Status:
UNKNOWN
The Impact on Ovarian Reserve of Ovarian Cystectomy Versus Laser Vaporization in the Treatment of Ovarian Endometrioma: a Randomized Clinical Trial
Lead Sponsor:
Scientific Institute San Raffaele
Conditions:
Endometrioma
Eligibility:
FEMALE
20-39 years
Phase:
NA
Brief Summary
This is a prospective, multicentric (two centers: 1:San Raffaele Scientific institute, Milan, Italy; 2:Jagiellonian University, Collegium Medicum, Cracow, Poland), randomized (1:1) clinical trial that...
Detailed Description
Excisional surgery is the recommended treatment for ovarian endometrioma because of higher pregnancy rate and lower recurrence rate compared with ablative techniques. From the standpoint of ovarian re...
Eligibility Criteria
Inclusion
- unilateral or bilateral endometriomas
- pain and/or infertility associated with endometriomas
- largest diameter of the endometrioma ≥3 cm and ≤ 8 cm
Exclusion
- intra-operative detection of deep infiltrating endometriosis
- evidence of adenomyosis at the preoperative ultrasound
- previous surgical procedures on the ovaries
- previous unilateral oophorectomy
- previous salpingectomy or hysterectomy
- thyroid disease
- hyperprolactinemia
- diabetes mellitus
- adrenal disorders
- suspected or proven ovarian malignancy
- evidence of premature ovarian failure (POF) or premature menopause
- hormonal treatment within 3 months from baseline ovarian reserve assessment and 3 months after surgery.
Key Trial Info
Start Date :
January 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03227640
Start Date
January 1 2016
End Date
January 1 2018
Last Update
July 24 2017
Active Locations (2)
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1
San Raffaele Scientific Institute
Milan, Italy
2
Jagiellonian University, Collegium Medicum, Cracow, Poland
Krakow, Poland