NCT06841328 Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes
| NCT ID | NCT06841328 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jumeirah American Clinic |
| Condition | Gonadal Dysfunction |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-08 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-04-08 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 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.
Contact & Investigator
Ranjith Ramasamy, MD
PRINCIPAL INVESTIGATOR
Jumeirah American Clinic
Frequently Asked Questions
Who can join the NCT06841328 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 50 Years, studying Gonadal Dysfunction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06841328 currently recruiting?
Yes, NCT06841328 is actively recruiting participants. Contact the research team at ranjith.ramasamy@jac.ae for enrollment information.
Where is the NCT06841328 trial being conducted?
This trial is being conducted at Dubai, United Arab Emirates.
Who is sponsoring the NCT06841328 clinical trial?
NCT06841328 is sponsored by Jumeirah American Clinic. The principal investigator is Ranjith Ramasamy, MD at Jumeirah American Clinic. The trial plans to enroll 60 participants.