Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy
Primary Purpose
Endometriosis Ovary
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CO2 (carbon dioxide) laser vaporisation
Stripping technique
Sponsored by
About this trial
This is an interventional treatment trial for Endometriosis Ovary
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Stripping technique
Laser technique
Arm Description
The endometrioma is removed according to standard surgery.
The endometrioma is drained, everted and then the inner wall of the endometrioma is vaporised with CO2 laser
Outcomes
Primary Outcome Measures
Ovarian reserve
Antral follicular count by ultrasound: number of antral follicles.
Ovarian volume
Ovarian volume will be assesses by ultrasound, units given with milliliters
Secondary Outcome Measures
Pregnancy rate
Pregnancy rate will be recorded during the 6 months follow-up
Full Information
NCT ID
NCT03826355
First Posted
January 20, 2019
Last Updated
January 30, 2019
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT03826355
Brief Title
Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy
Official Title
Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis Ovary
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigator
Masking Description
The ultrasonographer will be blinded to the procedure performed in each ovary after surgery. The patient will not be told which procedure has been performed in each ovary. The investigator will not know which procedure has been performed in each ovary until the end of the study. Only the surgeon will know which procedure is performed in each ovary.
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stripping technique
Arm Type
Active Comparator
Arm Description
The endometrioma is removed according to standard surgery.
Arm Title
Laser technique
Arm Type
Experimental
Arm Description
The endometrioma is drained, everted and then the inner wall of the endometrioma is vaporised with CO2 laser
Intervention Type
Procedure
Intervention Name(s)
CO2 (carbon dioxide) laser vaporisation
Intervention Description
CO2 (carbon dioxide) laser is used to vaporise the inner wall of the endometrioma
Intervention Type
Procedure
Intervention Name(s)
Stripping technique
Intervention Description
Identification of a cleavage plane and perform the cystectomy removing all the wall of the endometrioma from the healthy ovarian tissue
Primary Outcome Measure Information:
Title
Ovarian reserve
Description
Antral follicular count by ultrasound: number of antral follicles.
Time Frame
7 months
Title
Ovarian volume
Description
Ovarian volume will be assesses by ultrasound, units given with milliliters
Time Frame
7 months
Secondary Outcome Measure Information:
Title
Pregnancy rate
Description
Pregnancy rate will be recorded during the 6 months follow-up
Time Frame
6 months after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco Carmona, MD PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact on Ovarian Reserve According to the Type of Ovarian Endometrioma Excision: Laser Versus Conventional Cystectomy
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