PRP for Diminished Ovarian Reserve

(PRP4POA Trial)

Overseen By Norbert Gleicher, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Center for Human Reproduction

Must not be taking: Anticoagulants, Antiaggregants

Disqualifiers: Thrombocytopenia, Blood diseases, Autoimmune, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Platelet Rich Plasma (PRP) can assist women with diminished ovarian reserve, a condition where the ovaries have fewer eggs than usual. Participants will receive either PRP, which is rich in platelets thought to aid tissue healing and growth, or a placebo called Platelet Poor Plasma (PPP). Women who have had fewer than six eggs develop in past fertility treatments and wish to pursue IVF might be suitable candidates. The research aims to determine if PRP can improve their chances of pregnancy. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance 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 treatments, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research is exploring how Platelet Rich Plasma (PRP) might enhance ovarian function, particularly for women with low ovarian reserve. Some studies have examined the safety of injecting PRP into the ovaries. Although large, randomized studies have not yet confirmed its safety, smaller studies suggest it is generally well-tolerated. Most participants in these studies did not report serious side effects. However, PRP is not widely approved for this use, so further research is necessary to confirm these findings.

For Platelet Poor Plasma (PPP), specific safety information is limited because it often serves as a comparison in studies. Both PRP and PPP are prepared using an FDA-approved device, indicating safe preparation. Always consult a healthcare professional to understand potential risks and benefits before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for diminished ovarian reserve, such as hormone therapy or IVF, PRP (Platelet Rich Plasma) uses components from your own blood to potentially rejuvenate the ovaries. Researchers are excited about PRP because it leverages the body's natural growth factors, offering a unique and potentially less invasive approach to improving ovarian function. On the other hand, PPP (Platelet Poor Plasma) serves as a placebo comparator, helping to measure the true effectiveness of PRP. This innovative angle could open new pathways for fertility treatments with fewer side effects than traditional methods.

What evidence suggests that this trial's treatments could be effective for diminished ovarian reserve?

Research has shown that Platelet Rich Plasma (PRP), which participants in this trial may receive, can improve ovarian function in women with a low number of eggs. Studies have found that PRP injections encourage the growth of follicles, the parts of the ovaries that produce eggs. One study found that PRP significantly improved ovarian response and embryo quality in women undergoing IVF (in vitro fertilization). Another study reported a clear improvement in key fertility factors following PRP treatment. These findings suggest that PRP might boost fertility in women with this condition. Meanwhile, another group in this trial will receive Platelet Poor Plasma (PPP) as a comparator. ^{1 3 4 6 7}

Who Is on the Research Team?

David H Barad, MD MS

Principal Investigator

Center for Human Reproduction

Are You a Good Fit for This Trial?

Women under 45 with poor ovarian reserve, who haven't taken Aspirin or Motrin for a week, want to get pregnant through IVF, have had fewer than 6 eggs from past treatments, and have specific hormone levels (FSH > 12 and AMH < 1.0). It's not for those over age 45 or with certain blood diseases, clotting disorders, cancer, infections like sepsis, or autoimmune conditions.

Inclusion Criteria

I want to get pregnant using IVF.

FSH > 12

I am 44 years old or younger.

Exclusion Criteria

I have an autoimmune disease like lupus.

I do not have any ongoing infections.

I have a blood disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Platelet Rich Plasma (PRP) or Platelet Poor Plasma (PPP) for ovarian function improvement

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including embryo production and hormone levels

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PPP - Platelet Poor Plasma
• PRP - Platelet Rich Plasma

Trial Overview

The trial is testing the effects of injecting either Platelet Rich Plasma (PRP) or Platelet Poor Plasma (PPP) directly into the ovaries of women with diminished ovarian reserve to see if it can improve their fertility outcomes in IVF treatment.

How Is the Trial Designed?

Group I: PRP group Experimental Treatment 1 Intervention

Platelet RICH Plasma prepared using RegenLab FDA approved device.

Group II: PPP group Placebo Group 1 Intervention

Platelet POOR Plasma prepared using RegenLab FDA approved device.

PPP - Platelet Poor Plasma is already approved in United States, European Union for the following indications:

Approved in United States as Platelet-Poor Plasma for:

• Coagulation testing
• Orthopedic surgery
• Cosmetic surgery
• Wound healing

Approved in European Union as Platelet-Poor Plasma for:

• Coagulation testing
• Orthopedic surgery
• Cosmetic surgery
• Wound healing

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 96 women with poor ovarian response (POR), intra-ovarian administration of platelet-rich plasma (PRP) significantly increased the total number of oocytes and the number of mature (MII) oocytes across most groups, indicating its potential efficacy in enhancing ovarian function.

Despite the increase in oocyte numbers, changes in hormone levels (LH, FSH, AMH, and estradiol) were not significant, and only 14.6% of participants achieved clinical pregnancy, suggesting that while PRP may improve oocyte yield, its impact on overall fertility outcomes needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of intra-ovarian platelet-rich plasma administration on oocytes-dependent variables in patients with poor ovarian response: A retrospective study according to the POSEIDON criteria. Farimani, M., Nazari, A., Mohammadi, S., et al.[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]

Platelet-rich plasma (PRP) significantly improves clinical pregnancy rates and live birth rates in women undergoing assisted reproduction, with a relative risk of 1.84 and 1.75 respectively, based on data from 23 studies.

Women with repeated implantation failure showed even greater benefits from PRP, with improved pregnancy rates and reduced miscarriage rates, indicating that PRP may be particularly effective for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of intrauterine infusion of platelet rich plasma in women undergoing assisted reproduction: a systematic review and meta-analysis. Shalma, NM., Salamah, HM., Alsawareah, A., et al.[2023]

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]

Intraovarian injection of platelet-rich plasma (PRP) significantly improved oocyte count and quality in women with diminished ovarian reserve, with a 300% increase in oocytes for pregnant patients and a 125% increase for nonpregnant patients after treatment.

The study, which analyzed 60 out of 120 cases over a period from 2015 to 2020, found that PRP treatment also led to a significant increase in endometrial thickness and a decrease in follicle-stimulating hormone (FSH) levels, suggesting a positive impact on ovarian function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Platelet-Rich Plasma Treatment Increase In Vitro Fertilization (IVF) Success in the Infertile Population? Safarova, S., Cevher Akdulum, MF., Guler, I., 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 study involving 28 female rats, platelet-rich plasma (PRP) was found to significantly protect ovarian function and improve oocyte count against damage caused by cyclophosphamide (CYC), a drug known to adversely affect fertility.

The results showed that rats treated with CYC plus PRP had a higher number of fertilized oocytes and better quality embryos compared to those treated with CYC alone, indicating that PRP enhances the effectiveness of in vitro fertilization procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective Effects of Platelet-rich plasma for in vitro Fertilization of Rats with Ovarian Failure Induced by Cyclophosphamide. Budak, Ö., Bostancı, MS., Toprak, V., et al.[2023]

Citations

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

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eurjmedres.biomedcentral.com

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Evaluation of intraovarian injection of platelet-rich plasma for ...

The objective of this study was to evaluate the effect of the intraovarian injection of platelet-rich plasma (PRP) on ovarian reserve and reproductive outcomes

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Intraovarian platelet-rich plasma injection significantly ...

This study evaluated the effectiveness of intraovarian platelet-rich plasma (PRP) injection in improving ovarian response and embryo quality in IVF patients.

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frontiersin.org

frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2023.1292168/full

The effect of ovarian injection of autologous platelet rich ...

Conclusion: The pooled results suggest that intra-ovarian injection of PRP can promote ovarian regeneration and improve the reproductive ...

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pubmed.ncbi.nlm.nih.gov

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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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clinicaltrials.gov

clinicaltrials.gov/study/NCT05279560

Ovarian PRP (Platelet Rich Plasma) Injection for Follicular ...

To date, there is no randomized placebo-controlled trial available that has evaluated intra-ovarian PRP injection in terms of efficacy and safety for premature ...

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rbmojournal.com/article/S1472-6483(24)00002-6/fulltext

Revitalizing female fertility: platelet-rich plasma – hype or ...

'An audit of clinical outcomes following ovarian administration of platelet-rich plasma (PRP) in women with severe diminished ovarian reserve.