Enhancing fertility using stem cell therapy for gonadal dysfunction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.