Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy (UB-OVF)

Ukraine Association of Biobank

Status: Completed

Conditions: Primary Ovarian Insufficiency; Premature Ovarian Failure

Treatments: Other: Observational

Study type: Observational

Funder types: Other

Identifiers

NCT04675970

UAB1220-2

Details and patient eligibility

About

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

Enrollment: 86 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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 criteria

There are no exclusion criteria for this study