Clinical trial NCT00746278: A Random Clinical Trial (RCT) of the Impact of Electrocoagulation on Ovarian Reserve
Official title: A Random Clinical Trial of the Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ovarian Cyst
Keywords: Ovarian Cysts
Electrocoagulation
Ovarian Function Tests
Laparoscopy
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Shandong University
First posted: 2008-09-03
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Serum FSH and inhibin-B and Anti-Mullerian hormone(AMH) assays
timeFrame: 12 months
Secondary outcomes:
measure: Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity
timeFrame: 12 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Chang-Zhong Li,, M.D.Ph.D.
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1016/j.jmig.2005.06.006.
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. doi: 10.1023/a:1020970417778.
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. doi: 10.1016/s0015-0282(99)00207-1.
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. doi: 10.1093/oxfordjournals.humrep.a019043.
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. doi: 10.1093/humrep/deg432.