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NCT Number: NCT00713778

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

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.

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Key information

Conditions

Ovarian Cysts Adnexal Diseases Body Temperature Changes Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Heat Stress Disorders Hyperthermia Neoplasms Ovarian Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases Wounds and Injuries

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ovarian cystectomy

Procedure

Laparoscopic ovarian cystectomy using bipolar

Other names: laparoscopic ovarian cystectomy using bipolar

Primary outcomes

  1. Serum FSH and E2 assays

    Time frame: 12 months

Secondary outcomes

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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Shandong Provincial Hospital

Other Gov

Collaborators

  • Shandong University

Registry information

Official study title

The Impact of Electrocoagulation on Ovarian Reserve After Laparoscopic Exc

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Jul 11, 2008
Registry last updated
Aug 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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