Autologous Hair Follicle Secretome + PRP for POI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a small, single-arm study to explore whether autologous hair follicle–derived mesenchymal stem cell secretome together with autologous PRP can modulate ovarian function in POI. Participants receive the combination therapy via transvaginal injection under ultrasound guidance and are followed with serial hormone tests and ultrasound assessments. Outcomes include changes in FSH, AMH, AFC, as well as menstrual function, ovulation, and pregnancy status. The study aims to generate preliminary data on feasibility, safety, and potential ovarian response to inform future controlled trials.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Women aged 25-40 years.
* Diagnosis of premature ovarian insufficiency (POI), defined by an antral follicle count (AFC) of fewer than 5.
* Serum anti-Müllerian hormone (AMH) level below 3 pmol/L.
* Serum follicle-stimulating hormone (FSH) level above 30 IU/L on two occasions at least one month apart.
* Not receiving other medical or fertility treatments, except natural estrogen for the management of menopausal symptoms.
* Able and willing to provide informed consent.

Exclusion Criteria:

* Women older than 40 years.
* History of autoimmune disorders.
* History of hematopoietic cell malignancies.
* Medical conditions that would preclude infertility treatment or pregnancy, including HIV/AIDS, hepatitis B or C, or breast cancer.
* Body mass index (BMI) greater than 40 kg/m².

Where it's running

• Trio Fertility
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Robert Casper, M.D. — Trio Fertility
• Study coordinator: Yasaman Sadeghi, M.Sc.
• Email: yasamans@triofertility.com
• Phone: 4165060804

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.