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

Primary Purpose

Ovarian Cyst

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Laparoscopic ovarian cystectomy using bipolar
Laparoscopic ovarian cystectomy using ultrasonic scalpel
Laparoscopic ovarian cystectomy using suture
Sponsored by
Shandong Provincial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cyst focused on measuring Ovarian Cysts, Electrocoagulation, Ovarian Function Tests, Laparoscopy

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Shandong Provincial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Laparoscopic ovarian cystectomy using bipolar

Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation

Laparoscopic ovarian cystectomy using suture

Outcomes

Primary Outcome Measures

Serum FSH and inhibin-B and Anti-Mullerian hormone(AMH) assays

Secondary Outcome Measures

Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity

Full Information

First Posted
August 29, 2008
Last Updated
February 25, 2010
Sponsor
Shandong Provincial Hospital
Collaborators
Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT00746278
Brief Title
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

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shandong Provincial Hospital
Collaborators
Shandong University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cyst
Keywords
Ovarian Cysts, Electrocoagulation, Ovarian Function Tests, Laparoscopy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Laparoscopic ovarian cystectomy using bipolar
Arm Title
2
Arm Type
Experimental
Arm Description
Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation
Arm Title
3
Arm Type
Active Comparator
Arm Description
Laparoscopic ovarian cystectomy using suture
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic ovarian cystectomy using bipolar
Intervention Description
Laparoscopic ovarian cystectomy using bipolar
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic ovarian cystectomy using ultrasonic scalpel
Intervention Description
Laparoscopic ovarian cystectomy using ultrasonic scalpel
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic ovarian cystectomy using suture
Intervention Description
Laparoscopic ovarian cystectomy using suture
Primary Outcome Measure Information:
Title
Serum FSH and inhibin-B and Anti-Mullerian hormone(AMH) assays
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang-Zhong Li,, M.D.Ph.D.
Organizational Affiliation
Shandong Provincial Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250021
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
16213426
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.
Results Reference
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PubMed Identifier
12484492
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.
Results Reference
background
PubMed Identifier
10439003
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.
Results Reference
background
PubMed Identifier
8671163
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.
Results Reference
background
PubMed Identifier
14585900
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.
Results Reference
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A Random Clinical Trial (RCT) of the Impact of Electrocoagulation on Ovarian Reserve

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