Status:
RECRUITING
Investigation of Copy Number Variations and Genetic Variants in POI
Lead Sponsor:
Ospedale Policlinico San Martino
Conditions:
Primary Ovarian Insufficiency
Eligibility:
FEMALE
15-38 years
Brief Summary
Primary ovarian insufficiency (POI), also known as premature ovarian failure, is an ovarian defect characterized by the premature (before the age of 40 years) depletion of ovarian follicles. POI affec...
Detailed Description
Although in the last decades an increasing number of aberrant genes involved in POI were identified, currently only a minority of affected women can be explained at gene level. Elucidating the biology...
Eligibility Criteria
Inclusion
- age at diagnosis \<38 years;
- a normal 46,XX karyotype (no FRM1 premutation);
- at least one marker of ovarian reserve not age-appropriate:
- baseline FSH levels \> cut-off \[1\] and/or
- age-specific AMH \< cut-off \[2\] and/or
- AFC \< 5; and/or
- cancellation of a PMA cycle because of poor response (\<3 follicles) to high-dose gonadotrophins (250 U/die) and/or
- retrieval of \< 4 oocytes in response to high-dose stimulation protocols (3000 U of gonadotrophins).
Exclusion
- patients with POI-related conditions, such as ovarian surgery or previous chemo- or radio-therapy; endometriosis or known autoimmune or metabolic diseases.
Key Trial Info
Start Date :
January 31 2012
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05327283
Start Date
January 31 2012
End Date
December 31 2030
Last Update
April 25 2022
Active Locations (1)
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1
UOS Fisiopatologia della Riuproduzione Umana
Genova, Italy