Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy

Study Overview
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Brief Summary
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Endometriosis is a disease characterized by the presence of endometrial tissue outside the uterus cavity, causing important chronic pain and sterility in those patients suffering from it. It affects from 10 to 20% of women at reproductive age. Different types of endometriosis, which can coexist in the same patient, exist: deep infiltrating endometriosis (implants infiltrate > 5 mm the peritoneum), superficial endometriosis and ovarian endometriosis (OMA). OMA sometimes require surgery, and it is known that healthy ovarian tissue is also injured during resection. Consequently, ovarian reserve decreases, worsening the reproductive prognosis of patients affected. The main objective of the present study is to compare laser versus conventional OMA excision according to ovarian reserve in a pairwise-data study.

Official Title
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Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy

Conditions
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Endometriosis Ovary

Intervention / Treatment
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* Procedure: CO2 (carbon dioxide) laser vaporisation
* Procedure: Stripping technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 45. Bilateral endometriomas. Endometrioma size > 3 cm. Pain and/or infertility as indication to surgical treatment. Exclusion Criteria: History of cancer. Suspected malignancy. Evidence of premature ovarian failure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized prospective pairwise-data study. Patients with bilateral endometrioma with surgical indication will be selected. Ovarian reserve will be evaluated before and after surgery in both ovaries separately, using antral follicle count (AFC) and volume measurement. Type of surgery in each ovary will be randomized in the operating room (standard cystectomy vs laser vaporisation). A blinded ultrasonographer will evaluate AFC and volume measurement in both ovaries, before and three and six months after surgery. Therefore, each ovary will be compared with its contralateral in the same patient.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stripping technique<br>The endometrioma is removed according to standard surgery. | Procedure: Stripping technique<br>* Identification of a cleavage plane and perform the cystectomy removing all the wall of the endometrioma from the healthy ovarian tissue<br>|
| Experimental: Laser technique<br>The endometrioma is drained, everted and then the inner wall of the endometrioma is vaporised with CO2 laser | Procedure: CO2 (carbon dioxide) laser vaporisation<br>* CO2 (carbon dioxide) laser is used to vaporise the inner wall of the endometrioma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian reserve | Antral follicular count by ultrasound: number of antral follicles. | 7 months | 
| Ovarian volume | Ovarian volume will be assesses by ultrasound, units given with milliliters | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | Pregnancy rate will be recorded during the 6 months follow-up | 6 months after surgery |