Clinical trial NCT02377128: Ovarian Reserve Following Bilateral Salpingectomy Versus Tubal Ligation During Cesarean Section
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Reserve
Keywords: Study
focus
ovarian
reserve
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-03-03
Enrollment: 45
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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undergoing elective cesrean section at the investigators' institution, requesting sterilization, willing to have blood withdrawn for AMH levels prior to surgery, willing to participate in 8 weeks post-operation follow up with blood withdrawn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* Non-elective cesarean section, non willing to have blood withdrawn or participate in follow up, prior salpingectomy, prior premature ovarian failure/egg donation

Primary outcomes:
measure: Change from baseline in Anti Mullerian hormone (AMH) levels ng/mL at 8 weeks
timeFrame: Baseline and 8 weeks following surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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