Clinical trial NCT00713778: The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst
Official title: The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Exc
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ovarian Cysts
Keywords: Ovarian Cysts
Electrocoagulation
Ovarian Function Tests
Laparoscopy
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Shandong University
First posted: 2008-07-11
Enrollment: 192
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Serum FSH and E2 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: changzhong li, M.D.
role: STUDY_DIRECTOR
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.