An observational study in Gonadal Dysfunction, Gonadal Failure and Azoospermia, sponsored by Jumeirah American Clinic. Recruiting at 1 site in United Arab Emirates. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-04-10.
Sponsored by Jumeirah American Clinic · Observational
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.
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 hormonal deficiencies, significantly impacting an individual's health and quality of life. Conventional treatments such as hormone replacement therapy (HRT) help alleviate symptoms but do not restore fertility.
Surgical options (testicular sperm retrieval, ultrasound-guided egg retrieval) are found to be helpful for some. However, they are not uniformly successful 11. Surgeries (testicular biopsies) always carry risks such as risk of bleeding or infection and lack of guaranteed success 12. Clinicians are exploring less invasive alternatives like stem cell-based therapies, including adipose-derived stem cells (ADSCs) and exosomes. Stem cells or stem cell-derived exosome therapy offers a promising regenerative approach for restoring gonadal function by enhancing tissue repair, stimulating folliculogenesis or spermatogenesis, modulating hormonal balance, and improving overall reproductive potential in individuals with testicular or ovarian failure.
This study assesses the safety and efficacy of intra-gonadal (testicular or ovarian) stem cells or stem cell-derived exosome injection for patients with testicular and ovarian failure who have not responded to conventional treatments. ADSC therapy has been studied in humans for related conditions like ovarian insufficiency and POF (Premature ovarian failure)6. It has shown encouraging results in repairing damaged tissues and improving hormonal function, showing early successes that provide hope for its potential. This research assumes even greater importance in the UAE, where donor sperm and eggs are not permitted due to religious and legal restrictions 13. Testing the safety and long-term efficacy of ADSC therapy for gonadal failure in the UAE could provide a groundbreaking, culturally appropriate solution for individuals facing reproductive challenges, giving them new opportunities for treatment and a renewed sense of hope.
The Bioscience Institute, a DHA-approved facility, will provide the stem cells or stem cell-derived exosomes under an existing Memorandum of Understanding (MOU) with the First IVF Clinic and Day Surgery Center. The stem cells or stem cell-derived exosomes will be extracted and produced in an off-site laboratory (Bioscience Institute) and undergo sterility, cell count, and viability check before being prepared for administration back into the patient. The manufacturing process follows CGTP. The cells will be injected directly into the testes and ovaries under anesthesia.
Study Objectives
Primary Objective:
Secondary Objectives:
Study Design and Objectives This open-label, single-arm, pilot observational study will serve as a preliminary investigation into the use of adipose-derived stem cells (ADSCs) or stem cell-derived exosomes for treating gonadal failure in both men and women. The study's primary focus will be on assessing safety and feasibility, while also gathering initial efficacy data to support future large-scale trials.
Study Population The study will enroll 60 adults (30 males, 30 females) aged 20 to 50 years diagnosed with gonadal failure, including testicular failure, hypogonadism, ovarian insufficiency, or premature ovarian failure (POF). Participants must have failed or experienced suboptimal responses to conventional treatments, such as hormone replacement therapy (HRT), testosterone replacement therapy (TRT), or assisted reproductive technologies (ART).
Recruitment will take place at First IVF Clinic, Dubai, where participants are actively receiving evaluation and treatment for gonadal failure. The inclusion and exclusion criteria will ensure that the study targets individuals most likely to benefit from therapy while prioritizing patient safety.
Sample Size Rationale A sample size of 60 participants was selected based on the exploratory nature of the study. The primary objective is to assess the feasibility, safety, and preliminary efficacy of stem cell or exosome therapy while providing sufficient data to inform the design of future, larger trials. Given the clinic's patient population, recruiting 60 participants over the planned two-year study period is considered achievable.
Study Procedures
Baseline Assessments
Before treatment, participants will undergo comprehensive baseline testing, including:
Hormonal blood tests (Testosterone, Estradiol, FSH, AMH)
Ultrasound imaging (AFC for ovaries, testicular volume for testes)
Semen analysis (for male participants, if applicable)
Medical history review and general health evaluation
Therapeutic Administration
For ADSCs:
ADSCs will be harvested via minimally invasive liposuction from the participant's own adipose tissue.
The cells will be processed, purified, and prepared for injection into the ovaries (females) or testes (males).
For Exosomes:
Exosomes will be derived from stem cells, isolated, and purified before administration.
The injections will follow the same procedure as stem cell therapy, ensuring targeted delivery into the gonads.
Injection Procedure:
Ovarian injections: Administered via direct intraovarian injection. Testicular injections: Administered via direct intratesticular injection in rete testis.
Participants will be monitored immediately post-injection for any adverse reactions and will return for regular follow-ups at 3, 6, 9, and 12 months to assess:
Data Collection and Analysis Collected data will be analyzed to evaluate primary and secondary outcomes.
Primary Outcome:
Hormonal level changes from baseline to 12 months post-treatment.
Secondary Outcomes:
Changes in gonadal tissue structure (AFC, testicular volume). Functional improvements (spermatogenesis, menstrual cycle regulation). Incidence of adverse events (infection, fibrosis, immune response). Surgical sperm retrieval and Egg retrieval success
Ethical Considerations This study will adhere to strict ethical standards for clinical research.
Ethics Committee Review: The protocol will be reviewed and approved by an independent ethics board.
Informed Consent: Participants will have full autonomy to decide on participation and may withdraw at any time without affecting their standard medical care.
Confidentiality: All patient data will be anonymized and stored securely to ensure privacy.
Expected Outcomes
This study aims to provide early evidence on the safety and potential efficacy of stem cell or exosome therapy for gonadal failure. If successful, participants are expected to show:
Improvements in hormone levels and reproductive function. Gonadal tissue regeneration, restoring follicular activity or spermatogenesis. Minimal adverse effects, confirming safety and feasibility. The findings from this study will help guide future, larger-scale trials and contribute to the development of regenerative therapies for gonadal failure, offering a novel and culturally appropriate solution for fertility preservation in the UAE.
75 studies on the registry are indexed under Eunuchism; 21 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 17 observational studies indexed under Eunuchism.
Browse Eunuchism studies →Jumeirah American Clinic is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Compared within Eunuchism, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Gonadal Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The study population will consist of adult male and female patients aged 20 to 50 years who are diagnosed with testicular or ovarian failure and are seeking treatment at First IVF and Day Surgery Center. Participants will be recruited from the pool of patients under the care of the PI or the co-Is. Eligibility will include individuals with confirmed testicular or ovarian failure based on clinical, hormonal, and imaging criteria who have not responded adequately to conventional treatments such as hormone therapy (HT).
Male patients:
Female patients:
Exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Procedure: Stem cells
Female patients aged 20 to 50 years. Diagnosed with premature ovarian failure (POF) or ovarian insufficiency, confirmed through clinical, hormonal, and imaging assessments.
Procedure: Stem cells
The administration of stem cell or stem cell-derived exosome therapy as a regenerative treatment for gonadal failure in both men and women. The intervention involves a single intra-gonadal injection (testicular or ovarian) of adipose-derived stem cells (ADSCs) or exosomes.
Change in reproductive capacity
We will evaluate hormonal changes (testosterone, estradiol, FSH, AMH) and sperm parameters
Time frame: 12 months
Gonadal Function
Evaluate functional outcomes such as surgical sperm retrieval success and ovarian follicular activity in women (via antral follicle count and egg retrieval success)
Time frame: 12 months
Adverse Effects
Document any adverse events or complications related to stem cell or exosome therapy, such as fibrosis, infection, or immune reactions.
Time frame: 12 months
Plan to share: Yes — The study will involve the collection of individual participant data (IPD) related to adult male and female patients aged 20 to 50 years diagnosed with testicular or ovarian failure who are seeking treatment at First IVF and Day Surgery Center. The specific IPD that will be shared includes: De-identified Data to be Shared Demographic Data: Age, sex, and relevant medical history (without personal identifiers). Clinical Data: Diagnosis of testicular or ovarian failure, including clinical presentation and duration of symptoms. Hormonal and Imaging Data: Laboratory test results (e.g., hormone levels such as FSH, LH, testosterone, estrogen) and imaging findings confirming the diagnosis. Treatment and Response Data: Information on previous hormone therapy (HT) and response status. Outcome Measures: Treatment efficacy, adverse events, and follow-up assessments. Data Not to be Shared Personal identifiers such as names, contact details, and specific identifying information.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: May 2026 to May 2028
Access criteria: Upon formal request to PI
Started Apr 2025 (actual). Primary completion is estimated for Apr 2027, 24 months after the start.
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Jumeirah American Clinic