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
Study Type
OBSERVATIONAL
Enrollment
86
Product in a Institute of Bio-Stem Cell rehabilitation UAB - sponsored clinical trial who agree to participate in this study
Institute of Bio-Stem Cell Rehabilitation
Kharkiv, Ukraine
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
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