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

NCT01893086 | Completed Phase 3

• 1 other identifier: KNC13-029
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 3

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.

Conditions

Benign Uterine Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

LH alone

ACTIVE COMPARATOR

LH, laparoscopic hysterectomy

Procedure: LH alone

LH with opportunistic salpingectomy

EXPERIMENTAL

LH, laparoscopic hysterectomy

Procedure: LH with opportunistic salpingectomy

Interventions

LH alone PROCEDURE

LH, laparoscopic hysterectomy

LH alone

LH with opportunistic salpingectomy PROCEDURE

LH, laparoscopic hysterectomy

LH with opportunistic salpingectomy

Eligibility Criteria

• Age: 19 Years - 52 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHA University: lead

Study Sites (3)

Keimyung University School of Medicine

Daegu, 700-712, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

Location

CHA Gangnam Medical Center

Seoul, 135-081, South Korea

Location

Study Officials

• Taejong Song, MD PhD

  Kangbuk Samsung Hospital, Seoul, Republic of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 8, 2013
• Study Start: June 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

KR (3)