Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy

Active, not recruiting

• Conditions: Primary Ovarian Insufficiency; Premature Ovarian Failure

• Registration Number: NCT04675970
• Lead Sponsor: Ukraine Association of Biobank

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, 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

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-12-13
• Study First Submitted QC: 2020-12-17
• Study First Posted: 2020-12-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-09
• Primary Completion: 2024-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 86

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
anti-Müllerian hormone (AMH) serum levels	2 years	AMH \<0.5-1.1 ng/ml
Antral follicular count (AFC) serum levels	2 years	Antral follicular count (AFC) \<5-7 follicles

Secondary Outcome Measures

Name	Time	Method
Regular menstruation and/or pregnancy	2 years	regular menstruation for 5 months and\\or pregnancy

Trial Locations

Locations (1)

Institute of Bio-Stem Cell Rehabilitation; 🇺🇦 Kharkov, Ukraine