Status:
COMPLETED
Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy
Lead Sponsor:
Ukraine Association of Biobank
Conditions:
Primary Ovarian Insufficiency
Premature Ovarian Failure
Eligibility:
FEMALE
18-40 years
Brief Summary
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, hypergonadotro...
Eligibility Criteria
Inclusion
- 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:
- Women age of 18 to 40 years
- Have experienced 4 months of oligo/amenorrhea
- Two serum follicle-stimulating hormone (FSH was \>40 mIU/ml levels in the menopausal range, obtained at least a month apart
- lower FSH levels ( 25 mIU/ml)
- anti-Müllerian hormone (AMH) serum levels ( 3.0 ng/ml)
Exclusion
- There are no exclusion criteria for this study
Key Trial Info
Start Date :
September 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 30 2025
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT04675970
Start Date
September 1 2020
End Date
September 30 2025
Last Update
December 22 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute of Bio-Stem Cell Rehabilitation
Kharkiv, Ukraine