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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01893086
Recruitment Status : Completed
First Posted : July 8, 2013
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Taejong Song, CHA University

Tracking Information
First Submitted Date  ICMJE July 2, 2013
First Posted Date  ICMJE July 8, 2013
Last Update Posted Date January 28, 2016
Study Start Date  ICMJE June 2013
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 5, 2013)
Ovarian reserve [ Time Frame: 3 months after surgery ]
Ovarian reserve was determined by anti-Müllerian hormone (AMH)
Change History Complete list of historical versions of study NCT01893086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy
Official Title  ICMJE Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy: a Multi-center, Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Benign Uterine Disease
Intervention  ICMJE
  • Procedure: LH alone
    LH, laparoscopic hysterectomy
  • Procedure: LH with opportunistic salpingectomy
    LH, laparoscopic hysterectomy
Study Arms  ICMJE
  • Active Comparator: LH alone
    LH, laparoscopic hysterectomy
    Intervention: Procedure: LH alone
  • Experimental: LH with opportunistic salpingectomy
    LH, laparoscopic hysterectomy
    Intervention: Procedure: LH with opportunistic salpingectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 10, 2015)
68
Original Estimated Enrollment  ICMJE
 (submitted: July 5, 2013)
80
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 19 Years to 52 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01893086
Other Study ID Numbers  ICMJE KNC13-029
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Taejong Song, CHA University
Study Sponsor  ICMJE CHA University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Taejong Song, MD PhD Kangbuk Samsung Hospital, Seoul, Republic of Korea
PRS Account CHA University
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP