A Random Clinical Trial (RCT) of the Impact of Electrocoagulation on Ovarian Reserve

February 25, 2010 updated by: Shandong Provincial Hospital

A Random Clinical Trial of the Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst

Laparoscopic ovarian cystectomy is widely used for the removal of benign ovarian cysts but damage to ovarian reserve caused by electrocoagulation has recently been questioned.

The purpose of this study is to investigate the impact of bipolar and ultrasonic scalpel electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Laparoscopic ovarian cystectomy is currently considered the treatment of choice in women with benign ovarian cyst and has gained increasing acceptance among gynecological surgeons(1). However, the safety of this technique in terms of ovarian damage to the operated gonad caused by electrocoagulation has recently been questioned. Many evidences support that the removal of ovarian cysts is associated with an injury to ovarian reserve. On the contrary, some retrospective studies did not show adverse outcomes compared with the control group (tubal infertility) . There is a lack of good clinical and scientific evidence such as randomized controlled study to report definitively the impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250021
        • Shandong Provincial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • age 18-40 years
  • ultrasound diagnosis as unilateral ovarian cyst and the average size between 5cm and 10cm
  • no clinical and sonographic suspicion of ovarian cancer
  • regular menstrual cycles defined as cycle length between 25 and 35 days in the 6 months before surgery
  • sonographic normal contralateral ovary
  • agreement to be enrolled in the study.

Exclusion Criteria:

  • prior ovarian surgery or known endocrine disease
  • surgical necessity to perform adnexectomy
  • intraoperative diagnosis of an abnormal contralateral ovary
  • post operative pathologic diagnosis was not benign ovarian cyst
  • oral contraceptive use before surgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Laparoscopic ovarian cystectomy using bipolar
Procedure: Laparoscopic ovarian cystectomy using bipolar
Laparoscopic ovarian cystectomy using bipolar
Experimental: 2
Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation
Procedure: Laparoscopic ovarian cystectomy using ultrasonic scalpel
Laparoscopic ovarian cystectomy using ultrasonic scalpel
Active Comparator: 3
Laparoscopic ovarian cystectomy using suture
Procedure: Laparoscopic ovarian cystectomy using suture
Laparoscopic ovarian cystectomy using suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum FSH and inhibin-B and Anti-Mullerian hormone(AMH) assays
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Provincial Hospital

Collaborators

Shandong University

Investigators

  • Study Chair: Chang-Zhong Li,, M.D.Ph.D., Shandong Provincial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

August 29, 2008

First Submitted That Met QC Criteria

August 29, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Estimate)

February 26, 2010

Last Update Submitted That Met QC Criteria

February 25, 2010

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPH-CL-080512

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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