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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ovarian Cyst

Intervention / Treatment
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* Procedure: Laparoscopic ovarian cystectomy using bipolar
* Procedure: Laparoscopic ovarian cystectomy using ultrasonic scalpel
* Procedure: Laparoscopic ovarian cystectomy using suture


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Laparoscopic ovarian cystectomy using bipolar | Procedure: Laparoscopic ovarian cystectomy using bipolar<br>* Laparoscopic ovarian cystectomy using bipolar<br>|
| Experimental: 2<br>Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation | Procedure: Laparoscopic ovarian cystectomy using ultrasonic scalpel<br>* Laparoscopic ovarian cystectomy using ultrasonic scalpel<br>|
| Active Comparator: 3<br>Laparoscopic ovarian cystectomy using suture | Procedure: Laparoscopic ovarian cystectomy using suture<br>* Laparoscopic ovarian cystectomy using suture<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Cysts, Electrocoagulation, Ovarian Function Tests, Laparoscopy