Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy

Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy: a Multi-center, Randomized Controlled Trial

Recently, many gynecologic oncologists proposed that surgeons should consider opportunistic salpingectomy to prevent ovarian cancer for all patients undergoing hysterectomy for benign disease. However, the safety and the consequences regarding ovarian function after salpingectomy have not yet to be established. Therefore, the aim of this randomized controlled study is compare the ovarian reserve via anti-Müllerian hormone (AMH) between laparoscopic hysterectomy (LH) alone and LH combined with salpingectomy.

Study Overview

• Status: Completed
• Conditions: Benign Uterine Disease
• Intervention / Treatment: Procedure: LH alone; Procedure: LH with opportunistic salpingectomy

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 700-712
    • Keimyung University School of Medicine
  • Seoul, Korea, Republic of, 110-746
    • Kangbuk Samsung Hospital
  • Seoul, Korea, Republic of, 135-081
    • CHA Gangnam Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 52 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• women who were planning to undergo laparoscopic hysterectomy for benign uterine diseases
• women aged between 19 and 52 years
• women with regular menstruation (defined as the duration of menstrual cycle between 21 and 45 days)
• women who were appropriated medical status for laparoscopic surgery

Exclusion Criteria:

• any ovarian cysts requiring ovarian surgery
• any suspicious findings of malignant diseases
• history of prior salpingectomy or salpingo-oophorectomy
• pregnant or menopausal status
• preoperative serum anti-Müllerian hormone (AMH) < 0.30 ng/mL
• use of hormonal treatments in the three months before surgery
• any other endocrine disease (such as uncontrolled thyroid dysfunction, hyperprolactinemia, or Cushing syndrome)
• an inability to understand and provide written informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: LH alone; LH, laparoscopic hysterectomy	Procedure: LH alone; LH, laparoscopic hysterectomy
EXPERIMENTAL: LH with opportunistic salpingectomy; LH, laparoscopic hysterectomy	Procedure: LH with opportunistic salpingectomy; LH, laparoscopic hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ovarian reserve	The primary outcome measure was the change of ovarian reserve, determined by the rate of decline in AMH level from before surgery to 3-month post-surgery with the following formula : decline rate (%) = 100 × (preoperative AMH level - postoperative AMH level) ÷ preoperative AMH level.	3 months after surgery

Collaborators and Investigators

• Sponsor: CHA University

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): July 1, 2015

Study Registration Dates

• First Submitted: July 2, 2013
• First Submitted That Met QC Criteria: July 5, 2013
• First Posted (ESTIMATE): July 8, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases
• Other Study ID Numbers: KNC13-029