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

Benign Uterine Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01893086
• Other study ID #: KNC13-029
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2013
• Last updated: January 26, 2016
• Start date: June 2013
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: CHA University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review BoardKorea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 52 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Uterine Disease
• Uterine Diseases

Intervention

Procedure:
• LH alone
LH, laparoscopic hysterectomy
• LH with opportunistic salpingectomy
LH, laparoscopic hysterectomy

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University School of Medicine	Daegu
Korea, Republic of	CHA Gangnam Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
CHA University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No