Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes
FERTILE
1 other identifier
observational
60
1 country
1
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2025
CompletedFirst Posted
Study publicly available on registry
February 24, 2025
CompletedStudy Start
First participant enrolled
April 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2028
April 10, 2025
April 1, 2025
2.1 years
February 18, 2025
April 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in reproductive capacity
We will evaluate hormonal changes (testosterone, estradiol, FSH, AMH) and sperm parameters
12 months
Secondary Outcomes (1)
Gonadal Function
12 months
Other Outcomes (1)
Adverse Effects
12 months
Study Arms (2)
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)
Female
Female patients aged 20 to 50 years. Diagnosed with premature ovarian failure (POF) or ovarian insufficiency, confirmed through clinical, hormonal, and imaging assessments.
Interventions
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.
Eligibility Criteria
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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First IVF and Day Surgery Center
Dubai, Dubai, United Arab Emirates
Related Publications (1)
Zafardoust S, Kazemnejad S, Darzi M, Fathi-Kazerooni M, Rastegari H, Mohammadzadeh A. Improvement of Pregnancy Rate and Live Birth Rate in Poor Ovarian Responders by Intraovarian Administration of Autologous Menstrual Blood Derived- Mesenchymal Stromal Cells: Phase I/II Clinical Trial. Stem Cell Rev Rep. 2020 Aug;16(4):755-763. doi: 10.1007/s12015-020-09969-6.
PMID: 32198596BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ranjith Ramasamy, MD
Jumeirah American Clinic
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Urologist
Study Record Dates
First Submitted
February 18, 2025
First Posted
February 24, 2025
Study Start
April 8, 2025
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2028
Last Updated
April 10, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- May 2026 to May 2028
- Access Criteria
- Upon formal request to PI
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: 1. 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. 2. Data Not to be Shared Personal identifiers such as names, contact details, and specific identifying information.