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

NCT ID: NCT00746278

Last Updated: 2010-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-02-28

Brief Summary

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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

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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.

Conditions

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Ovarian Cyst

Keywords

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Ovarian Cysts Electrocoagulation Ovarian Function Tests Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Laparoscopic ovarian cystectomy using bipolar

Group Type EXPERIMENTAL

Laparoscopic ovarian cystectomy using bipolar

Intervention Type PROCEDURE

Laparoscopic ovarian cystectomy using bipolar

2

Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation

Group Type EXPERIMENTAL

Laparoscopic ovarian cystectomy using ultrasonic scalpel

Intervention Type PROCEDURE

Laparoscopic ovarian cystectomy using ultrasonic scalpel

3

Laparoscopic ovarian cystectomy using suture

Group Type ACTIVE_COMPARATOR

Laparoscopic ovarian cystectomy using suture

Intervention Type PROCEDURE

Laparoscopic ovarian cystectomy using suture

Interventions

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Laparoscopic ovarian cystectomy using bipolar

Laparoscopic ovarian cystectomy using bipolar

Intervention Type PROCEDURE

Laparoscopic ovarian cystectomy using ultrasonic scalpel

Laparoscopic ovarian cystectomy using ultrasonic scalpel

Intervention Type PROCEDURE

Laparoscopic ovarian cystectomy using suture

Laparoscopic ovarian cystectomy using suture

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shandong University

OTHER

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Shandong Provincial Hospital

Principal Investigators

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Chang-Zhong Li,, M.D.Ph.D.

Role: STUDY_CHAIR

Shandong Provincial Hospital

Locations

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Shandong Provincial Hospital

Jinan, Shandong, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 16213426 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12484492 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10439003 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8671163 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14585900 (View on PubMed)

Other Identifiers

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SPH-CL-080512

Identifier Type: -

Identifier Source: org_study_id