RecruitingNCT06841328

Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes

Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes: (FERTILE): Prospective Observational Study Evaluating Safety and Efficacy

Sponsor

Jumeirah American Clinic

Enrollment

60 participants

Start Date

Apr 8, 2025

Study Type

OBSERVATIONAL

Conditions

Hypogonadism, Male Testosterone Deficiency Gonadal Dysfunction Gonadal Failure Azoospermia Stem Cells

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.

Eligibility

Min Age: 20 YearsMax Age: 50 Years

Inclusion Criteria14

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 Criteria11

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.

Interventions

PROCEDUREStem 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.