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

April 21, 2016 updated by: Stefano Angioni, University of Cagliari

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

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Cagliari
      • Monserrato, Cagliari, Italy, 09042
        • University of Cagliari,Obstetrics and Gynecological Department,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diode laser coagulation
Diode laser coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy
Procedure: Diode laser coagulation
Diode laser coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy
Active Comparator: Bipolar coaugulation
Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy
Procedure: Bipolar coagulation
Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti-Müllerian hormone (AMH) serum levels
Time Frame: Change from AMH serum levels at 3 months after surgery
Change from AMH serum levels at 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Antral follicular count (AFC)
Time Frame: Change from AFC at 3 months after surgery, during early follicular phase
Change from AFC at 3 months after surgery, during early follicular phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cagliari

Collaborators

University of Foggia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

January 25, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Estimate)

April 22, 2016

Last Update Submitted That Met QC Criteria

April 21, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENDOLASER01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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