Recruiting
Phase 2

Stem Cell Secretome & PRP

Sponsor:

Trio Fertility

Code:

NCT07916740

Conditions

Premature Ovarian Insufficiency

POI

Primary Ovarian Insufficiency (Poi)

Premature Ovarian Failure (POF)

Eligibility Criteria

Sex: Female

Age: 25 - 40

Healthy Volunteers: Not accepted

Interventions

Autologous Hair Follicle-Derived Secretome Combined With Platelet-Rich Plasma

Study Details

Brief summary:

This single-arm, open-label pilot study aims to evaluate changes in ovarian function following administration of autologous hair follicle-derived mesenchymal stem cell secretome combined with autologous platelet-rich plasma (PRP) in women with premature ovarian insufficiency (POI).

The study plans to enroll 15 women aged 25-40 years with evidence of diminished ovarian activity, including elevated follicle-stimulating hormone (FSH), low anti-Müllerian hormone (AMH), and reduced antral follicle count (AFC).

The intervention is administered under transvaginal ultrasound guidance into the pelvic cul-de-sac, without direct ovarian injection. Participants undergo serial hormonal and ultrasound assessments to evaluate changes in FSH, AMH, and AFC. Secondary assessments include menstrual function, ovulation, and pregnancy outcomes.

The study is exploratory and is intended to generate preliminary data on ovarian response, feasibility, and safety to inform future controlled investigations.

Conditions

Premature Ovarian Insufficiency

POI

Primary Ovarian Insufficiency (Poi)

Premature Ovarian Failure (POF)

Study ID

NCT07916740

Start date

Sep 11, 2025

Status verified date

Oct, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 25 - 40

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Autologous Hair Follicle Secretome and PRP

Participants with premature ovarian insufficiency will receive autologous hair follicle-derived mesenchymal stem cell secretome combined with autologous platelet-rich plasma (PRP). The combined preparation will be administered into the pelvic cul-de-sac through transvaginal ultrasound-guided injection, without direct ovarian injection. Participants will undergo follow-up hormonal assessments and transvaginal ultrasound examinations to evaluate changes in ovarian function. According to the original protocol, an additional injection may be offered to participants who do not demonstrate an adequate response after approximately three months.

Interventions

Autologous Hair Follicle-Derived Secretome Combined With Platelet-Rich Plasma

Autologous hair follicle-derived mesenchymal stem cell secretome (aHFS) is prepared from hair follicles collected from each participant. On the day of treatment, approximately 20 mL of peripheral blood is collected to prepare autologous platelet-rich plasma (PRP). The PRP is used to reconstitute the participant's aHFS preparation.

The combined aHFS and PRP preparation is administered through a transvaginal ultrasound-guided injection into the pelvic cul-de-sac (pouch of Douglas), without direct injection into the ovaries.

Participants undergo serial hormonal and ultrasound assessments following treatment. According to the original protocol, a second injection may be offered to participants without an adequate ovarian response after approximately three months.

Primary outcome measure

  • Change in Serum Follicle-Stimulating Hormone Levels [ Time Frame: From pretreatment baseline through 3 months after the last injection ]
  • Change in Serum Anti-Müllerian Hormone Levels [ Time Frame: From pretreatment baseline through 3 months after the last injection ]
  • Change in Antral Follicle Count [ Time Frame: From pretreatment baseline through 3 months after the last injection ]

Central Contacts and Locations

Central contacts

Yasaman Sadeghi, M.Sc.

4165060804yasamans@triofertility.com

Locations

Trio Fertility

Recruiting

Toronto, Ontario, Canada, M5G 2K4

Contacts

Yasaman Sadeghi

4165060804yasamans@triofertility.com

Principal Investigator:

Robert Casper, M.D.

More Information

Sponsor

Trio Fertility

Last update posted

Nov 4, 2026

Last verified

Oct, 2026

Keywords

  • Premature Ovarian Insufficiency
  • Ovarian Reserve
  • Hair Follicle-Derived Mesenchymal Stem Cell Secretome
  • Platelet-Rich Plasma
  • Ovarian Rejuvenation
  • Antral Follicle Count
  • Anti-Müllerian Hormone
  • Follicle-Stimulating Hormone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by Trio Fertility on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.