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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00746278

Enrollment

180

Registered

2008-09-03

Start date

2008-09-30

Completion date

2010-02-28

Last updated

2010-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cyst

Keywords

Ovarian Cysts, Electrocoagulation, Ovarian Function Tests, Laparoscopy

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.

Interventions

PROCEDURELaparoscopic ovarian cystectomy using bipolar

Laparoscopic ovarian cystectomy using bipolar

PROCEDURELaparoscopic ovarian cystectomy using ultrasonic scalpel

Laparoscopic ovarian cystectomy using ultrasonic scalpel

PROCEDURELaparoscopic ovarian cystectomy using suture

Laparoscopic ovarian cystectomy using suture

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026