Actively Recruiting

Age: 20Years - 50Years
All Genders
ID06841328

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

Led by Jumeirah American Clinic · Updated on 2025-04-10

60

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of stem cell or stem cell-derived exosome therapy for people with gonadal failure, which includes testicular failure, hypogonadism, ovarian insufficiency, and premature ovarian failure (POF). The study focuses on adults aged 20 to 50 who have not responded well to usual treatments like hormone replacement therapy or assisted reproductive technologies. It aims to explore whether this regenerative treatment can restore hormone production and improve reproductive function, especially in a region where donor sperm and eggs are not allowed. Participants will receive a single injection of adipose-derived stem cells or exosomes directly into their testes or ovaries under anesthesia. The stem cells or exosomes are prepared in a specialized lab and checked for safety and quality before administration. This open-label pilot study includes 60 participants, divided equally between men and women. Follow-up visits occur at 3, 6, 9, and 12 months after treatment to track changes in hormone levels, gonadal function, and reproductive capacity. During the study, participants will have blood tests to measure hormones like testosterone and estradiol, imaging scans to assess gonadal tissue, and semen analysis for men. Researchers will monitor for any side effects or complications, including infections or immune reactions. The main outcome is the change in reproductive capacity after 12 months. Data collected will help guide future larger trials and contribute to developing new fertility treatments using regenerative medicine.

CONDITIONS

Brief Title

Fertility Enhancement Through Regenerative Treatment in Ovaries and Testes

Who Can Participate

Age: 20Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients aged 20 to 50 years
  • Male patients diagnosed with testicular failure, hypogonadism, or azoospermia
  • Female patients diagnosed with premature ovarian failure or ovarian insufficiency
  • Suboptimal response to conventional treatments like hormone replacement therapy, testosterone therapy, or assisted reproductive technologies
  • General good health without significant contraindications to stem cell or exosome therapy
  • Willing and able to provide informed consent and comply with the study protocol
  • Patients seeking further treatment for gonadal failure after evaluation
Not Eligible

You will not qualify if you...

  • Severe comorbid conditions such as advanced cardiovascular disease, renal failure, or uncontrolled diabetes
  • Active cancer or history of cancer within the past 5 years
  • Active infections or systemic inflammatory diseases
  • History of testicular or ovarian surgery or trauma interfering with study outcomes
  • Use of anticoagulants or medications contraindicating stem cell or exosome therapy
  • Participation in another investigational treatment study within the past 6 months
  • Immune deficiencies or allergies related to the study treatment
  • Severe neurological disorders or cognitive impairment affecting consent or compliance
  • Women diagnosed with psychogenic ovarian dysfunction or infertility
  • Any condition that poses undue risk or interferes with the study as judged by the investigator
  • History of ovarian surgery or trauma affecting study outcomes
  • Other contraindications to stem cell or exosome therapy as determined by the study team

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 1 day

Participants receive a single intra-gonadal injection of adipose-derived stem cells or stem cell-derived exosomes into the ovaries or testes under anesthesia.

1 treatment visit (in-person)

Follow-Up Monitoring

Duration - 12 months

Participants are monitored for safety and efficacy outcomes including hormonal changes, gonadal tissue regeneration, reproductive function, and adverse events.

Visits at 3, 6, 9, and 12 months post-treatment (in-person)

Trial Site Locations

Total: 1 location

1

First IVF and Day Surgery Center

Dubai, Dubai, United Arab Emirates

Actively Recruiting

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Research Team

R

Ranjith Ramasamy, MD

S

Sheila May, RN

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

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Published Research Related To This Trial

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.

Simin Zafardoust, Somaieh Kazemnejad, Maryam Darzi...

https://pubmed.ncbi.nlm.nih.gov/32198596