Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes

Launched by JUMEIRAH AMERICAN CLINIC · Feb 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment using stem cells to help people with certain fertility problems. It focuses on individuals who have gonadal dysfunction, which means their reproductive organs (ovaries or testes) are not working properly. This includes men with low testosterone or no sperm and women with conditions like premature ovarian failure. The trial is looking for 60 participants, both men and women aged 20 to 50, who have not had success with traditional treatments like hormone therapy.

Participants in the trial will receive injections of either stem cells or exosome therapy directly into their reproductive organs. They will be monitored over the next year to see if this treatment improves hormone levels and overall reproductive function. It’s important to note that this study is taking place in Dubai, where traditional donor sperm and egg options are not available. For those who qualify and are interested, this trial could offer a new hope for restoring fertility and is designed to be culturally appropriate in the UAE.

Gender

ALL

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.