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Investigation of Copy Number Variations and Genetic Variants in POI

Recruitingn/aAges 15 Years - 38 YearsFemaleOspedale Policlinico San Martino
NCT05327283 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 affects about 1% of women, reaching 30% in some familial cases. This heterogeneous disorder is characterized by progressive cessation of the ovarian function with temporary or intermittent amenorrhea associated with elevated serum FSH concentration and low AMH dosage. Low serum AMH dosage is able to detect a diminished ovarian pool occurring before the onset of FSH elevation and the ultimate deficiency leading to amenorrhea. POI causes infertility and a poor ovarian response in IVF stimulations, and it has important health consequences for affected patients, including psychological distress, infertility, osteoporosis, autoimmune disorders, ischaemic heart disease. Although the cause of POI rem

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * patients with POI-related conditions, such as ovarian surgery or previous chemo- or radio-therapy; endometriosis or known autoimmune or metabolic diseases.
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What it tests

  • Not listed
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Where

1 site
UOS Fisiopatologia della Riuproduzione Umana
Genova, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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