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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Taejong Song, CHA University
ClinicalTrials.gov Identifier:
NCT01893086
First received: July 2, 2013
Last updated: January 26, 2016
Last verified: January 2016
  Purpose
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 CHA University:

Primary Outcome Measures:
  • Change in ovarian reserve [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   19 Years to 52 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01893086

Locations
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
Investigators
Principal Investigator: Taejong Song, MD PhD Kangbuk Samsung Hospital, Seoul, Republic of Korea
  More Information

Responsible Party: Taejong Song, Professor, CHA University
ClinicalTrials.gov Identifier: NCT01893086     History of Changes
Other Study ID Numbers: KNC13-029 
Study First Received: July 2, 2013
Last Updated: January 26, 2016
Health Authority: Korea: Institutional Review Board
Korea: Food and Drug Administration

Additional relevant MeSH terms:
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on December 02, 2016