Menopause, PrematurePhase 2/3PRPNCT04031456
Autologous PRP Infusion May Restore Ovarian Function and May Promote Folliculogenesis in POI Patients
A Phase 2/3 study testing Autologous Platelet Rich Plasma in people with Menopause, Premature and Menopause Related Conditions, run by Genesis Athens Clinic at 1 site in Greece.
Trial summary
Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI. Read more about this study
- Who is it for?
- Ages 25 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menopause, Premature, Menopause Related Conditions, Menopausal Syndrome
- What is being tested?
- Autologous Platelet Rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 30 Jul 2019to 30 Jul 2028
- Phase
- Phase 2/3
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age < 40 years, presenting with amenorrhea or menstrual cycle irregularities for at least four months, and elevated FSH levels >25 IU/L recorded on two occasions >4 weeks apart
- Normal Karyotype: 46, XX
- Discontinuation of any complementary/adjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment.
- Willing to comply with study requirements
Who cannot join
- Any pathological disorder related to reproductive system anatomy
- AMH > 8 pmol/L
- Endometriosis
- Adenomyosis
- Fibroids and adhesions
- Infections in reproductive system
Show all 14Show fewer
- Current or previous diagnosis of cancer in reproductive system
- History of familiar cancer in reproductive system
- Severe male factor infertility
- Prior referral for PGT
- Ovarian inaccessibility
- Endocrinological disorders (Hypothalamus-Pituitary disorders, thyroid dysfunction, diabetes mellitus, metabolic syndrome)
- BMI>30 kg/m2 or BMI<18.5 kg/m2
- Systematic autoimmune disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Agni Pantou, MD, PhD Candidate contact
Greece1 site, 1 recruiting
- Recruiting
Genesis AC
Athens, 15232
Mara Simopoulou, PhD
Agni Pantou, MD
About this study
Official title: Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in POI Patients
Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.
Read the detailed description
This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on reactivating ovarian functionality and on promoting folliculogenesis in regard to patients presenting with POI. PRP is blood plasma prepared from fresh whole blood that has been enriched with platelets. It is collected from peripheral veins and contains several growth factors such as vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), platelet derived growth factor (PDGF), transforming growth factor (TGF) and other cytokines all of which stimulate tissue proliferation and growth. PRP has been employed in several medical conditions in Orthopedics, Dermatology, and Ophthalmology for wound healing. It's efficacy in ovarian rejuvenation and reactivation and endometrial regeneration has not been fully elucidated. This study aims to investigate the effect of autologous PRP intra ovarian infusion on restoring ovarian tissue functionality in POI patients.
- Conditions
- Menopause, Premature, Menopause Related Conditions, Menopausal Syndrome, Premature Ovarian Failure, Ovarian Failure, Premature
- Being tested
- Autologous Platelet Rich Plasma, Placebo-Platelet Free Plasma
- Medical subject headings
- Menopause, Premature, Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet Rich PlasmaBiological
Also called PRP, Platelet Rich Plasma
Autologous PRP intra ovarian infusion
Placebo-Platelet Free PlasmaBiological
Also called PFP
Autologous PFP intra ovarian infusion
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving PRP treatment | Experimental | Women presenting with POI, 25-39 years of age, treated with autologous PRP intra ovarian infusion Receives: Biological: Autologous Platelet Rich Plasma |
| Participants receiving Platelet Free Plasma (PFP) treatment | Placebo comparator | Women presenting with POI, 25-39 years of age, treated with autologous PFP intra ovarian infusion Receives: Biological: Placebo-Platelet Free Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Restoration of menstrual cycle
Regular menstrual cycle
Measured: Three months
Serum FSH levels
Serum FSH levels evaluated monthly for three consecutive months
Measured: Follow-up period of three months entailing monthly evaluation
Secondary outcomes (5)
Serum AMH levels
Serum ΑΜΗ levels evaluated monthly for three consecutive months
Measured: Follow-up period of three months entailing monthly evaluation
Serum LH levels
Serum LH levels evaluated monthly for three consecutive months
Measured: Follow-up period of three months entailing monthly evaluation
Serum Estradiol levels
Serum estradiol levels evaluated monthly for three consecutive months
Measured: Follow-up period of three months entailing monthly evaluation
Serum Progesteron levels
Serum progesterone levels evaluated monthly for three consecutive months
Measured: Follow-up period of three months entailing monthly evaluation
Antral Follicle Count (AFC)
AFC evaluated monthly, on day 2 of the menstrual cycle, for three consecutive months
Measured: Follow-up period of three months entailing monthly evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2019
- Study start30 Jul 2019
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menopause, PrematureStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genesis Athens Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04031456
- Sponsor's protocol ID
- PRP- POI
- Acronym
- PRP
- Status last verified
- Jul 2026
- First submitted
- 25 Oct 2017
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Reactivation of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in POI Patients
- ClinicalTrials.gov ID
- NCT04031456
- Acronym / sponsor ID
- PRP / PRP- POI
- Conditions
- Menopause, Premature, Menopause Related Conditions, Menopausal Syndrome, Premature Ovarian Failure, Ovarian Failure, Premature
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Genesis Athens ClinicUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 24 Jul 2019 (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.
Autologous PRP intra ovarian infusion may restore ovarian function, may promote folliculogenesis and may improve patients' hormonal profile in patients presenting with POI.
Detailed description
This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on reactivating ovarian functionality and on promoting folliculogenesis in regard to patients presenting with POI. PRP is blood plasma prepared from fresh whole blood that has been enriched with platelets. It is collected from peripheral veins and contains several growth factors such as vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), platelet derived growth factor (PDGF), transforming growth factor (TGF) and other cytokines all of which stimulate tissue proliferation and growth. PRP has been employed in several medical conditions in Orthopedics, Dermatology, and Ophthalmology for wound healing. It's efficacy in ovarian rejuvenation and reactivation and endometrial regeneration has not been fully elucidated. This study aims to investigate the effect of autologous PRP intra ovarian infusion on restoring ovarian tissue functionality in POI patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants receiving PRP treatment | Experimental | Biological: Autologous Platelet Rich PlasmaWomen presenting with POI, 25-39 years of age, treated with autologous PRP intra ovarian infusion |
| Participants receiving Platelet Free Plasma (PFP) treatment | Placebo comparator | Biological: Placebo-Platelet Free PlasmaWomen presenting with POI, 25-39 years of age, treated with autologous PFP intra ovarian infusion |
Who may qualify
- Ages
- 25 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age < 40 years, presenting with amenorrhea or menstrual cycle irregularities for at least four months, and elevated FSH levels >25 IU/L recorded on two occasions >4 weeks apart
- Normal Karyotype: 46, XX
- Discontinuation of any complementary/adjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment.
- Willing to comply with study requirements
Key exclusion criteria (14 listed)
- Any pathological disorder related to reproductive system anatomy
- AMH > 8 pmol/L
- Endometriosis
- Adenomyosis
- Fibroids and adhesions
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 Platelet Rich PlasmaAlso: PRP, Platelet Rich PlasmaAutologous PRP intra ovarian infusion | Biological | Participants receiving PRP treatment |
| Placebo-Platelet Free PlasmaAlso: PFPAutologous PFP intra ovarian infusion | Biological | Participants receiving Platelet Free Plasma (PFP) treatment |
Primary outcome
Restoration of menstrual cycle
Time frame: Three months
Regular menstrual cycle
Serum FSH levels
Time frame: Follow-up period of three months entailing monthly evaluation
Serum FSH levels evaluated monthly for three consecutive months
5 secondary outcomes
Serum AMH levels
Time frame: Follow-up period of three months entailing monthly evaluation
Serum LH levels
Time frame: Follow-up period of three months entailing monthly evaluation
Serum Estradiol levels
Time frame: Follow-up period of three months entailing monthly evaluation
Serum Progesteron levels
Time frame: Follow-up period of three months entailing monthly evaluation
Antral Follicle Count (AFC)
Time frame: Follow-up period of three months entailing monthly evaluation
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 8 Jul 2026.
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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.
Agni Pantou, MD, PhD Candidate contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Autologous Platelet Rich Plasma in people with Menopause, Premature and Menopause Related Conditions, run by Genesis Athens Clinic at 1 site in Greece.
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 4 inclusion and 14 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 8 Jul 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 Greece. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mara Simopoulou, PhD (+306979234100, marasimopoulou@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Restoration of menstrual cycle (time frame: Three months). The study lists 2 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 8 Jul 2026.