Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes (NCT06841328) | Clinical Trial Compass
RecruitingNot Applicable
Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes
United Arab Emirates60 participantsStarted 2025-04-08
Plain-language 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.
Who can participate
Age range20 Years – 50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Male patients:
* Male patients aged 20 to 50 years.
* Diagnosed with testicular failure (low testosterone) or hypogonadism (impaired gonadal function), or azoospermia (no sperm in ejaculate)
* Suboptimal response to conventional treatments, such as testosterone replacement therapy (TRT) or fertility-enhancing medications (Clomiphene citrate or anastrozole).
* General good health without significant contraindications to stem cell or stem cell-derived exosome therapy.
* Willing and able to provide informed consent and comply with the study protocol.
* Patients who have been evaluated for testicular failure and are seeking further treatment.
Female patients:
* Female patients aged 20 to 50 years.
* Diagnosed with premature ovarian failure (POF) or ovarian insufficiency, confirmed through clinical, hormonal, and imaging assessments.
* Failure or suboptimal response to conventional treatments, such as hormone therapy.
* General good health without significant contraindications to stem cell or stem cell-derived exosome therapy.
* Willing and able to provide informed consent and comply with the study protocol.
* Patients who have been evaluated for ovarian failure are seeking further treatment.
Exclusion criteria
* Severe comorbid conditions, such as advanced cardiovascular disease, renal failure, or uncontrolled diabetes.
* Active malignancies or history of cancer within the past 5 years.
* Active infections or systemic inflammatory conditions.
* History of testicular surgery …