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The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst
This study has been completed.
Study NCT00713778   Information provided by Shandong Provincial Hospital
First Received: July 7, 2008   Last Updated: August 15, 2008   History of Changes

July 7, 2008
August 15, 2008
November 2003
May 2008   (final data collection date for primary outcome measure)
Serum FSH and E2 assays [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
serum FSH and E2 assays [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00713778 on ClinicalTrials.gov Archive Site
Transvaginal ultrasound examinations for basal antral follicle number, mean ovarian diameter and peak systolic velocity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
 
The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Excision of Ovarian Cyst
The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Exc

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.

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

Phase IV
Interventional
Supportive Care, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Ovarian Cysts
Procedure: Ovarian cystectomy
  • Experimental: Laparoscopic ovarian cystectomy using bipolar
  • Experimental: Laparoscopic ovarian cystectomy using ultrasonic scalpel
  • Active Comparator: Laparotomic ovarian cystectomy using suture

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
192
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00713778
Xiayong Wang Ph.D, Shandong Provincial Hospital
SPH-CL-030408
Shandong Provincial Hospital
Shandong University
Study Director: changzhong li, M.D. Shandong Provincial Hospital
Shandong Provincial Hospital
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP