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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
Sponsor:
Information provided by (Responsible Party):
Prof .Usama M.Fouda, Aljazeera Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infertility Procedure: Needle aspiration of hydrosalpinx Procedure: Salpingectomy Phase 2

Detailed Description:

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
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
Procedure: 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 Name: surgical removal of hydrosalpinx




Primary Outcome Measures :
  1. The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle [ Time Frame: 5 weeks after embryo transfer ]

Secondary Outcome Measures :
  1. The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle . [ Time Frame: 18 weeks after embryo transfer ]


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Ages Eligible for Study:   18 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with unilateral or bilateral hydrosalpinges visible by ultrasound
  • 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:

  • Uterine fibroid requiring surgical removal.
  • Endometriosis.
  • Male factor of infertility requiring ICSI, Previous IVF cycles.
  • History of recurrent miscarriage.
  • Endocrinologic disorders.
  • Presence of systemic disease contraindicating pregnancy.

Information from the National Library of Medicine

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


Locations
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Egypt
Aljazeera (Al Gazeera) hospital
Giza, Egypt
Sponsors and Collaborators
Aljazeera Hospital
Investigators
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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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof .Usama M.Fouda, M.D , PhD, Aljazeera Hospital
ClinicalTrials.gov Identifier: NCT02008240     History of Changes
Other Study ID Numbers: Hydrosalpinx2
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: February 18, 2015
Last Verified: February 2015
Keywords provided by Prof .Usama M.Fouda, Aljazeera Hospital:
Infertility
Hydrosalpinx
IVF-ET
Salpingectomy
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female