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

Ovarian Endometrioma Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02350452
• Other study ID #: ENDOLASER01
• Status: Recruiting
• Phase: N/A
• First received: January 19, 2015
• Last updated: March 8, 2016
• Start date: January 2015
• Est. completion date: June 2017

Study information

• Verified date: March 2016
• Source: University of Cagliari
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis
• Ovarian Endometrioma

Intervention

Procedure:
• Diode laser coagulation
Diode laser coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy
• Bipolar coagulation
Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy

Locations

Country	Name	City	State
Italy	University of Cagliari,Obstetrics and Gynecological Department,	Monserrato	Cagliari

Sponsors (2)

Lead Sponsor	Collaborator
University of Cagliari	University of Foggia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Müllerian hormone (AMH) serum levels		Change from AMH serum levels at 3 months after surgery	No
Secondary	Antral follicular count (AFC)		Change from AFC at 3 months after surgery, during early follicular phase	No