The Effect on Risk-reducing Salpingectomy in Hysterectomy on Ovarian Reserve

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by CHA University
Sponsor:
Information provided by (Responsible Party):
Taejong Song, CHA University
ClinicalTrials.gov Identifier:
NCT01893086
First received: July 2, 2013
Last updated: December 24, 2014
Last verified: December 2014
  Purpose

Recently, many gynecologic oncologists proposed that surgeons should consider risk-reducing salpingectomy (RRS) to prevent ovarian cancer for all patients undergoing hysterectomy for benign disease. However, the safety and the consequences regarding ovarian function after RSS 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 RSS.


Condition Intervention Phase
Benign Uterine Disease
Procedure: LH
Procedure: RSS
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: The Effect on Risk-reducing Salpingectomy in Laparoscopic Hysterectomy on Ovarian Reserve: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by CHA University:

Primary Outcome Measures:
  • Ovarian reserve [ Time Frame: 3 months after surgery ] [ Designated as safety issue: No ]
    Ovarian reserve was determined by anti-Müllerian hormone (AMH)


Estimated Enrollment: 100
Study Start Date: June 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LH alone
LH, laparoscopic hysterectomy
Procedure: LH
Active Comparator: LH with RSS
LH, laparoscopic hysterectomy; RSS, risk-reducing salpingectomy
Procedure: LH Procedure: RSS

  Eligibility

Ages Eligible for Study:   18 Years to 52 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women with an age ≥18 years and less than 52 years
  • women who scheduled for laparoscopic hysterectomy with planed preservation of both ovaries for a supposed benign gynecologic condition
  • non-menopausal women
  • women who were appropriated medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)

Exclusion Criteria:

  • any ovarian mass with planed ovarian surgery; menopausal state; history of prior salpingectomy
  • pregnancy at the time of presentation; or 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

Contacts
Contact: Taejong Song, MD PhD +82-10-4035-8405 taejong.song@gmail.com

Locations
Korea, Republic of
Keimyung University School of Medicine Recruiting
Daegu, Korea, Republic of, 700-712
Contact: Sang-Hoon Kwon, MD, PhD    +82-53-250-7992    ksh1999@dsmc.or.kr   
Principal Investigator: Sang-Hoon Kwon, MD, PhD         
CHA Gangnam Medical Center Recruiting
Seoul, Korea, Republic of, 135-081
Contact: Seok Ju Seong, MD PhD    +81-2-3468-3000    sjseongcheil@naver.com   
Principal Investigator: Seok Ju Seong, MD, PhD         
Kangbuk Samsung Hospital Recruiting
Seoul, Korea, Republic of, 110-746
Contact: Taejong Song, MD PhD    +82-2-2001-2582    taejong.song@gmail.com   
Principal Investigator: Taejong Song, MD PhD         
Sponsors and Collaborators
CHA University
Investigators
Principal Investigator: Taejong Song, MD PhD Kangbuk Samsung Hospital, Seoul, Republic of Korea
  More Information

No publications provided

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: December 24, 2014
Health Authority: Korea: Institutional Review Board
Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on March 31, 2015