Status:
ACTIVE_NOT_RECRUITING
IVF Versus Surgery for Endometriosis Related Infertility
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborating Sponsors:
IRCCS San Raffaele
ASST Fatebenefratelli Sacco
Conditions:
Endometriosis
Eligibility:
FEMALE
18-39 years
Phase:
NA
Brief Summary
The management of endometriosis-related infertility remains controversial. In particular, there is an equipoise for infertile women with endometriotic lesions detected at ultrasound. These women can b...
Detailed Description
Women accepting to enter the study will be randomized to either surgery and then natural pregnancy seeking or a program of three complete IVF cycles (i.e. three oocytes retrievals regardless of the nu...
Eligibility Criteria
Inclusion
- Age \< 40 years
- Pregnancy seeking for more than 12 months
- Regular menstrual cycle, i.e. mean cycle interval between 21 and 35 days
- Ultrasonographic diagnosis of ovarian endometriomas or deep peritoneal endometriosis.
- Normal seminal analysis based on WHO criteria
- Absence of ureteral stenosis or intestinal subocclusive symptoms
Exclusion
- Previous surgery for endometriosis
- Previous IVF cycles
- Contraindication to pregnancy
- Hydrosalpinx
- Endometriomas with a mean diameter \> 4 cm
- Submucosal fibroids or large intramural or subserosal fibroids (≥ 5 cm).
- Doubtful sonographic findings that do not allow to reliably rule out malignancy.
- Obstacles to regular sexual intercourses (sexual disturbances or logistic problems)
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT04743167
Start Date
March 16 2021
End Date
December 31 2025
Last Update
February 7 2025
Active Locations (3)
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1
ASST-FBF-Sacco, Presidio Ospedaliero Macedonio Melloni
Milan, MI, Italy, 20100
2
IRCCS San Raffaele
Milan, MI, Italy, 20100
3
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, MI, Italy, 20122