Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes

Recruiting now

Conditions studied: Gonadal Dysfunction, Gonadal Failure, Azoospermia, Testosterone Deficiency, Stem Cells, Hypogonadism, Male

In brief

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.

Key facts

Study ID: NCT06841328
Run by: Jumeirah American Clinic
People needed: 60
Starts: 2025-04-08
Expected to finish: 2028-04-30
Last updated by the study team: 2025-04-10

Who can join

Age: 20 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

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 or trauma that could interfere with the study outcomes.
Use of anticoagulants or medications that may contraindicate stem cell or stem cell-derived exosome therapy.
Participation in another investigational drug or treatment study within the past 6 months.
Contraindications to stem cell or stem cell-derived exosome therapy, such as immune deficiencies or allergies to any treatment components.
Severe neurological disorders or cognitive impairment may limit the ability to provide informed consent or follow study instructions.
Any condition that, in the investigator's opinion, could interfere with the study or pose an undue risk to the patient.
Women with a primary diagnosis of psychogenic ovarian dysfunction or infertility.
History of ovarian surgery or trauma that could interfere with the study outcomes.

Where it is running

First IVF and Day Surgery Center — Dubai, Dubai, United Arab Emirates (enrolling)

Full record on ClinicalTrials.gov

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