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

NCT04675970 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 86

Last updated 2025-12-22

No results posted yet for this study

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

Interventions

OTHER

Observational

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

Sponsors & Collaborators

  • Ukraine Association of Biobank

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2024-09-30
Completion
2025-09-30

Countries

  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04675970 on ClinicalTrials.gov