Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes
Key facts
- Who runs it
- Jumeirah American Clinic
- Where
- United Arab Emirates1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- People taking part
- 60 people, planned
- Started
- 8 Apr 2025
- Expected to end
- 30 Apr 2028
- Type of study
- Observational, 2 groups
- Treatments tested
- Stem cells
- Record updated
- 10 April 2025
Who can take part
- Age
- 20 years to 50 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 24 criteriaShow less
Who cannot take part
- 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
- 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
- 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
- History of ovarian surgery or trauma that could interfere with the study outcomes
- Women with a primary diagnosis of psychogenic ovarian dysfunction or infertility
Other 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 20 and 50 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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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 permitted.
By bridging the gap between preclinical research and clinical application, this study could offer new hope to individuals with gonadal failure, advancing the field of regenerative reproductive medicine.
The 2 groups in the trial
- Male
Male patients aged 20 to 50 years. Diagnosed with testicular failure (low testosterone) or hypogonadism (impaired gonadal function), or azoospermia due to production defect (no sperm in ejaculate)
Treatment: Stem cells
- Female
Female patients aged 20 to 50 years. Diagnosed with premature ovarian failure (POF) or ovarian insufficiency, confirmed through clinical, hormonal, and imaging assessments.
Treatment: Stem cells
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes: (FERTILE): Prospective Observational Study Evaluating Safety and Efficacy
- Fit questions
- Built from NCT06841328, who can take part
- Record updated
- 10 April 2025