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

The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Exc

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Cysts
• Intervention / Treatment: Procedure: Ovarian cystectomy; Procedure: Ovarian cystectomy; Procedure: Ovarian cystectomy

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

• Study Type: Interventional
• Enrollment (Actual): 192
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250021
      • Shandong Provincial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Laparoscopic ovarian cystectomy using bipolar	Procedure: Ovarian cystectomy; Laparoscopic ovarian cystectomy using bipolar; Other Names: laparoscopic ovarian cystectomy using bipolar; Procedure: Ovarian cystectomy; Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation; Other Names: laparoscopic ovarian cystectomy using ultrasonic scalpel; Procedure: Ovarian cystectomy; Laparotomic ovarian cystectomy using suture; Other Names: Laparotomic ovarian cystectomy using suture
EXPERIMENTAL: 2; Laparoscopic ovarian cystectomy using ultrasonic scalpel	Procedure: Ovarian cystectomy; Laparoscopic ovarian cystectomy using bipolar; Other Names: laparoscopic ovarian cystectomy using bipolar; Procedure: Ovarian cystectomy; Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation; Other Names: laparoscopic ovarian cystectomy using ultrasonic scalpel; Procedure: Ovarian cystectomy; Laparotomic ovarian cystectomy using suture; Other Names: Laparotomic ovarian cystectomy using suture
ACTIVE_COMPARATOR: 3; Laparotomic ovarian cystectomy using suture	Procedure: Ovarian cystectomy; Laparoscopic ovarian cystectomy using bipolar; Other Names: laparoscopic ovarian cystectomy using bipolar; Procedure: Ovarian cystectomy; Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation; Other Names: laparoscopic ovarian cystectomy using ultrasonic scalpel; Procedure: Ovarian cystectomy; Laparotomic ovarian cystectomy using suture; Other Names: Laparotomic ovarian cystectomy using suture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum FSH and E2 assays	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity	12 months

Collaborators and Investigators

• Sponsor: Shandong Provincial Hospital
• Collaborators: Shandong University
• Investigators: Study Director: changzhong li, M.D., Shandong Provincial Hospital

Publications and helpful links

General 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. doi: 10.1016/j.jmig.2005.06.006.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2003
• Primary Completion (ACTUAL): May 1, 2008
• Study Completion (ACTUAL): May 1, 2008

Study Registration Dates

• First Submitted: July 7, 2008
• First Submitted That Met QC Criteria: July 7, 2008
• First Posted (ESTIMATE): July 11, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 18, 2008
• Last Update Submitted That Met QC Criteria: August 15, 2008
• Last Verified: July 1, 2008

More Information

Terms related to this study

• Keywords: Laparoscopy; Ovarian Cysts; Electrocoagulation; Ovarian Function Tests
• Additional Relevant MeSH Terms: Neoplasms; Endocrine System Diseases; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Cysts
• Other Study ID Numbers: SPH-CL-030408