Status:
RECRUITING
Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes
Lead Sponsor:
Jumeirah American Clinic
Conditions:
Gonadal Dysfunction
Gonadal Failure
Eligibility:
All Genders
20-50 years
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 ...
Detailed Description
Background and Rationale: Testicular and ovarian failure, often called 'gonadal failure,' occurs when the testes or ovaries lose their ability to produce gametes. Both lead to reduced fertility and h...
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.
Key Trial Info
Start Date :
April 8 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 30 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06841328
Start Date
April 8 2025
End Date
April 30 2028
Last Update
April 10 2025
Active Locations (1)
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1
First IVF and Day Surgery Center
Dubai, Dubai, United Arab Emirates