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

Phase 4

Completed

• Conditions: Ovarian Cyst
• Interventions: Procedure: Laparoscopic ovarian cystectomy using suture; Procedure: Laparoscopic ovarian cystectomy using bipolar; Procedure: Laparoscopic ovarian cystectomy using ultrasonic scalpel

• Registration Number: NCT00746278
• Lead Sponsor: Shandong Provincial Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2008-05
• Study First Submitted: 2008-08-29
• Study First Submitted QC: 2008-08-29
• Study Start: 2008-09
• Study First Posted: 2008-09-03
• Primary Completion: 2009-09
• Study Completion: 2010-02
• Last Update Submitted: 2010-02-25
• Last Update Posted: 2010-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Laparoscopic ovarian cystectomy using suture	Laparoscopic ovarian cystectomy using suture
1	Laparoscopic ovarian cystectomy using bipolar	Laparoscopic ovarian cystectomy using bipolar
2	Laparoscopic ovarian cystectomy using ultrasonic scalpel	Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation

Primary Outcome Measures

Name	Time	Method
Serum FSH and inhibin-B and Anti-Mullerian hormone(AMH) assays	12 months

Secondary Outcome Measures

Name	Time	Method
Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity	12 months

Trial Locations

Locations (1)

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China