A Random Clinical Trial (RCT) of the Impact of Electrocoagulation on Ovarian Reserve - Full Text View

Sponsors and Collaborators:	Shandong Provincial Hospital Shandong University
Information provided by:	Shandong Provincial Hospital
ClinicalTrials.gov Identifier:	NCT00746278

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 IV

MedlinePlus related topics: Ovarian Cysts

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Random Clinical Trial of the Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst

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 ]

Estimated Enrollment:	180
Study Start Date:	September 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Laparoscopic ovarian cystectomy using bipolar	Procedure: Laparoscopic ovarian cystectomy using bipolar Laparoscopic ovarian cystectomy using bipolar
2: Experimental Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation	Procedure: Laparoscopic ovarian cystectomy using ultrasonic scalpel Laparoscopic ovarian cystectomy using ultrasonic scalpel
3: Active Comparator Laparoscopic ovarian cystectomy using suture	Procedure: Laparoscopic ovarian cystectomy using suture 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	Recruiting
Jinan, Shandong, China, 250021
Contact: xiaoyong wang, Ph.D 86-531-85186215 sphec@163.com
Principal Investigator: chang-zhong Li, M.D.;Ph.D
Sub-Investigator: BO LIU, M.D.
Sub-Investigator: ZEQING WEN, M.D.

Sponsors and Collaborators

Shandong Provincial Hospital

Shandong University

Investigators

Study Chair:

Chang-Zhong Li,, M.D.Ph.D.

Shandong Provincial Hospital

More Information

Publications:

Candiani M, Barbieri M, Bottani B, Bertulessi C, Vignali M, Agnoli B, Somigliana E, Busacca M. Ovarian recovery after laparoscopic enucleation of ovarian cysts: insights from echographic short-term postsurgical follow-up. J Minim Invasive Gynecol. 2005 Sep-Oct;12(5):409-14.

Ho HY, Lee RK, Hwu YM, Lin MH, Su JT, Tsai YC. Poor response of ovaries with endometrioma previously treated with cystectomy to controlled ovarian hyperstimulation. J Assist Reprod Genet. 2002 Nov;19(11):507-11.

Loh FH, Tan AT, Kumar J, Ng SC. Ovarian response after laparoscopic ovarian cystectomy for endometriotic cysts in 132 monitored cycles. Fertil Steril. 1999 Aug;72(2):316-21.

Nargund G, Cheng WC, Parsons J. The impact of ovarian cystectomy on ovarian response to stimulation during in-vitro fertilization cycles. Hum Reprod. 1996 Jan;11(1):81-3.

Somigliana E, Ragni G, Benedetti F, Borroni R, Vegetti W, Crosignani PG. Does laparoscopic excision of endometriotic ovarian cysts significantly affect ovarian reserve? Insights from IVF cycles. Hum Reprod. 2003 Nov;18(11):2450-3.

Responsible Party:	Shandong Provincial Hospital ( Xiayong Wang Ph.D )
Study ID Numbers:	SPH-CL-080512
Study First Received:	August 29, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00746278
Health Authority:	China: Ministry of Health

Keywords provided by Shandong Provincial Hospital:

Ovarian Cysts
Electrocoagulation
Ovarian Function Tests
Laparoscopy

Study placed in the following topic categories:

Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Endocrinopathy

Ovarian Diseases
Cysts
Ovarian Cysts

Additional relevant MeSH terms:

Neoplasms
Adnexal Diseases

ClinicalTrials.gov processed this record on January 14, 2009