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NCT Number: NCT00746278

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic ovarian cystectomy using bipolar

Procedure

Laparoscopic ovarian cystectomy using bipolar

Laparoscopic ovarian cystectomy using ultrasonic scalpel

Procedure

Laparoscopic ovarian cystectomy using ultrasonic scalpel

Laparoscopic ovarian cystectomy using suture

Procedure

Laparoscopic ovarian cystectomy using suture

Primary outcomes

  1. Serum FSH and inhibin-B and Anti-Mullerian hormone(AMH) assays

    Time frame: 12 months

Secondary outcomes

  1. Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Shandong Provincial Hospital

Other Gov

Collaborators

  • Shandong University

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Sep 3, 2008
Registry last updated
Feb 26, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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