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

NCT04675970 | Completed

• 1 other identifier: UAB1220-2
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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

Conditions

Primary Ovarian Insufficiency; Premature Ovarian Failure

Keywords

Premature ovarian failure; stem cell therapy; mesenchymal stem cell

Outcome Measures

Primary Outcomes (2)

• Antral follicular count (AFC) serum levels

  Antral follicular count (AFC) \<5-7 follicles

  2 years

• anti-Müllerian hormone (AMH) serum levels

  AMH \<0.5-1.1 ng/ml

  2 years

Secondary Outcomes (1)

• Regular menstruation and/or pregnancy

  2 years

Interventions

Observational OTHER

Product in a Institute of Bio-Stem Cell rehabilitation UAB - sponsored clinical trial who agree to participate in this study

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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)

Sponsors & Collaborators

• Ukraine Association of Biobank: lead

Study Sites (1)

Institute of Bio-Stem Cell Rehabilitation

Kharkiv, Ukraine

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 19, 2020
• Study Start: September 1, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2025
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

UA (1)