Ovarian Reserve Following Bilateral Salpingectomy Versus Tubal Ligation During Cesarean Section

April 28, 2016 updated by: Hadas Ganer Herman, Wolfson Medical Center
The aforementioned study was designed to evaluate short term ovarian reserve as assessed by anti-Mullerian hormone(AMH) levels following bilateral salpingectomy versus tubal ligation, as part of cesarean sections performed in women requesting future sterilization. The investigators aim to recruit 3 groups of 15 women undergoing elective cesarean section at the investigators' institution, 2 of which request sterilization (allocated to tubal ligation or bilateral salpingectomy) and one undergoing solely cesarean section. The groups will have blood drawn for AMH prior to the procedure and at a post-operation visit 8 weeks following. This is preformed in light of validated data offering better sterilization and possible diminished future risk of ovarian cancer with salpingectomy. Also, is has been proved to be just as safe as tubal ligation. This will be performed as a randomized controlled trial.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women undergoing elective cesrean section at the investigators' institution, requesting sterilization, willing to have blood withdrawn for AMH levels prior to surgery, willing to participate in 8 weeks post-operation follow up with blood withdrawn

Exclusion Criteria:

  • Non-elective cesarean section, non willing to have blood withdrawn or participate in follow up, prior salpingectomy, prior premature ovarian failure/egg donation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bilateral salpingectomy
Cesarean section with bilateral salpingectomy
Surgical bilateral removal of fallopian tubes (not involving ovaries)
Active Comparator: Tubal ligation
Cesarean section with tubal ligation
Bilateral ligation of fallopian tubes (not involving ovaries)
No Intervention: No intervention
Cesarean section with no additional intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Anti Mullerian hormone (AMH) levels ng/mL at 8 weeks
Time Frame: Baseline and 8 weeks following surgery
AMH levels
Baseline and 8 weeks following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

February 15, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Estimate)

April 29, 2016

Last Update Submitted That Met QC Criteria

April 28, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 0028-15-WOMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Reserve

Clinical Trials on Bilateral salpingectomy

3
Subscribe