💬In plain words
What the trial is, and whether it could suit you
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 permitte
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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