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

NCT ID: NCT02350452

Last Updated: 2016-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-02-29

Brief Summary

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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 .

Detailed Description

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Conditions

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Ovarian Endometrioma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diode laser coagulation

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

Group Type EXPERIMENTAL

Diode laser coagulation

Intervention Type PROCEDURE

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

Bipolar coaugulation

Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy

Group Type ACTIVE_COMPARATOR

Bipolar coagulation

Intervention Type PROCEDURE

Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy

Interventions

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Diode laser coagulation

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

Intervention Type PROCEDURE

Bipolar coagulation

Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Foggia

OTHER

Sponsor Role collaborator

University of Cagliari

OTHER

Sponsor Role lead

Responsible Party

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Stefano Angioni

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Cagliari,Obstetrics and Gynecological Department,

Monserrato, Cagliari, Italy

Site Status

Countries

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Italy

Other Identifiers

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ENDOLASER01

Identifier Type: -

Identifier Source: org_study_id

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