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Completed

NCT Number: NCT04675970

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

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

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Key information

Conditions

Primary Ovarian Insufficiency Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Premature Ovarian Failure Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Institute of Bio-Stem Cell Rehabilitation

Kharkiv, Ukraine

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

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

Primary outcomes

  1. Antral follicular count (AFC) serum levels

    Time frame: 2 years

    Antral follicular count (AFC) <5-7 follicles

  2. anti-Müllerian hormone (AMH) serum levels

    Time frame: 2 years

    AMH <0.5-1.1 ng/ml

Secondary outcomes

  1. Regular menstruation and/or pregnancy

    Time frame: 2 years

    regular menstruation for 5 months and\\or pregnancy

Sponsors and collaborators

Lead sponsor

Ukraine Association of Biobank

Other

Registry information

Official study title

Long Term Follow up Patients With Premature Ovarian Failure ex Vivo Gene Therapy Using Autologous Mesenchymal Stem Cell and Mesenchymal Stem Cell Lyophilisate

Acronym: UB-OVF

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Dec 19, 2020
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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