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

Phase 3

Completed

• Conditions: Benign Uterine Disease
• Interventions: Procedure: LH alone; Procedure: LH with opportunistic salpingectomy

• Registration Number: NCT01893086
• Lead Sponsor: CHA University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-02
• Study First Submitted QC: 2013-07-05
• Study First Posted: 2013-07-08
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LH alone	LH alone	LH, laparoscopic hysterectomy
LH with opportunistic salpingectomy	LH with opportunistic salpingectomy	LH, laparoscopic hysterectomy

Primary Outcome Measures

Name	Time	Method
Change in ovarian reserve	3 months after surgery	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.

Trial Locations

Locations (3)

Keimyung University School of Medicine; 🇰🇷 Daegu, Korea, Republic of

CHA Gangnam Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of