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Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes

NCT06841328 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-04-10

No results posted yet for this study

Summary

This study investigates the safety and efficacy of stem cell or stem cell-derived exosome therapy for gonadal failure, including testicular failure, hypogonadism, ovarian insufficiency, and premature ovarian failure (POF). Conducted at First IVF Clinic, Dubai, it will include 60 participants (30 males, 30 females) aged 20-50 years who have not responded to conventional treatments such as HRT, TRT, or ART.

Participants will receive intra-gonadal (testicular or ovarian) injections of stem cells or exosomes, with follow-ups at 3, 6, 9, and 12 months to monitor hormonal changes, gonadal function, and potential adverse effects. The study aims to determine whether regenerative therapy can restore hormone production, enhance reproductive function, and regenerate gonadal tissue, providing a novel, culturally appropriate fertility treatment in the UAE, where donor sperm and eggs are not permitted.

By bridging the gap between preclinical research and clinical application, this study could offer new hope to individuals with gonadal failure, advancing the field of regenerative reproductive medicine.

Conditions

  • Gonadal Dysfunction
  • Gonadal Failure
  • Azoospermia
  • Testosterone Deficiency
  • Stem Cells
  • Hypogonadism, Male

Interventions

PROCEDURE

Stem cells

The administration of stem cell or stem cell-derived exosome therapy as a regenerative treatment for gonadal failure in both men and women. The intervention involves a single intra-gonadal injection (testicular or ovarian) of adipose-derived stem cells (ADSCs) or exosomes.

Sponsors & Collaborators

  • Jumeirah American Clinic

    lead OTHER

Principal Investigators

  • Ranjith Ramasamy, MD · Jumeirah American Clinic

Eligibility

Min Age
20 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-08
Primary Completion
2027-04-30
Completion
2028-04-30

Countries

  • United Arab Emirates

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 NCT06841328 on ClinicalTrials.gov