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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01893086
Enrollment
68
Registered
2013-07-08
Start date
2013-06-30
Completion date
2015-07-31
Last updated
2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Uterine Disease

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.

Interventions

PROCEDURELH alone

LH, laparoscopic hysterectomy

PROCEDURELH with opportunistic salpingectomy

LH, laparoscopic hysterectomy

Sponsors

CHA University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
19 Years to 52 Years
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Change in ovarian reserve3 months after surgeryThe 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026