Autologous Hair Follicle-Derived Secretome and Platelet-Rich Plasma for Premature Ovarian Insufficiency
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 2
Kontakty a umístění
Studijní kontakt
- Jméno: Yasaman Sadeghi, M.Sc.
- Telefonní číslo: 2268 4165060804
- E-mail: yasamans@triofertility.com
Studijní místa
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Ontario
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Toronto, Ontario, Kanada, M5G 2K4
- Nábor
- Trio Fertility
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Kontakt:
- Yasaman Sadeghi
- Telefonní číslo: 2268 4165060804
- E-mail: yasamans@triofertility.com
-
Vrchní vyšetřovatel:
- Robert Casper, M.D.
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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. |
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Serum Follicle-Stimulating Hormone Levels
Časové okno: From pretreatment baseline through 3 months after the last injection
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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
Časové okno: 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
|
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Change in Antral Follicle Count
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Occurrence of Spontaneous Pregnancy
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Robert Casper, M.D., Trio Fertility
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- PRP/aHFS
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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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