Premature Ovarian InsufficiencyPhase 2NCT07916740
Autologous Hair Follicle-Derived Secretome and Platelet-Rich Plasma for Premature Ovarian Insufficiency
A Phase 2 study testing Autologous Hair Follicle-Derived Secretome Combined With Platelet-Rich Plasma in people with Premature Ovarian Insufficiency and POI, run by Trio Fertility at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 25 to 40 years, women only
- Conditions the study is for
- Premature Ovarian Insufficiency, POI, Primary Ovarian Insufficiency (Poi)
- What is being tested?
- Autologous Hair Follicle-Derived Secretome Combined With Platelet-Rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 11 Sep 2025to 1 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Trio Fertility
Toronto, Ontario, M5G 2K4
Yasaman Sadeghi, 4165060804 ext. 2268, yasamans@triofertility.com
Robert Casper, M.D.
About this study
Official title: 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).
Read more
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.
Read the 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.
- Conditions
- Premature Ovarian Insufficiency, POI, Primary Ovarian Insufficiency (Poi), Premature Ovarian Failure (POF)
- Being tested
- Autologous Hair Follicle-Derived Secretome Combined With Platelet-Rich Plasma
- 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
- Medical subject headings
- Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Hair Follicle-Derived Secretome Combined With Platelet-Rich PlasmaBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Hair Follicle Secretome and PRP | Experimental | 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. Receives: Biological: Autologous Hair Follicle-Derived Secretome Combined With Platelet-Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum Follicle-Stimulating Hormone Levels
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.
Measured: From pretreatment baseline through 3 months after the last injection
Change in Serum Anti-Müllerian Hormone Levels
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.
Measured: From pretreatment baseline through 3 months after the last injection
Change in Antral Follicle Count
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.
Measured: From pretreatment baseline through 3 months after the last injection
Secondary outcomes (2)
Occurrence of Spontaneous Pregnancy
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.
Measured: From the initial injection through a year of follow-up
Occurrence of Pregnancy Following In Vitro Fertilization
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.
Measured: From the initial injection through a year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start11 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ovarian InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Trio Fertility
- Sponsor type
- University, hospital or other
- Collaborators
- Acorn Biolabs Inc.
- Responsible party
- Principal investigator, Dr. Robert F. Casper, Trio Fertility
- Investigators
- Robert Casper, M.D., Principal investigator, Trio Fertility
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916740
- Sponsor's protocol ID
- PRP/aHFS
- Status last verified
- Oct 2026
- First submitted
- 29 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Secretome From Autologous Hair Follicle-derived Mesenchymal Stem Cells Improve Ovarian Reserve in Women With Premature Ovarian Insufficiency?
- ClinicalTrials.gov ID
- NCT07916740
- Acronym / sponsor ID
- PRP/aHFS
- Conditions
- Premature Ovarian Insufficiency, POI, Primary Ovarian Insufficiency (Poi), Premature Ovarian Failure (POF)
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Trio FertilityUniversity, hospital or other
- Collaborators
- Acorn Biolabs Inc.
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Hair Follicle Secretome and PRP | Experimental | Biological: Autologous Hair Follicle-Derived Secretome Combined With Platelet-Rich PlasmaParticipants 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. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Hair Follicle-Derived Secretome Combined With Platelet-Rich PlasmaAutologous 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. | Biological | Autologous Hair Follicle Secretome and PRP |
Primary outcome
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.
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.
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.
2 secondary outcomes
Occurrence of Spontaneous Pregnancy
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Casper, M.D. principal investigator
Trio Fertility
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous Hair Follicle-Derived Secretome Combined With Platelet-Rich Plasma in people with Premature Ovarian Insufficiency and POI, run by Trio Fertility at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasaman Sadeghi, M.Sc. (4165060804 ext. 2268, yasamans@triofertility.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Follicle-Stimulating Hormone Levels (time frame: From pretreatment baseline through 3 months after the last injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.