Enhancing fertility using stem cell therapy for gonadal dysfunction
Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes: (FERTILE): Prospective Observational Study Evaluating Safety and Efficacy
Jumeirah American Clinic · NCT06841328
This study is testing if stem cell therapy can help people with gonadal failure, like testicular or ovarian issues, improve their hormone levels and fertility when other treatments haven't worked.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | All |
| Sponsor | Jumeirah American Clinic (other) |
| Locations | 1 site (Dubai, Dubai) |
| Trial ID | NCT06841328 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of stem cell or stem cell-derived exosome therapy for individuals experiencing gonadal failure, including conditions like testicular failure and premature ovarian failure. Conducted at the First IVF Clinic in Dubai, it will enroll 60 participants aged 20-50 who have not responded to conventional treatments. Participants will receive intra-gonadal injections of stem cells or exosomes, with follow-ups at 3, 6, 9, and 12 months to monitor hormonal changes and gonadal function. The aim is to determine if regenerative therapy can restore hormone production and enhance reproductive function.
Who should consider this trial
Good fit: Ideal candidates include males aged 20-50 with testicular failure or hypogonadism and females aged 20-50 with premature ovarian failure who have not responded to conventional treatments.
Not a fit: Patients with significant contraindications to stem cell therapy or those who have not been diagnosed with gonadal dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel fertility treatment option for patients with gonadal dysfunction who have not benefited from traditional therapies.
How similar studies have performed: While stem cell therapies for related conditions have shown promise, this specific approach is relatively novel and has not been extensively tested in clinical settings.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Dubai, Dubai
- First IVF and Day Surgery Center — Dubai, Dubai, United Arab Emirates (RECRUITING)
Study contacts
- Principal investigator: Ranjith Ramasamy, MD — Jumeirah American Clinic
- Study coordinator: Ranjith Ramasamy, MD
- Email: ranjith.ramasamy@jac.ae
- Phone: +971 4 770 1741
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Gonadal Dysfunction, Gonadal Failure, Azoospermia, Testosterone Deficiency, Stem Cells, Hypogonadism, Male, Premature Ovarian Failure, Testicular Failure