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

Ovarian Cyst Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746278
• Other study ID #: SPH-CL-080512
• Status: Completed
• Phase: Phase 4
• First received: August 29, 2008
• Last updated: February 25, 2010
• Start date: September 2008
• Est. completion date: February 2010

Study information

• Verified date: May 2008
• Source: Shandong Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: February 2010
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cyst
• Ovarian Cysts

Intervention

Procedure:
• Laparoscopic ovarian cystectomy using bipolar
Laparoscopic ovarian cystectomy using bipolar
• Laparoscopic ovarian cystectomy using ultrasonic scalpel
Laparoscopic ovarian cystectomy using ultrasonic scalpel
• Laparoscopic ovarian cystectomy using suture
Laparoscopic ovarian cystectomy using suture

Locations

Country	Name	City	State
China	Shandong Provincial Hospital	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Shandong Provincial Hospital	Shandong University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum FSH and inhibin-B and Anti-Mullerian hormone(AMH) assays		12 months	Yes
Secondary	Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity		12 months	Yes