PRP for Diminished Ovarian Reserve

(PRP4AGE Trial)

Overseen By David H Barad, MD MS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Center for Human Reproduction

Must not be taking: Anticoagulants, Antiaggregants, Steroids, others

Disqualifiers: Blood diseases, Cancer, Sepsis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Platelet Rich Plasma (PRP), which contains growth factors, can assist women whose ovaries do not respond well to typical fertility treatments. Researchers aim to stimulate the growth of egg follicles by injecting PRP into the ovaries. Women who have faced challenges with fertility treatments and have developed fewer than one embryo are ideal candidates for this trial. Participants should avoid certain medications, such as Aspirin or Motrin, a week before treatment. As an unphased trial, this study provides a unique opportunity for women to explore innovative fertility treatment options.

Will I have to stop taking my current medications?

The trial requires that you stop taking Aspirin or Motrin for one week before treatment. If you are on anticoagulant or antiaggregant treatment, you may not be eligible to participate.

What prior data suggests that this treatment is safe?

Research has shown that using Platelet-Rich Plasma (PRP) to treat conditions like low ovarian reserve is generally safe. PRP, derived from the patient's own blood, helps minimize safety concerns. It is already used in various medical fields, including injections into different body parts.

Previous patients have demonstrated that PRP treatments are usually well-tolerated, with little evidence of serious side effects. Some studies have found that PRP can improve important fertility factors in women with low ovarian reserves, potentially enhancing ovary function without causing major issues.

Overall, PRP appears to be a low-risk option for those considering this type of treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for diminished ovarian reserve, such as hormone therapy or IVF, A-PRP (autologous platelet-rich plasma) uses the body's own platelets injected directly into the ovaries to potentially rejuvenate ovarian tissue. This approach is unique because it harnesses the natural growth factors found in a patient's blood to stimulate ovarian function. Researchers are excited about A-PRP because it offers a new mechanism of action that could enhance fertility without relying on synthetic hormones, possibly leading to fewer side effects and a more natural restoration of ovarian health.

What evidence suggests that A-PRP might be an effective treatment for diminished ovarian reserve?

Research has shown that injecting Platelet-Rich Plasma (PRP) into the ovaries can improve fertility in women with low ovarian reserve. In this trial, participants will receive A-PRP, with autologous platelet-rich plasma injected into the cortex of each ovary. One study found that PRP treatment improved fertility by enhancing key markers of ovarian health. Another study discovered that both single and double PRP injections enhanced ovarian reserve and embryo quality. Additionally, a review of multiple studies indicated that PRP injections into the ovaries can regenerate them and improve reproductive outcomes. Specifically, in a group of 510 women, PRP injections improved ovarian reserve and resulted in a pregnancy rate of 20.5%. These findings suggest that PRP could effectively boost fertility in women with low ovarian reserve. ^{1 3 6 7 8}

Who Is on the Research Team?

Norbert Gleicher, MD

Principal Investigator

Medical Director

Are You a Good Fit for This Trial?

This trial is for women under 55 with diminished ovarian reserve, evidenced by a poor response to ovulation induction and specific hormone levels (FSH > 12, AMH < 1.1). Participants should not have taken Aspirin or Motrin for a week before treatment. Women with blood diseases, autoimmune conditions like lupus, or those on certain medications are excluded.

Inclusion Criteria

I am 54 years old or younger.

I haven't taken Aspirin or Motrin in the last week.

I am 54 years old or younger.

Exclusion Criteria

I have a cancer affecting my bones or blood.

I have a very low platelet count.

I am older than 54 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of autologous Platelet Rich Plasma (A-PRP) in both ovaries under ultrasound guidance

12 weeks

Multiple visits for injections and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in serum AMH and emergence of new ovarian follicles

12 weeks

Long-term Follow-up

Participants are monitored for retrieval of oocytes and establishment of clinical pregnancy

12 months

What Are the Treatments Tested in This Trial?

Interventions

• A-PRP

Trial Overview

The study tests if injecting Platelet Rich Plasma (PRP) into the ovaries can stimulate follicle growth in women who've had inadequate responses to fertility treatments. Following PRP injections, routine fertility drugs will be used until hCG trigger.

How Is the Trial Designed?

Group I: A-PRP Experimental Treatment 1 Intervention

The cortex of each ovary will be injected with autologous platelet rich plasma.

Who Is Running the Clinical Trial?

Center for Human Reproduction

Lead Sponsor

Trials

14

Recruited

1,200+

Published Research Related to This Trial

In a study of 80 women aged 28-54 with extremely low functional ovarian reserve, intraovarian injection of platelet-rich plasma (PRP) did not show any clinically significant improvements in ovarian function over a 1-year follow-up period.

Despite the lack of overall efficacy, two patients achieved pregnancy after PRP treatment, suggesting that while sporadic pregnancies are possible in this population, the study does not confirm that PRP was the cause of these pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Barad, DH., Albertini, DF., Molinari, E., et al.[2022]

Intra-ovarian injection of platelet-rich plasma (PRP) significantly increased anti-Müllerian hormone (AMH) levels in 22 women with poor ovarian reserve, suggesting a potential improvement in fertility.

While AMH levels rose after PRP treatment, there were no significant changes in antral follicle counts (AFC), indicating that while PRP may enhance ovarian function, it does not necessarily increase the number of visible follicles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-ovarian infusion of autologous platelet-rich plasma in women with poor ovarian reserve: A before and after study. Hosseinisadat, R., Farsi Nejad, A., Mohammadi, F.[2022]

In a clinical trial involving 35 women with poor ovarian reserve, a single intraovarian injection of autologous platelet-rich plasma (PRP) significantly increased the number of oocytes and embryos produced, indicating its potential efficacy in improving ovarian response.

The treatment also led to elevated estradiol levels, suggesting that PRP may enhance ovarian function, although more research is needed to determine its impact on live birth rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraovarian Injection of Autologous Platelet-Rich Plasma Improves Therapeutic Approaches in The Patients with Poor Ovarian Response: A Before-After Study. Navali, N., Sadeghi, L., Farzadi, L., et al.[2022]

Platelet-rich plasma (PRP) therapy may improve ovarian function and increase pregnancy chances in women with very low ovarian reserve and premature ovarian insufficiency, based on a review of 25 studies and 2 abstracts.

Despite some skepticism about PRP's role in fertility treatments, its low-risk profile and potential benefits warrant further investigation through larger randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. Seckin, S., Ramadan, H., Mouanness, M., et al.[2023]

Intraovarian injection of platelet rich plasma (PRP) shows promise in improving ovarian reserve markers and increasing oocyte and embryo yields in patients with poor ovarian response (POR) and primary ovarian insufficiency (POI), as indicated by several case series and one prospective trial.

Patients who previously failed treatment have reported multiple live births after receiving PRP injections, suggesting that this novel treatment could enhance fertility outcomes for those with poor prognosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of intraovarian injection of autologous platelet rich plasma (PRP) in patients with poor ovarian response and premature ovarian insufficiency. Herlihy, NS., Seli, E.[2022]

In a pilot study involving 4 women with diminished ovarian reserve, the injection of autologous platelet-rich plasma (PRP) into the ovaries led to improved ovarian function, as indicated by increased serum AMH levels and decreased FSH levels, allowing for the retrieval of viable oocytes for IVF.

This is the first report of direct PRP injection into human ovaries for infertility treatment, showing promising results in enhancing ovarian reserve and function, although further research is needed to understand the specific components of PRP that contribute to these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First data on in vitro fertilization and blastocyst formation after intraovarian injection of calcium gluconate-activated autologous platelet rich plasma. Sills, ES., Rickers, NS., Li, X., et al.[2022]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11100055/

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PRP treatment resulted in a statistically significant improvement in the main fertility parameters of diminished ovarian reserve women.

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Comparative efficacy of single vs. double autologous ...

Our results demonstrated that both single and double PRP injections significantly improved ovarian reserve and embryo quality, with no ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2352320425001907

Research trends on platelet-rich plasma in improving ...

The summary results of the Meta-Analysis indicated that injection of intraovarian PRP could promote ovarian regeneration and improve the reproductive outcomes ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12109040/

Platelet-Rich Plasma (PRP) in Reproductive Medicine

PRP has the potential to stimulate follicular growth, improving ovarian function and increasing egg production, even in cases of diminished ...

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fertstert.org

fertstert.org/article/S0015-0282(21)00684-1/fulltext

IVF OUTCOMES IN 510 WOMEN WITH POOR OVARIAN ...

In 510 women with POR and mean age of 40.3, ovarian injection of PRP resulted in improvement of ovarian reserve parameters, a pregnacy rate of 20.5% and ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04275700

Study of PRP in Women With Evidence of Diminished ...

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 ...

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ovarianresearch.biomedcentral.com

ovarianresearch.biomedcentral.com/articles/10.1186/s13048-024-01423-2

Platelet-rich plasma (PRP) treatment of the ovaries ...

PRP treatment resulted in a statistically significant improvement in the main fertility parameters of diminished ovarian reserve women.

8.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S016503782500227X

The impact of platelet-rich plasma (PRP) on ovarian ...

Early clinical data show better reproductive outcomes post-intraovarian PRP in women with low ovarian reserve or POI. •. Validating PRP's role in fertility ...