Ovarian Reserve Following Bilateral Salpingectomy Versus Tubal Ligation During Cesarean Section

Not Applicable

• Conditions: Ovarian Reserve
• Interventions: Procedure: Tubal ligation; Procedure: Bilateral salpingectomy

• Registration Number: NCT02377128
• Lead Sponsor: Wolfson Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-15
• Study Start: 2015-03
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-28
• Last Update Posted: 2016-04-29
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 45

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undergoing elective cesrean section at the investigators' institution, requesting sterilization, willing to have blood withdrawn for AMH levels prior to surgery, willing to participate in 8 weeks post-operation follow up with blood withdrawn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• Non-elective cesarean section, non willing to have blood withdrawn or participate in follow up, prior salpingectomy, prior premature ovarian failure/egg donation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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tubal ligation	Tubal ligation	Cesarean section with tubal ligation
Bilateral salpingectomy	Bilateral salpingectomy	Cesarean section with bilateral salpingectomy

Primary Outcome Measures

Name	Time	Method
Change from baseline in Anti Mullerian hormone (AMH) levels ng/mL at 8 weeks	Baseline and 8 weeks following surgery	AMH levels