Actively Recruiting
Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes
Led by Jumeirah American Clinic · Updated on 2025-04-10
60
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 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.
CONDITIONS
Official Title
Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 20 to 50 years
- Diagnosed with testicular failure (low testosterone), hypogonadism, or azoospermia
- Suboptimal response to testosterone replacement therapy or fertility medications like Clomiphene citrate or anastrozole
- Generally good health without major contraindications to stem cell or exosome therapy
- Willing and able to give informed consent and follow the study plan
- Evaluated for testicular failure and seeking further treatment
- Female patients aged 20 to 50 years
- Diagnosed with premature ovarian failure or ovarian insufficiency confirmed by clinical, hormonal, and imaging tests
- Failure or poor response to hormone therapy
- Generally good health without major contraindications to stem cell or exosome therapy
- Willing and able to give informed consent and follow the study plan
- Evaluated for ovarian failure and seeking further treatment
You will not qualify if you...
- Severe health conditions like advanced heart disease, kidney failure, or uncontrolled diabetes
- Active cancer or cancer history in the past 5 years
- Active infections or systemic inflammatory diseases
- Previous testicular or ovarian surgery or trauma that may affect study results
- Use of blood thinners or medications that conflict with stem cell or exosome therapy
- Participation in another investigational treatment study within the past 6 months
- Contraindications such as immune deficiencies or allergies to treatment components
- Severe neurological or cognitive disorders limiting consent or study compliance
- Any condition that may interfere with the study or increase risk as judged by the investigator
- Women with psychogenic ovarian dysfunction or infertility
- History of ovarian surgery or trauma affecting study outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
First IVF and Day Surgery Center
Dubai, Dubai, United Arab Emirates
Actively Recruiting
Research Team
R
Ranjith Ramasamy, MD
CONTACT
S
Sheila May, RN
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here