. Hum Reprod. 1999 Nov;14(11):2762-9. doi: 10.1093/humrep/14.11.2762.
Fouda UM, Sayed AM, Abdelmoty HI, Elsetohy KA. Ultrasound guided aspiration of hydrosalpinx fluid versus salpingectomy in the management of patients with ultrasound visible hydrosalpinx undergoing IVF-ET: a randomized controlled trial. BMC Womens Health. 2015;15:21. doi: 10.1186/s12905-015-0177-2. Epub 2015 Feb 27.
Other Identifiers
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Hydrosalpinx2
Identifier Type: -
Identifier Source: org_study_id
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