Diminished Ovarian ReservePRP4POANCT04278313
Ovarian Function Following Intraovarian Injection of PRP
A study testing PRP - Platelet Rich Plasma and PPP - Platelet Poor Plasma in people with Diminished Ovarian Reserve and Diminished Ovarian Reserve Due to Advanced Maternal Age, run by Center for Human Reproduction at 1 site in United States.
Trial summary
Consenting women with evidence of poor ovarian reserve will be randomly assigned to treatment with either Platelet Rich Plasma (PRP) or Platelet Poor Plasma (PPP). Read more about this study
- Who is it for?
- Ages 21 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diminished Ovarian Reserve, Diminished Ovarian Reserve Due to Advanced Maternal Age
- What is being tested?
- PRP - Platelet Rich Plasma and PPP - Platelet Poor Plasma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2020to 31 Dec 2026
- Phase
- Interventional
- 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 21 to 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- fewer than 6 oocytes in response to past ovulation induction
- desire to establish a pregnancy using IVF
- Age 44 years and under.
- FSH > 12
- AMH < 1.0
- No Aspirin or Motrin for one week before treatment
Who cannot join
- Age > 45 years
- Marked thrombocytopenia
- Blood diseases
- Hypofibrinogenemia
- Hemodynamic instability
- Anticoagulant or antiaggregant treatment
Show all 10Show fewer
- Oncological diseases (specially, skeletal system and blood)
- Sepsis
- Acute and chronic infectious diseases
- Autoimmune diseases, for example, lupus erythematosus, 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: Randomized Controlled Trial of Ovarian Function Following Intraovarian Injection of Platelet Rich Plasma for Women With Ovarian Aging
Consenting women with evidence of poor ovarian reserve will be randomly assigned to treatment with either Platelet Rich Plasma (PRP) or Platelet Poor Plasma (PPP).
Read the detailed description
As women age oocytes are gradually depleted with a consequent progressive loss of ovarian function and fertility. When a woman's follicle cohort falls below a critical level, she enters a transitional time of diminished ovarian reserve known as ovarian aging. Recently the use of autologous platelet-rich plasma (A-PRP) has been proposed as an additional strategy for improving ovarian function. A-PRP is prepared from autologous blood using an FDA approved device. The rationale for the use of PRP is that it contains growth factors which stimulate cellular anabolism, inflammatory modulators that create an anti-inflammatory effect and fibrinogen which acts as a scaffold for regenerating tissue. The investigators hypothesize that the growth factors present in PRP may have a beneficial effect promoting growth and recruitment of antral follicles. The investigators will recruit a prospective cohort of 90 patients with evidence of Premature Ovarian Aging/DOR. Women invited to participate in this RCT will have FSH above 12 and AMH below 1.0 ng/mL respectively and will have had fewer than 6 oocytes retrieved in a previous ovulation attempt. Consenting participants in this trial will be randomized in a doubly blind fashion to two groups. One will receive Platelet Rich Plasma (PRP) and the other will receive Platelet Poor Plasma (PPP). Women assigned to PPP will be offerred PRP in a future cycle if they so desire.
- Being tested
- PRP - Platelet Rich Plasma, PPP - Platelet Poor Plasma
- Keywords
- Infertility - Ovarian dysfunuction, Diminished Ovarian Reserve, Premature Ovarian Aging (POA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP - Platelet Rich PlasmaProcedure or surgery
Using a sterile vacutainer technique two 8 ml samples of whole blood is drawn into two Regen Lab A-PRP vacutainers with gel separator and citrate. Invert the tube to mix with citrate. The whole blood undergoes two centrifugations, once for 3 minutes and again for 5 minutes. Using a 20-gauge 6-inch spinal needle 2 ml of Platelet POOR Plasma will be drawn off the supernatant from each tube to leave 2.5 ml of Platelet Rich Plasma in the tube. The tube is inverted several times to suspend the platelet pellet. The prepared plasma labeled with the participants name and randomization code will be transported to the procedure room.
PPP - Platelet Poor PlasmaProcedure or surgery
Using a sterile vacutainer technique two 8 ml samples of whole blood is drawn into two Regen Lab A-PRP vacutainers with gel separator and citrate. Invert the tube to mix with citrate. The whole blood undergoes two centrifugations, once for 3 minutes and again for 5 minutes. Using a 20-gauge 6-inch spinal needle 2 ml of Platelet POOR Plasma will be drawn off the supernatant from each tube. The prepared plasma will be transported to the procedure room. The prepared plasma labeled with the participants name and randomization code will be transported to the procedure room.
| Study group | Role | What they receive |
|---|---|---|
| PRP group | Experimental | Platelet RICH Plasma prepared using RegenLab FDA approved device. Receives: Procedure: PRP - Platelet Rich Plasma |
| PPP group | Placebo comparator | Platelet POOR Plasma prepared using RegenLab FDA approved device. Receives: Procedure: PPP - Platelet Poor Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo Transfer
Number of participants with at least one day-3 embryo 8-cell with less than 5% fragmentation in an IVF cycle
Measured: 6 weeks
Secondary outcomes (3)
Embryos Produced
Mean number of day-3 embryo 8-cell with less than 5% fragmentation produced
Measured: 6 weeks
AMH
Serum concentration of Anti Mullerian Hormone
Measured: 4 weeks
Antral Follicle Count
Number of Antral Follicles determined by pelvic sonogram on day 2 or 3 of menses
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start24 Feb 2020
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Factorial
- Model description
- Participants will be randomly assigned to treatment with either Platelet Rich Plasma (PRP) or Platelet Poor Plasma (PPP)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center for Human Reproduction
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David H Barad, MD, Principal investigator, Center for Human Reproduction
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278313
- Sponsor's protocol ID
- 02102020-0
- Acronym
- PRP4POA
- Status last verified
- Jan 2026
- First submitted
- 18 Feb 2020
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Ovarian Function Following Intraovarian Injection of Platelet Rich Plasma for Women With Ovarian Aging
- ClinicalTrials.gov ID
- NCT04278313
- Acronym / sponsor ID
- PRP4POA / 02102020-0
- Keywords
- Infertility - Ovarian dysfunuction, Diminished Ovarian Reserve, Premature Ovarian Aging (POA)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Center for Human ReproductionUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 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.
Consenting women with evidence of poor ovarian reserve will be randomly assigned to treatment with either Platelet Rich Plasma (PRP) or Platelet Poor Plasma (PPP).
Detailed description
As women age oocytes are gradually depleted with a consequent progressive loss of ovarian function and fertility. When a woman's follicle cohort falls below a critical level, she enters a transitional time of diminished ovarian reserve known as ovarian aging. Recently the use of autologous platelet-rich plasma (A-PRP) has been proposed as an additional strategy for improving ovarian function. A-PRP is prepared from autologous blood using an FDA approved device. The rationale for the use of PRP is that it contains growth factors which stimulate cellular anabolism, inflammatory modulators that create an anti-inflammatory effect and fibrinogen which acts as a scaffold for regenerating tissue. The investigators hypothesize that the growth factors present in PRP may have a beneficial effect promoting growth and recruitment of antral follicles. The investigators will recruit a prospective cohort of 90 patients with evidence of Premature Ovarian Aging/DOR. Women invited to participate in this RCT will have FSH above 12 and AMH below 1.0 ng/mL respectively and will have had fewer than 6 oocytes retrieved in a previous ovulation attempt. Consenting participants in this trial will be randomized in a doubly blind fashion to two groups. One will receive Platelet Rich Plasma (PRP) and the other will receive Platelet Poor Plasma (PPP). Women assigned to PPP will be offerred PRP in a future cycle if they so desire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to treatment with either Platelet Rich Plasma (PRP) or Platelet Poor Plasma (PPP)
| Arm | Type | Receives |
|---|---|---|
| PRP group | Experimental | Procedure: PRP - Platelet Rich PlasmaPlatelet RICH Plasma prepared using RegenLab FDA approved device. |
| PPP group | Placebo comparator | Procedure: PPP - Platelet Poor PlasmaPlatelet POOR Plasma prepared using RegenLab FDA approved device. |
Who may qualify
- Ages
- 21 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- fewer than 6 oocytes in response to past ovulation induction
- desire to establish a pregnancy using IVF
- Age 44 years and under.
- FSH > 12
- AMH < 1.0
Key exclusion criteria (10 listed)
- Age > 45 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 |
|---|---|---|
| PRP - Platelet Rich PlasmaUsing a sterile vacutainer technique two 8 ml samples of whole blood is drawn into two Regen Lab A-PRP vacutainers with gel separator and citrate. Invert the tube to mix with citrate. The whole blood undergoes two centrifugations, once for 3 minutes and again for 5 minutes. Using a 20-gauge 6-inch spinal needle 2 ml of Platelet POOR Plasma will be drawn off the supernatant from each tube to leave 2.5 ml of Platelet Rich Plasma in the tube. The tube is inverted several times to suspend the platelet pellet. The prepared plasma labeled with the participants name and randomization code will be transported to the procedure room. | Procedure or surgery | PRP group |
| PPP - Platelet Poor PlasmaUsing a sterile vacutainer technique two 8 ml samples of whole blood is drawn into two Regen Lab A-PRP vacutainers with gel separator and citrate. Invert the tube to mix with citrate. The whole blood undergoes two centrifugations, once for 3 minutes and again for 5 minutes. Using a 20-gauge 6-inch spinal needle 2 ml of Platelet POOR Plasma will be drawn off the supernatant from each tube. The prepared plasma will be transported to the procedure room. The prepared plasma labeled with the participants name and randomization code will be transported to the procedure room. | Procedure or surgery | PPP group |
Primary outcome
Embryo Transfer
Time frame: 6 weeks
Number of participants with at least one day-3 embryo 8-cell with less than 5% fragmentation in an IVF cycle
3 secondary outcomes
Embryos Produced
Time frame: 6 weeks
AMH
Time frame: 4 weeks
Antral Follicle Count
Time frame: 4 weeks
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 16 Jan 2026.
- Individual participant dataSharing planned: No. No plan to share IPD
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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.
David H Barad, MD principal investigator
Center for Human Reproduction
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP - Platelet Rich Plasma and PPP - Platelet Poor Plasma in people with Diminished Ovarian Reserve and Diminished Ovarian Reserve Due to Advanced Maternal Age, 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 6 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 16 Jan 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 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. 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.
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?
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?
Embryo Transfer (time frame: 6 weeks). 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 16 Jan 2026.