An observational study in Primary Ovarian Insufficiency and Premature Ovarian Failure, sponsored by Ukraine Association of Biobank. Completed at 1 site in Ukraine. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by Ukraine Association of Biobank · Observational
This is a multi-centers of long term safety and efficacy follow up study for patients with premature ovarian failure (the women aged younger than 40 years, who present with amenorrhoea, hypergonadotropic hypogonadism, and infertility) who have been treated with ex vivo gene therapy drug product in Institute of Bio-Stem Cell Rehabilitation UAB - sponsored clinical studies. After completing the parent clinical study (approximately 6 month), eligible subject will be followed for additional 2 years for total of 2 years and 6 month post drug product infusion. No investigation drug product will be administered in the study
172 studies on the registry are indexed under Primary Ovarian Insufficiency; 45 are open to participants now.
This study's enrollment of 86 is below the median of 100 across 59 observational studies indexed under Primary Ovarian Insufficiency.
Browse Primary Ovarian Insufficiency studies →Ukraine Association of Biobank is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with premature ovarian insufficiency (Diagnostic criteria of ESHRE) who have been treated with ex vivo gene therapy product in a Institute Bio-Stem Cell Rehabilitation UAB clinical study.
Provision of written informed consent for this study by subjects or as applicable parent legal guardian. Treated with drug product for therapy of premature ovarian insufficiency in a Institute Bio-Stem Cell Rehabilitation UAB clinical study.
Diagnosed of premature ovarian insufficiency ESHRE:
Exclusion Criteria:
There are no exclusion criteria for this study
Product in a Institute of Bio-Stem Cell rehabilitation UAB - sponsored clinical trial who agree to participate in this study
Antral follicular count (AFC) serum levels
Antral follicular count (AFC) \<5-7 follicles
Time frame: 2 years
anti-Müllerian hormone (AMH) serum levels
AMH \<0.5-1.1 ng/ml
Time frame: 2 years
Regular menstruation and/or pregnancy
regular menstruation for 5 months and\\or pregnancy
Time frame: 2 years
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Primary Ovarian Insufficiency→
Ukraine Association of Biobank