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NCT Number: NCT02350452

Impact on Ovarian Reserve of Diode Laser vs Bipolar Coagulation of Endometriomas

Endometriosis is a benign chronic gynaecological disease that affects 10% of women of reproductive age and takes 40% of them to assisted reproduction techniques.

The purpose of the study is to compare the antimüllerian marker (AMH) and antral follicular count (AFC) , with the most common serological markers of ovarian reserve. The investigators intend to confirm their clinical utility in the assessment of ovarian function, and to promote their use in predicting decreased ovarian reserve.

The work therefore moreover arises the objective to validate the bibliographic data about using the laser for haemostasis after stripping endometriomas, to amplify knowledge available in the literature on the surgical treatment of ovarian endometriomas and on the diode laser application in minimally invasive surgery, appraising the trend of AFC and AMH levels and the possible surgical implications on fertility .

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Key information

Conditions

Ovarian Endometrioma Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Cagliari,Obstetrics and Gynecological Department,

Monserrato, Cagliari, 09042, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • regular menstrual cycles
  • unilateral endometrioma greater than 35 mm
  • no gynecological surgery 3-6 months before surgery
  • no hormonal therapy 1 month before surgery

Exclusion criteria

  • previous surgery for endometriosis
  • hormone therapy in the month before the current surgery
  • coagulation disorders
  • ongoing pregnancy
  • pelvic inflammatory disease
  • malignant disorders
  • cysts otherwise
  • Gonadotropin-releasing hormone analogues or contraceptive therapy during the follow-up
  • BMI≥ 30 kg/m2
  • endocrinological disorders
  • unable or unwilling to give written consent

Treatment and study plan

Diode laser coagulation

Procedure

Diode laser coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy

Bipolar coagulation

Procedure

Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy

Primary outcomes

  1. Anti-Müllerian hormone (AMH) serum levels

    Time frame: Change from AMH serum levels at 3 months after surgery

Secondary outcomes

  1. Antral follicular count (AFC)

    Time frame: Change from AFC at 3 months after surgery, during early follicular phase

Sponsors and collaborators

Lead sponsor

University of Cagliari

Other

Collaborators

  • University of Foggia

Registry information

Official study title

The Impact on Ovarian Reserve of Diode Laser vs Bipolar Coagulation of Inner Lining of Ovarian Endometriomas After Laparoscopic Cystectomy: a Randomized Clinical Trial.

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Jan 29, 2015
Registry last updated
Apr 22, 2016

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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