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

Primary Purpose

Ovarian Cysts

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ovarian cystectomy
Ovarian cystectomy
Ovarian cystectomy
Sponsored by
Shandong Provincial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ovarian Cysts 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
  • 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

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

Laparotomic ovarian cystectomy using suture

Outcomes

Primary Outcome Measures

Serum FSH and E2 assays

Secondary Outcome Measures

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

Full Information

First Posted
July 7, 2008
Last Updated
August 15, 2008
Sponsor
Shandong Provincial Hospital
Collaborators
Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT00713778
Brief Title
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

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (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
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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
192 (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
Arm Title
3
Arm Type
Active Comparator
Arm Description
Laparotomic ovarian cystectomy using suture
Intervention Type
Procedure
Intervention Name(s)
Ovarian cystectomy
Other Intervention Name(s)
laparoscopic ovarian cystectomy using bipolar
Intervention Description
Laparoscopic ovarian cystectomy using bipolar
Intervention Type
Procedure
Intervention Name(s)
Ovarian cystectomy
Other Intervention Name(s)
laparoscopic ovarian cystectomy using ultrasonic scalpel
Intervention Description
Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation
Intervention Type
Procedure
Intervention Name(s)
Ovarian cystectomy
Other Intervention Name(s)
Laparotomic ovarian cystectomy using suture
Intervention Description
Laparotomic ovarian cystectomy using suture
Primary Outcome Measure Information:
Title
Serum FSH and E2 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
changzhong li, M.D.
Organizational Affiliation
Shandong Provincial Hospital
Official's Role
Study Director
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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The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst

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