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

NCT ID: NCT00713778

Last Updated: 2008-08-18

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

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-11-30

Study Completion Date

2008-05-31

Brief Summary

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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

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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

Conditions

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Ovarian Cysts

Keywords

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Ovarian Cysts Electrocoagulation Ovarian Function Tests Laparoscopy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Laparoscopic ovarian cystectomy using bipolar

Group Type EXPERIMENTAL

Ovarian cystectomy

Intervention Type PROCEDURE

Laparoscopic ovarian cystectomy using bipolar

2

Laparoscopic ovarian cystectomy using ultrasonic scalpel

Group Type EXPERIMENTAL

Ovarian cystectomy

Intervention Type PROCEDURE

Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation

3

Laparotomic ovarian cystectomy using suture

Group Type ACTIVE_COMPARATOR

Ovarian cystectomy

Intervention Type PROCEDURE

Laparotomic ovarian cystectomy using suture

Interventions

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Ovarian cystectomy

Laparoscopic ovarian cystectomy using bipolar

Intervention Type PROCEDURE

Ovarian cystectomy

Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation

Intervention Type PROCEDURE

Ovarian cystectomy

Laparotomic ovarian cystectomy using suture

Intervention Type PROCEDURE

Other Intervention Names

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laparoscopic ovarian cystectomy using bipolar laparoscopic ovarian cystectomy using ultrasonic scalpel Laparotomic ovarian cystectomy using suture

Eligibility Criteria

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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
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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changzhong li, M.D.

Role: STUDY_DIRECTOR

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-030408

Identifier Type: -

Identifier Source: org_study_id