RecruitingNCT06841328

Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes

Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes: (FERTILE): Prospective Observational Study Evaluating Safety and Efficacy

Sponsor

Jumeirah American Clinic

Enrollment

60 participants

Start Date

Apr 8, 2025

Study Type

OBSERVATIONAL

Conditions

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

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.

Eligibility

Min Age: 20 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether stem cell-derived treatments (using stem cells or exosomes — tiny cellular messengers) can help restore fertility in men and women with conditions like testicular failure, premature ovarian failure, or very low sperm counts who have not responded well to conventional fertility treatments. **You may be eligible if...** - You are between 20 and 50 years old - For men: You have testicular failure, low testosterone, or no sperm (azoospermia) and have not responded to standard treatments - For women: You have been diagnosed with premature ovarian failure or ovarian insufficiency confirmed through tests - You are in generally good health without major contraindications **You may NOT be eligible if...** - You have conditions that would make stem cell therapy unsafe - You have not tried conventional treatments first - You have active serious infections or systemic diseases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREStem 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.