Autologous Hair Follicle-Derived Secretome and Platelet-Rich Plasma for Premature Ovarian Insufficiency

October 29, 2026 updated by: Dr. Robert F. Casper, Trio Fertility

Does the Secretome From Autologous Hair Follicle-derived Mesenchymal Stem Cells Improve Ovarian Reserve in Women With Premature Ovarian Insufficiency?

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Premature ovarian insufficiency (POI) is a condition in which ovarian function declines before the age of 40. Women with POI may experience irregular or absent menstrual periods, reduced estrogen production, and difficulty becoming pregnant. Current treatment options are limited, particularly for women who wish to conceive using their own eggs. New approaches that may support residual ovarian activity are therefore of considerable interest.

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

The secretome is a preparation containing biologically active substances released by cultured cells, including growth factors and signaling molecules. These substances may influence cellular communication and tissue repair. PRP is prepared from the participant's own blood and contains concentrated platelets that release growth factors. Combining these two preparations is being investigated as a potential approach to supporting ovarian function. However, its effectiveness for POI has not been established.

The study plans to enroll 15 women aged 25-40 years with POI, characterized by elevated follicle-stimulating hormone (FSH), low anti-Müllerian hormone (AMH), and reduced antral follicle count (AFC).

Hair follicles and blood samples are collected from each participant to prepare the autologous secretome and PRP. The combined preparation is administered into the pelvic cul-de-sac under transvaginal ultrasound guidance, without direct injection into the ovaries. Participants undergo follow-up assessments, including blood tests and transvaginal ultrasound examinations, to monitor changes in ovarian function.

The primary outcomes are changes in serum FSH, AMH, and AFC compared with pretreatment measurements. Secondary outcomes include changes in menstrual function, evidence of ovulation, and pregnancy outcomes, including spontaneous pregnancy and pregnancy following fertility treatment.

The study is exploratory and does not include a placebo or untreated comparison group. Its findings will provide preliminary information about changes in ovarian function following treatment and help guide the design of future studies involving larger numbers of participants and appropriate control groups.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2K4
        • Recruiting
        • Trio Fertility
        • Contact:
        • Principal Investigator:
          • Robert Casper, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Biological: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Serum Follicle-Stimulating Hormone Levels
Time Frame: From pretreatment baseline through 3 months after the last injection

Change in serum follicle-stimulating hormone (FSH) concentration, measured in international units per liter (IU/L), from pretreatment baseline to follow-up. FSH is a hormone involved in regulating ovarian function and is typically elevated in women with premature ovarian insufficiency. Blood samples will be collected to assess changes in FSH levels following treatment. A decrease in FSH may indicate a change in ovarian hormonal activity.
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 serum anti-Müllerian hormone (AMH) concentration from pretreatment baseline to follow-up. AMH is produced by cells surrounding developing ovarian follicles and is commonly used as a marker of ovarian reserve. Blood samples will be collected to evaluate changes in AMH following treatment. An increase in AMH may suggest a change in ovarian follicular activity.
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

Change in antral follicle count (AFC), measured using transvaginal ultrasound, from pretreatment baseline to follow-up. Antral follicles are small, fluid-filled structures within the ovaries that contain developing eggs. The number of visible antral follicles will be recorded at each assessment. An increase in AFC may indicate an improvement in measurable ovarian follicular activity.
From pretreatment baseline through 3 months after the last injection

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Occurrence of Spontaneous Pregnancy
Time Frame: From the initial injection through a year of follow-up

Number and proportion of participants who achieve a spontaneous pregnancy without assisted reproductive treatment following administration of autologous hair follicle-derived secretome combined with platelet-rich plasma. Pregnancy will be assessed using clinical follow-up and available pregnancy testing results.
From the initial injection through a year of follow-up
Occurrence of Pregnancy Following In Vitro Fertilization
Time Frame: From the initial injection through a year of follow-up

Number and proportion of participants who achieve pregnancy following in vitro fertilization (IVF) after treatment with autologous hair follicle-derived secretome combined with platelet-rich plasma. Participants demonstrating sufficient ovarian response may be considered for IVF according to the study protocol. Pregnancy outcomes will be assessed through available clinical follow-up records.
From the initial injection through a year of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Trio Fertility

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Acorn Biolabs Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Casper, M.D., Trio Fertility

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRP/aHFS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) will not be made publicly available or shared with external researchers due to the small sample size and the sensitive nature of the reproductive health information collected. The study involves a limited number of participants with premature ovarian insufficiency, which may increase the risk of participant re-identification even after removal of direct identifiers. Participant confidentiality will be maintained in accordance with the approved research protocol and institutional review board requirements. Aggregated, de-identified study results may be reported in scientific publications and conference presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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