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

This study has been completed.
Information provided by (Responsible Party):
Taejong Song, CHA University Identifier:
First received: July 2, 2013
Last updated: January 26, 2016
Last verified: January 2016
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.

Condition Intervention Phase
Benign Uterine Disease Procedure: LH alone Procedure: LH with opportunistic salpingectomy Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy: a Multi-center, Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Taejong Song, CHA University:

Primary Outcome Measures:
  • Change in ovarian reserve [ Time Frame: 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.

Enrollment: 68
Study Start Date: June 2013
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LH alone
LH, laparoscopic hysterectomy
Procedure: LH alone
LH, laparoscopic hysterectomy
Experimental: LH with opportunistic salpingectomy
LH, laparoscopic hysterectomy
Procedure: LH with opportunistic salpingectomy
LH, laparoscopic hysterectomy


Ages Eligible for Study:   19 Years to 52 Years   (Adult)
Sexes Eligible for Study:   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:

  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01893086

Korea, Republic of
Keimyung University School of Medicine
Daegu, Korea, Republic of, 700-712
Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 110-746
CHA Gangnam Medical Center
Seoul, Korea, Republic of, 135-081
Sponsors and Collaborators
CHA University
Principal Investigator: Taejong Song, MD PhD Kangbuk Samsung Hospital, Seoul, Republic of Korea
  More Information

Responsible Party: Taejong Song, Professor, CHA University Identifier: NCT01893086     History of Changes
Other Study ID Numbers: KNC13-029
Study First Received: July 2, 2013
Last Updated: January 26, 2016

Additional relevant MeSH terms:
Uterine Diseases
Genital Diseases, Female processed this record on September 21, 2017