The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst

Ovarian Cysts Clinical Trial

Official title:

The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Exc

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713778
• Other study ID #: SPH-CL-030408
• Status: Completed
• Phase: Phase 4
• First received: July 7, 2008
• Last updated: August 15, 2008
• Start date: November 2003
• Est. completion date: May 2008

Study information

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

Clinical Trial Summary

The purpose of this study is to investigate the impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cyst and the possible mechanisms.

Description:

Laparoscopic cystectomy is currently considered the treatment of choice in women with benign ovarian cysts and has gained increasing acceptance among gynecological surgeons(1). However, the safety of this technique in terms of ovarian damage to the operated gonad has recently been questioned. In the present study, with the combined use of serum hormonal evaluation and ultrasound examination, we planned to prospectively investigate the ovarian reserve after the excision of benign ovarian cysts. The damage to ovarian reserve will be evaluated through a 12-months follow-up after the application of bipolar, ultrasonic scalpel electrocoagulation or suture during ovarian cystectomy

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion criteria:

• Age 18-40 years

• Uni/bilateral ovarian cyst(s) without 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

• Agreement to be enrolled in the study

Exclusion criteria:

• Prior ovarian surgery

• Surgical necessity to perform adnexectomy

• Known endocrine disease

• Post operative pathologic diagnosis was not benign ovarian cyst

• Oral contraceptive use before surgery

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Ovarian Cysts

Intervention

Procedure:
• Ovarian cystectomy
Laparoscopic ovarian cystectomy using bipolar
• Ovarian cystectomy
Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation
• Ovarian cystectomy
Laparotomic 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 E2 assays		12 months	Yes
Secondary	Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity		12 months	Yes