The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst - Full Text View

Sponsor:	Shandong Provincial Hospital
Collaborator:	Shandong University
Information provided by:	Shandong Provincial Hospital
ClinicalTrials.gov Identifier:	NCT00713778

Purpose

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.

Condition	Intervention	Phase
Ovarian Cysts	Procedure: Ovarian cystectomy	Phase IV

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Exc

Resource links provided by NLM:

MedlinePlus related topics: Ovarian Cysts

U.S. FDA Resources

Further study details as provided by Shandong Provincial Hospital:

Primary Outcome Measures:

Serum FSH and E2 assays [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	192
Study Start Date:	November 2003
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Laparoscopic ovarian cystectomy using bipolar	Procedure: Ovarian cystectomy Laparoscopic ovarian cystectomy using bipolar
2: Experimental Laparoscopic ovarian cystectomy using ultrasonic scalpel	Procedure: Ovarian cystectomy Laparoscopic ovarian cystectomy using ultrasonic scalpel electrocoagulation
3: Active Comparator Laparotomic ovarian cystectomy using suture	Procedure: Ovarian cystectomy Laparotomic ovarian cystectomy using suture

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

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713778

Locations

China, Shandong
Shandong Provincial Hospital
jinan, Shandong, China, 250021

Sponsors and Collaborators

Shandong Provincial Hospital

Shandong University

Investigators

Study Director:

changzhong li, M.D.

Shandong Provincial Hospital

More Information

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.

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.

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.

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.

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.

Responsible Party:	Shandong Provincial Hospital ( Xiayong Wang Ph.D )
Study ID Numbers:	SPH-CL-030408
Study First Received:	July 7, 2008
Last Updated:	August 15, 2008
ClinicalTrials.gov Identifier:	NCT00713778 History of Changes
Health Authority:	China: Ministry of Health

Keywords provided by Shandong Provincial Hospital:

Ovarian Cysts
Electrocoagulation
Ovarian Function Tests
Laparoscopy

Additional relevant MeSH terms:

Genital Diseases, Female
Pathological Conditions, Anatomical
Neoplasms
Gonadal Disorders
Endocrine System Diseases

Ovarian Diseases
Cysts
Ovarian Cysts
Adnexal Diseases

ClinicalTrials.gov processed this record on November 05, 2009