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

This study has been completed.
Sponsor:
Collaborator:
Shandong University
Information provided by:
Shandong Provincial Hospital
ClinicalTrials.gov Identifier:
NCT00746278
First received: August 29, 2008
Last updated: February 25, 2010
Last verified: May 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Ovarian Cyst
 Procedure: Laparoscopic ovarian cystectomy using bipolar
Procedure: Laparoscopic ovarian cystectomy using ultrasonic scalpel
Procedure: Laparoscopic ovarian cystectomy using suture
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Random Clinical Trial of the Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst

Resource links provided by NLM:

MedlinePlus related topics: Ovarian Cysts
U.S. FDA Resources

Further study details as provided by Shandong Provincial Hospital:

Primary Outcome Measures:
  • Serum FSH and inhibin-B and Anti-Mullerian hormone(AMH) assays [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 180
Study Start Date: September 2008
Study Completion Date: February 2010
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Laparoscopic ovarian cystectomy using bipolar
 Procedure: Laparoscopic ovarian cystectomy using bipolar
Laparoscopic ovarian cystectomy using bipolar
Other Name: Laparoscopic ovarian cystectomy using bipolar
Experimental: 2
Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation
 Procedure: Laparoscopic ovarian cystectomy using ultrasonic scalpel
Laparoscopic ovarian cystectomy using ultrasonic scalpel
Other Name: Laparoscopic ovarian cystectomy using ultrasonic scalpel
Active Comparator: 3
Laparoscopic ovarian cystectomy using suture
 Procedure: Laparoscopic ovarian cystectomy using suture
Laparoscopic ovarian cystectomy using suture
Other Name: Laparoscopic ovarian cystectomy using suture

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746278

Locations
China, Shandong
Shandong Provincial Hospital
Jinan, Shandong, China, 250021
Sponsors and Collaborators
Shandong Provincial Hospital
Shandong University
Investigators
Study Chair: Chang-Zhong Li,, M.D.Ph.D. Shandong Provincial Hospital
  More Information

Publications:

Responsible Party: Xiayong Wang Ph.D, Shandong Provincial Hospital
ClinicalTrials.gov Identifier: NCT00746278     History of Changes
Other Study ID Numbers: SPH-CL-080512
Study First Received: August 29, 2008
Last Updated: February 25, 2010
Health Authority: China: Ministry of Health

Keywords provided by Shandong Provincial Hospital:
Ovarian Cysts
Electrocoagulation
Ovarian Function Tests
Laparoscopy

Additional relevant MeSH terms:
Cysts
Ovarian Cysts
Neoplasms
Pathological Conditions, Anatomical
Ovarian Diseases
 Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 22, 2013