CompletedNCT01893086Updated Jan 28, 2016

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

A Phase 3 interventional study of LH alone and LH with opportunistic salpingectomy in Benign Uterine Disease, sponsored by CHA University. Completed at 3 sites in Korea, Republic of. Open to female participants aged 19 Years to 52 Years. Per ClinicalTrials.gov, last updated 2016-01-28.

Sponsored by CHA University · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 68
Allocation: Randomized
Ages: 19 Years to 52 Years
Sex: Female

Study 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 studied

Benign Uterine Disease

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Uterine Diseases 66

In context

Uterine Diseases

66 studies on the registry are indexed under Uterine Diseases; 8 are open to participants now.

This study's enrollment of 68 is below the median of 98 across 52 interventional studies indexed under Uterine Diseases.

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Lead sponsor

CHA University is the lead sponsor of 54 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years to 52 Years
Sexes eligible: Female
Accepts healthy volunteers: No

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

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

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 68 participants (actual)

Study arms

Active comparator
LH alone
LH, laparoscopic hysterectomy
Procedure: LH alone
Experimental
LH with opportunistic salpingectomy
LH, laparoscopic hysterectomy
Procedure: LH with opportunistic salpingectomy

Interventions

ProcedureLH alone
LH, laparoscopic hysterectomy
ProcedureLH with opportunistic salpingectomy
LH, laparoscopic hysterectomy

What researchers measure

Primary outcomes

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.
Time frame: 3 months after surgery

Study locations

3 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01893086
Lead sponsor: CHA University
Responsible party: Taejong Song (Professor, CHA University) — Principal investigator
First posted: Jul 8, 2013
Start date: Jun 2013
Primary completion: Jul 2015
Completion: Jul 2015
Last update: Jan 28, 2016

Study contacts

Taejong Song, MD PhD

principal investigator · Kangbuk Samsung Hospital, Seoul, Republic of Korea

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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