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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Shandong Provincial Hospital

Current Primary Outcome: Serum FSH and inhibin-B and Anti-Mullerian hormone(AMH) assays [ Time Frame: 12 months ]

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: Shandong Provincial Hospital

Dates:
Date Received: August 29, 2008
Date Started: September 2008
Date Completion:
Last Updated: February 25, 2010
Last Verified: May 2008