Trial record 5 of 17 for:    salpingectomy

Salpingectomy Versus Aspiration of Hydrosalpingeal Fluid Prior to IVF-ET

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof .Usama M.Fouda, Aljazeera Hospital
ClinicalTrials.gov Identifier:
NCT02008240
First received: December 8, 2013
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Infertility
Procedure: Needle aspiration of hydrosalpinx
Procedure: Salpingectomy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Salpingectomy Versus Aspiration of Hydrosalpingeal Fluid Prior to IVF-ET.A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Aljazeera Hospital:

Primary Outcome Measures:
  • The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle [ Time Frame: 5 weeks after embryo transfer ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle . [ Time Frame: 18 weeks after embryo transfer ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: August 2011
Study Completion Date: May 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 37 Years
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02008240

Locations
Egypt
Aljazeera hospital
Giza, Egypt
Sponsors and Collaborators
Aljazeera Hospital
Investigators
Study Chair: Usama M. Fouda, M.D , PhD Assistant professor of Obstetrics and Gynecology , Faculty of medicine ,Cairo university
Study Director: Ahmed M. Sayed, M.D , PhD Assistant professor of Obstetrics and Gynecology , Faculty of medicine ,Cairo university
  More Information

Publications:
Responsible Party: Prof .Usama M.Fouda, M.D , PhD, Aljazeera Hospital
ClinicalTrials.gov Identifier: NCT02008240     History of Changes
Other Study ID Numbers: Hydrosalpinx2
Study First Received: December 8, 2013
Last Updated: June 19, 2014
Health Authority: Egypt: Institutional Review Board

Keywords provided by Aljazeera Hospital:
Infertility
Hydrosalpinx
IVF-ET
Salpingectomy

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 01, 2014