Back to resultsImpact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy
Primary Purpose
Benign Uterine Disease
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LH alone
LH with opportunistic salpingectomy
Sponsored by
About this trial
This is an interventional treatment trial for Benign Uterine Disease
Eligibility 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.
Sites / Locations
- Keimyung University School of Medicine
- Kangbuk Samsung Hospital
- CHA Gangnam Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
LH alone
LH with opportunistic salpingectomy
Arm Description
LH, laparoscopic hysterectomy
LH, laparoscopic hysterectomy
Outcomes
Primary Outcome Measures
Change in ovarian reserve
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01893086
Brief Title
Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy
Official Title
Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy: a Multi-center, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHA University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Uterine Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LH alone
Arm Type
Active Comparator
Arm Description
LH, laparoscopic hysterectomy
Arm Title
LH with opportunistic salpingectomy
Arm Type
Experimental
Arm Description
LH, laparoscopic hysterectomy
Intervention Type
Procedure
Intervention Name(s)
LH alone
Intervention Description
LH, laparoscopic hysterectomy
Intervention Type
Procedure
Intervention Name(s)
LH with opportunistic salpingectomy
Intervention Description
LH, laparoscopic hysterectomy
Primary Outcome Measure Information:
Title
Change in ovarian reserve
Description
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.
Time Frame
3 months after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
52 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taejong Song, MD PhD
Organizational Affiliation
Kangbuk Samsung Hospital, Seoul, Republic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keimyung University School of Medicine
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
110-746
Country
Korea, Republic of
Facility Name
CHA Gangnam Medical Center
City
Seoul
ZIP/Postal Code
135-081
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Impact of Opportunistic Salpingectomy on Ovarian Reserve in Patients Undergoing Laparoscopic Hysterectomy
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