Ovary; AnomalyPhase 2/3PRPNCT03937661
Autologous Platelet-Rich Plasma Intra-ovarian Infusion in Poor Responders
A Phase 2/3 study testing PRP in people with Ovary; Anomaly and Infertility, Female, run by Genesis Athens Clinic at 1 site in Greece.
Trial summary
Autologous PRP intra ovarian infusion may improve ovarian response, patients' hormonal profile as well as fresh embryo transfer (ET)-ICSI cycles' outcome in patients presenting with Poor Ovarian Response (POR). Read more about this study
- Who is it for?
- Ages 35 to 47 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovary; Anomaly, Infertility, Female
- What is being tested?
- PRP
- 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
- 6 May 2019to 30 Aug 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 35 to 47 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Poor Ovarian Response according to Bologna Criteria (fulfilling 2 out of 3 of the following)
- Age ≥ 40 years
- AMH < 1.1 ng/ml OR AFC < 7
- ≤ 3 oocytes with a conventional stimulation protocol)
- 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
- Cycle irregularities
- Amenorrhea
- Endometriosis
- Adenomyosis
- Fibroids and adhesions
Show all 15Show fewer
- Infections in reproductive system
- 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.
Greece1 site, 1 recruiting
- Recruiting
Genesis AC
Athens, 15232
Agni Pantou, MD, PhD Candidate, agni.pantou@genesisathens.gr
Agni Pantou, MD
About this study
Official title: Investigating Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Poor Responders
Autologous PRP intra ovarian infusion may improve ovarian response, patients' hormonal profile as well as fresh embryo transfer (ET)-ICSI cycles' outcome in patients presenting with Poor Ovarian Response (POR).
Read the detailed description
This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on improving ovarian tissue functionality and fresh ET-ICSI cycles' performance in regard to patients presenting with POR. 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 improving ovarian tissue functionality in POR patients.
- Conditions
- Ovary; Anomaly, Infertility, Female
- Being tested
- PRP, Placebo
- Medical subject headings
- Congenital Abnormalities, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPBiological
Autologous PRP intra ovarian infusion
PlaceboBiological
Autologous PFP intra ovarian infusion
| Study group | Role | What they receive |
|---|---|---|
| Group of participants receiving PRP treatment | Experimental | Women presenting with POR, treated with autologous PRP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period. Receives: Biological: PRP |
| Control Group: participants receiving Platelet Free Plasma | Placebo comparator | Women presenting with POR, treated with autologous PFP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved
Number of oocytes retrieved following COS in the first fresh ICSI-ET cycle following intervation performed on the third month of the follow-up period
Measured: 34-36 hours following hCG administration
AMH levels
Serum AMH levels evaluated monthly for three consecutive months
Measured: Follow-up period of three months entailing monthly evaluation
Secondary outcomes (2)
Clinical pregnancy rate
Clinical pregnancy rate, following the first fresh ET-ICSI cycle performed on the third month of the follow-up period
Measured: 6-7 weeks following last menstruation
Antral Follicle Count
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 posted6 May 2019
- Study start6 May 2019
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary; AnomalyStudies 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
- NCT03937661
- Sponsor's protocol ID
- PRP - poor responders
- Acronym
- PRP
- Status last verified
- Jul 2026
- First submitted
- 23 Apr 2019
- 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 Improvement of Ovarian Function Following Autologous PRP Intra-ovarian Infusion in Poor Responders
- ClinicalTrials.gov ID
- NCT03937661
- Acronym / sponsor ID
- PRP / PRP - poor responders
- Conditions
- Ovary; Anomaly, Infertility, Female
- 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
- 6 May 2019 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 6 May 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 improve ovarian response, patients' hormonal profile as well as fresh embryo transfer (ET)-ICSI cycles' outcome in patients presenting with Poor Ovarian Response (POR).
Detailed description
This triple-blind Randomized Controlled Trial (RCT) aims to investigate the effectiveness of autologous PRP intra ovarian infusion on improving ovarian tissue functionality and fresh ET-ICSI cycles' performance in regard to patients presenting with POR. 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 improving ovarian tissue functionality in POR 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 |
|---|---|---|
| Group of participants receiving PRP treatment | Experimental | Biological: PRPWomen presenting with POR, treated with autologous PRP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period. |
| Control Group: participants receiving Platelet Free Plasma | Placebo comparator | Biological: PlaceboWomen presenting with POR, treated with autologous PFP intra ovarian infusion and undergoing a subsequent fresh ET-ICSI cycle on the third month of the follow-up period |
Who may qualify
- Ages
- 35 to 47 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Poor Ovarian Response according to Bologna Criteria (fulfilling 2 out of 3 of the following)
- Age ≥ 40 years
- AMH < 1.1 ng/ml OR AFC < 7
- ≤ 3 oocytes with a conventional stimulation protocol)
- Discontinuation of any complementary/adjuvant treatment including hormone replacement, acupuncture, and botanotherapy, for at least three months prior to recruitment.
Key exclusion criteria (15 listed)
- Any pathological disorder related to reproductive system anatomy
- Cycle irregularities
- Amenorrhea
- Endometriosis
- Adenomyosis
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 |
|---|---|---|
| PRPAutologous PRP intra ovarian infusion | Biological | Group of participants receiving PRP treatment |
| PlaceboAutologous PFP intra ovarian infusion | Biological | Control Group: participants receiving Platelet Free Plasma |
Primary outcome
Number of oocytes retrieved
Time frame: 34-36 hours following hCG administration
Number of oocytes retrieved following COS in the first fresh ICSI-ET cycle following intervation performed on the third month of the follow-up period
AMH levels
Time frame: Follow-up period of three months entailing monthly evaluation
Serum AMH levels evaluated monthly for three consecutive months
2 secondary outcomes
Clinical pregnancy rate
Time frame: 6-7 weeks following last menstruation
Antral Follicle Count
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.
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 PRP in people with Ovary; Anomaly and Infertility, Female, 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 6 inclusion and 15 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?
Number of oocytes retrieved (time frame: 34-36 hours following hCG administration). 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.