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

Primary Purpose

Ovarian Endometrioma

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Diode laser coagulation
Bipolar coagulation
Sponsored by
University of Cagliari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Endometrioma focused on measuring laparoscopic surgery, diode laser, AMH, AFC

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • University of Cagliari,Obstetrics and Gynecological Department,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diode laser coagulation

Bipolar coaugulation

Arm Description

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

Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy

Outcomes

Primary Outcome Measures

Anti-Müllerian hormone (AMH) serum levels

Secondary Outcome Measures

Antral follicular count (AFC)

Full Information

First Posted
January 19, 2015
Last Updated
April 21, 2016
Sponsor
University of Cagliari
Collaborators
University of Foggia
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1. Study Identification

Unique Protocol Identification Number
NCT02350452
Brief Title
Impact on Ovarian Reserve of Diode Laser vs Bipolar Coagulation of Endometriomas
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cagliari
Collaborators
University of Foggia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Endometrioma
Keywords
laparoscopic surgery, diode laser, AMH, AFC

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diode laser coagulation
Arm Type
Experimental
Arm Description
Diode laser coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy
Arm Title
Bipolar coaugulation
Arm Type
Active Comparator
Arm Description
Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy
Intervention Type
Procedure
Intervention Name(s)
Diode laser coagulation
Intervention Description
Diode laser coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy
Intervention Type
Procedure
Intervention Name(s)
Bipolar coagulation
Intervention Description
Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy
Primary Outcome Measure Information:
Title
Anti-Müllerian hormone (AMH) serum levels
Time Frame
Change from AMH serum levels at 3 months after surgery
Secondary Outcome Measure Information:
Title
Antral follicular count (AFC)
Time Frame
Change from AFC at 3 months after surgery, during early follicular phase

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Cagliari,Obstetrics and Gynecological Department,
City
Monserrato
State/Province
Cagliari
ZIP/Postal Code
09042
Country
Italy

12. IPD Sharing Statement

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

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