Diminished Ovarian ReservePRP4AGENCT04275700
Study of PRP in Women With Evidence of Diminished Ovarian Reserve
A study testing A-PRP in people with Diminished Ovarian Reserve and Ovarian Failure, run by Center for Human Reproduction at 1 site in United States.
Trial summary
The hypothesis of the study is that ovaries of women with a history of poor response to ovulation induction may benefit from exposure to growth factors known to be present in Platelet Rich Plasma (PRP). Read more about this study
- Who is it for?
- Ages 21 to 52 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diminished Ovarian Reserve, Ovarian Failure
- What is being tested?
- A-PRP
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 52 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women with failure to respond well to ovulation induction by having fewer than 1 cleavage stage embryo in response to past ovulation induction who do not qualify for the PRP4POI study
- Age 54 years and under.
- FSH > 12
- AMH < 1.1
- -No Aspirin or Motrin for one week before treatment
Who cannot join
- Age > 54 years
- Marked thrombocytopenia
- Blood diseases
- Hypofibrinogenemia
- Hemodynamic instability
- Anticoagulant or antiaggregant treatment
Show all 16Show fewer
- Oncological diseases (specially, skeletal system and blood)
- Sepsis
- Acute and chronic infectious diseases
- Autoimmune diseases, for example, lupus erythematosus, etc.
- Relative contraindications for PRP
- Chronic liver diseases in the exacerbation phase
- Chronic intoxication against the background of long-term use of alcohol, addictive drugs, an administration of potent medications
- Use of steroidal anti-inflammatory drugs in less than 2 days before drawing the blood, an injection of corticosteroids in little less than 2 weeks before the procedure
- Pregnancy
- Inflammatory skin diseases, chronic dermatosis in the exacerbation phase, for example, psoriasis, atopic eczema, etc.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center For Human Reproduction
New York, New York, 10021
About this study
Official title: Study of Ovarian Function Following Intraovarian Injection of Platelet Rich Plasma (PRP) In Women With Evidence of Diminished Ovarian Function
The hypothesis of the study is that ovaries of women with a history of poor response to ovulation induction may benefit from exposure to growth factors known to be present in Platelet Rich Plasma (PRP). Since even ovaries from women with poor response still contain primordial follicles (which, however, no longer undergo recruitment), it is hoped that PRP injections into ovaries will activate follicular recruitment pathways and, subsequently, result in follicle growth. Should such growth be observed, follicles will be supported with routine daily gonadotropin stimulation until hCG trigger.
Read the detailed description
The hypothesis of the study is that ovaries of women with a history of poor response to ovulation induction may benefit from exposure to growth factors known to be present in PRP.
Autologous Platelet Rich Plasma (A-PRP) is plasma with a concentration of platelets above the blood baseline. A-PRP is developed from autologous blood. Within A-PRP, the concentration of platelets delivers an increased number of growth factors. In this study A-PRP will be prepared using Regen Lab PRP Kit which is approved by US-FDA for preparation of PRP.
PRP is becoming widely used in a variety of medical procedures seeking tissue remodeling and/or healing as an intervention. To date, applications in orthopedics, wound healing, dermatology and plastic surgery have gained general acceptance, primarily as the role of platelets and their activation in tissue repair and recovery has become better understood at a cellular and molecular level. This knowledge base provides a foundation for the present study because of the ready availability of FDA-approved kits for autologous PRP preparations and the recognition that the aging ovary acquires tissue pathologies in the form of wound healing and fibrosis as a result of repeat ovulations over the reproductive lifespan of women. Since PRP is an autologous blood product, and is widely used via injection into various organs and tissues, safety concerns are minimal.
This study will involve only adult women with a diagnosis of diminished ovarian reserve. All consenting participants will receive injections of autologous Platelet RIch Plasma (A-PRP) in both ovaries under ultrasound guidance performed after induction of IV sedation.
Assumption of this study is that in women with previous poor response to ovulation induction will show limited follicle growth. The study will try to estimate effect of PRP on this condition by comparing post-PRP response to the previous response. The investigators recognize that there will be a possibility of apparent response based on regression to the mean. The investigators expect that study of fifty patients should be enough to determine if there is a potential clinical effect and to allow estimation of that effect for power calculations for future studies.
- Conditions
- Diminished Ovarian Reserve, Ovarian Failure
- Being tested
- A-PRP
- Keywords
- Platelet Rich Plasma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A-PRPProcedure or surgery
Also called Autologous Platelet Rich Plasma
The cortex of each ovary will be injected with autologous platelet rich plasma. Up to seven different sites will be injected under ultrasound guidance. The patient will be under IV sedation.
| Study group | Role | What they receive |
|---|---|---|
| A-PRP | Experimental | The cortex of each ovary will be injected with autologous platelet rich plasma. Receives: Procedure: A-PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Emergence of new ovarian follicles with evidence of estradiol production
Emergence of new ovarian follicles greater than 4 mm in average diameter as measured using pelvic sonography with evidence of change estradiol serum estradiol levels as measured using a immuno assay.
Measured: Change from baseline to 12 weeks
Secondary outcomes (3)
Change in serum AMH
Increase in serum AMH from baseline level as measured using an immuno assay
Measured: Change from baseline to 12 weeks
Number of participants with retrieval of oocytes in an IVF cycle
Number of participants with retrieval of oocytes in an IVF cycle
Measured: 6 months
Number of participants that establish a Clinical Pregnancy
Number of participants that establish a Clinical Pregnancy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 Oct 2018
- Primary completion1 Jun 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diminished Ovarian ReserveStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each Ovary will be injected with A-PRP.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Human Reproduction
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norbert Gleicher, MD, Study chair, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275700
- Sponsor's protocol ID
- 09182018-01
- Acronym
- PRP4AGE
- Status last verified
- May 2025
- First submitted
- 22 Oct 2018
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual patient data.
Publications
Barad DH, Albertini DF, Molinari E, Gleicher N. Preliminary report of intraovarian injections of autologous platelet-rich plasma (PRP) in extremely poor prognosis patients with only oocyte donation as alternative: a prospective cohort study. Hum Reprod Open. 2022 Jun 28;2022(3):hoac027. doi: 10.1093/hropen/hoac027. eCollection 2022.
PubMed 35795849
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Ovarian Function Following Intraovarian Injection of Platelet Rich Plasma (PRP) In Women With Evidence of Diminished Ovarian Function
- ClinicalTrials.gov ID
- NCT04275700
- Acronym / sponsor ID
- PRP4AGE / 09182018-01
- Conditions
- Diminished Ovarian Reserve, Ovarian Failure
- Keywords
- Platelet Rich Plasma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Center for Human ReproductionUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 19 Feb 2020 (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.
The hypothesis of the study is that ovaries of women with a history of poor response to ovulation induction may benefit from exposure to growth factors known to be present in Platelet Rich Plasma (PRP). Since even ovaries from women with poor response still contain primordial follicles (which, however, no longer undergo recruitment), it is hoped that PRP injections into ovaries will activate follicular recruitment pathways and, subsequently, result in follicle growth. Should such growth be observed, follicles will be supported with routine daily gonadotropin stimulation until hCG trigger.
Detailed description
The hypothesis of the study is that ovaries of women with a history of poor response to ovulation induction may benefit from exposure to growth factors known to be present in PRP.
Autologous Platelet Rich Plasma (A-PRP) is plasma with a concentration of platelets above the blood baseline. A-PRP is developed from autologous blood. Within A-PRP, the concentration of platelets delivers an increased number of growth factors. In this study A-PRP will be prepared using Regen Lab PRP Kit which is approved by US-FDA for preparation of PRP.
PRP is becoming widely used in a variety of medical procedures seeking tissue remodeling and/or healing as an intervention. To date, applications in orthopedics, wound healing, dermatology and plastic surgery have gained general acceptance, primarily as the role of platelets and their activation in tissue repair and recovery has become better understood at a cellular and molecular level. This knowledge base provides a foundation for the present study because of the ready availability of FDA-approved kits for autologous PRP preparations and the recognition that the aging ovary acquires tissue pathologies in the form of wound healing and fibrosis as a result of repeat ovulations over the reproductive lifespan of women. Since PRP is an autologous blood product, and is widely used via injection into various organs and tissues, safety concerns are minimal.
This study will involve only adult women with a diagnosis of diminished ovarian reserve. All consenting participants will receive injections of autologous Platelet RIch Plasma (A-PRP) in both ovaries under ultrasound guidance performed after induction of IV sedation.
Assumption of this study is that in women with previous poor response to ovulation induction will show limited follicle growth. The study will try to estimate effect of PRP on this condition by comparing post-PRP response to the previous response. The investigators recognize that there will be a possibility of apparent response based on regression to the mean. The investigators expect that study of fifty patients should be enough to determine if there is a potential clinical effect and to allow estimation of that effect for power calculations for future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Each Ovary will be injected with A-PRP.
| Arm | Type | Receives |
|---|---|---|
| A-PRP | Experimental | Procedure: A-PRPThe cortex of each ovary will be injected with autologous platelet rich plasma. |
Who may qualify
- Ages
- 21 to 52 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women with failure to respond well to ovulation induction by having fewer than 1 cleavage stage embryo in response to past ovulation induction who do not qualify for the PRP4POI study
- Age 54 years and under.
- FSH > 12
- AMH < 1.1
- -No Aspirin or Motrin for one week before treatment
Key exclusion criteria (16 listed)
- Age > 54 years
- Marked thrombocytopenia
- Blood diseases
- Hypofibrinogenemia
- Hemodynamic instability
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 |
|---|---|---|
| A-PRPAlso: Autologous Platelet Rich PlasmaThe cortex of each ovary will be injected with autologous platelet rich plasma. Up to seven different sites will be injected under ultrasound guidance. The patient will be under IV sedation. | Procedure or surgery | A-PRP |
Primary outcome
Emergence of new ovarian follicles with evidence of estradiol production
Time frame: Change from baseline to 12 weeks
Emergence of new ovarian follicles greater than 4 mm in average diameter as measured using pelvic sonography with evidence of change estradiol serum estradiol levels as measured using a immuno assay.
3 secondary outcomes
Change in serum AMH
Time frame: Change from baseline to 12 weeks
Number of participants with retrieval of oocytes in an IVF cycle
Time frame: 6 months
Number of participants that establish a Clinical Pregnancy
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Background: PubMed 35795849Barad DH, Albertini DF, Molinari E, Gleicher N. Preliminary report of intraovarian injections of autologous platelet-rich plasma (PRP) in extremely poor prognosis patients with only oocyte donation as alternative: a prospective cohort study. Hum Reprod Open. 2022 Jun 28;2022(3):hoac027. doi: 10.1093/hropen/hoac027. eCollection 2022.
- Individual participant dataSharing planned: No. We do not plan to share individual patient data.
Related trials for Diminished Ovarian Reserve
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Study of G-CSF for DOR in Patients Undergoing IVF
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Guishen Yijing Granules for Diminished Ovarian Reserve With Kidney Deficiency Syndrome: A Randomized Controlled Trial
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hCG Priming in Women With Diminished Ovarian Reserve
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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. This study is not recruiting at the moment.
Norbert Gleicher, MD study chair
Medical Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A-PRP in people with Diminished Ovarian Reserve and Ovarian Failure, run by Center for Human Reproduction at 1 site in United States.
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 5 inclusion and 16 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: finished, as of the sponsor's last update on 7 May 2025. 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 United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emergence of new ovarian follicles with evidence of estradiol production (time frame: Change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04275700, which also lists 1 linked publication.
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 7 May 2025.