PRP Therapy for Infertility

(PIER Trial)

Overseen By Jason Franasiak, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Reproductive Medicine Associates of New Jersey

Must not be taking: Anticoagulants, Adjunctive therapies

Disqualifiers: Fewer than 2 cycles, Pregnancy, Thrombosis, Thrombophilia, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Proliferative phase of the cycle

62 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of platelet-rich plasma (PRP) infusion into the uterus to assist women with infertility. Specifically, it examines whether PRP can enhance uterine lining thickness and increase success rates for in vitro fertilization (IVF). Women with thin uterine linings and at least two unsuccessful IVF attempts might be suitable candidates. Participants will receive either the PRP treatment or a placebo (a saline solution) for comparison. As an unphased trial, this study provides participants the chance to contribute to groundbreaking research that could advance fertility treatments.

Do I need to stop taking my current medications for the trial?

The trial requires that you stop using any additional therapies that help with cell growth when you enroll.

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

Research has shown that Platelet Rich Plasma (PRP) therapy is usually well-tolerated. In one study, PRP injections improved ovarian health and embryo quality without major side effects. Another study found that while PRP might increase the risk of early delivery, no other significant negative effects were noted. These findings are important for those considering joining a trial, as they suggest PRP therapy is mostly safe but may carry some risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for infertility?

Researchers are excited about platelet-rich plasma (PRP) therapy for infertility because it offers a fresh approach to enhancing fertility. Unlike traditional treatments like hormone therapies and assisted reproductive technologies, PRP uses growth factors from the patient's own blood to potentially rejuvenate the uterine environment. This method is particularly appealing as it is less invasive and could improve the uterine lining, which is crucial for embryo implantation. By using the body's natural healing components, PRP therapy might offer a safer, more natural alternative to existing treatments.

What evidence suggests that this trial's treatments could be effective for infertility?

Research shows that platelet-rich plasma (PRP) therapy, which participants in this trial may receive, might assist women struggling with infertility, particularly those with a thin uterine lining. Studies have found that PRP can enhance ovarian growth and function, potentially leading to more eggs and improved ovarian performance. In some cases, PRP treatment significantly increased the chances of pregnancy and childbirth. Additionally, PRP has improved embryo quality in IVF patients. These findings suggest that PRP could be a beneficial option for women facing fertility challenges. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for women who've had at least two unsuccessful frozen embryo transfers due to thin endometrial lining or canceled cycles. They must not have certain uterine anomalies, be using other proliferation therapies, or have a history of thrombosis. Women with recent unsuccessful transfers before January 1, 2017, are excluded.

Inclusion Criteria

I've had at least 2 failed embryo transfers without a successful pregnancy.

My endometrial lining was 6 mm or less during past embryo transfers.

Exclusion Criteria

My embryo for transfer was created using sperm obtained through surgery due to non-obstructive azoospermia.

Concurrent pregnancy

I will stop any additional cancer growth treatments when I join the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an intrauterine infusion of PRP or placebo followed by a frozen embryo transfer

Proliferative phase of the cycle

Follow-up

Participants are monitored for endometrial thickness and sustained implantation rate

Approximately 9 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Normal saline Intrauterine infusion
• Platelet Rich Plasma Intrauterine infusion

Trial Overview The study tests if an intrauterine infusion of Platelet Rich Plasma (PRP) can increase the thickness of the endometrium and improve IVF outcomes compared to a normal saline solution in women with infertility issues related to thin endometrial lining.

How Is the Trial Designed?

Group I: Intervention Group Active Control 1 Intervention

an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group

Group II: Control Group Placebo Group 1 Intervention

an intrauterine infusion of normal saline will be administered to this group

Platelet Rich Plasma Intrauterine infusion is already approved in United States, European Union, China for the following indications:

Approved in United States as Platelet-Rich Plasma for:

• Orthopedic conditions (e.g., tendinopathies, osteoarthritis)
• Dermatological conditions (e.g., alopecia areata, facial rejuvenation)
• Off-label use in assisted reproductive technology (e.g., thin endometrium, repeated implantation failure)

Approved in European Union as Platelet-Rich Plasma for:

• Orthopedic conditions (e.g., tendinopathies, osteoarthritis)
• Dermatological conditions (e.g., alopecia areata, facial rejuvenation)
• Off-label use in assisted reproductive technology (e.g., thin endometrium, repeated implantation failure)

Approved in China as Platelet-Rich Plasma for:

• Assisted reproductive technology (e.g., thin endometrium, repeated implantation failure)
• Orthopedic conditions (e.g., tendinopathies, osteoarthritis)

Who Is Running the Clinical Trial?

Reproductive Medicine Associates of New Jersey

Lead Sponsor

Trials

56

Recruited

38,200+

Published Research Related to This Trial

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]

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]

In a study of 98 women with recurrent implantation failure, the use of autologous platelet-rich plasma (PRP) infused 48 hours before embryo transfer significantly improved clinical pregnancy rates (48.3% vs. 23.26%) and ongoing pregnancy rates (46.7% vs. 11.7%) compared to a control group.

The infusion of PRP also resulted in a higher implantation rate (58.3% vs. 25%), suggesting that PRP may enhance IVF outcomes for women who have previously struggled to achieve pregnancy after multiple embryo transfers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of platelet-rich plasma on pregnancy outcomes in infertile women with recurrent implantation failure: a randomized controlled trial. Zamaniyan, M., Peyvandi, S., Heidaryan Gorji, H., et al.[2021]

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]

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]

Autologous platelet-rich plasma (PRP) therapy shows potential benefits in reproductive medicine, particularly in increasing endometrial thickness and improving pregnancy rates in women with thin endometrium.

In women with poor ovarian reserve, PRP therapy may enhance anti-Mullerian hormone (AMH) levels and reduce follicle-stimulating hormone (FSH) levels, suggesting a positive trend towards improved clinical outcomes, although more rigorous studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of platelet-rich plasma (PRP) in reproductive medicine. Sharara, FI., Lelea, LL., Rahman, S., et al.[2022]

In a study involving 85 patients with repeated implantation failure and normal endometrial thickness, the intrauterine infusion of platelet-rich plasma (PRP) did not significantly improve pregnancy outcomes compared to a control group.

The rates of biochemical, clinical, and ongoing pregnancies were similar between the PRP group and the control group, indicating that PRP is not an effective treatment for enhancing IVF success in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous platelet-rich plasma infusion does not improve pregnancy outcomes in frozen embryo transfer cycles in women with history of repeated implantation failure without thin endometrium. Tehraninejad, ES., Kashani, NG., Hosseini, A., et al.[2021]

Intrauterine infusion of autologous platelet-rich plasma (PRP) significantly improved endometrial thickness from an average of 5 mm to 7.22 mm in 68 women with suboptimal endometrium, enhancing conditions for embryo transfer.

The study reported a clinical pregnancy rate of 45.31% and a positive beta hCG rate of 60.93%, suggesting that PRP treatment may effectively support successful pregnancies in women facing repeated cycle cancellations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous Intrauterine Platelet-Rich Plasma Instillation for Suboptimal Endometrium in Frozen Embryo Transfer Cycles: A Pilot Study. Tandulwadkar, SR., Naralkar, MV., Surana, AD., et al.[2022]

In a study of 66 infertile women with refractory thin endometrium, autologous intrauterine platelet-rich plasma (PRP) infusion significantly increased endometrial thickness and improved the endometrial pattern before embryo transfer, which are crucial for successful implantation.

The infusion of PRP also led to higher rates of ongoing pregnancy, chemical pregnancy, clinical pregnancy, and implantation, while reducing the miscarriage rate, indicating its potential as an effective treatment for enhancing reproductive outcomes in IVF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intrauterine infusion of autologous platelet-rich plasma in patients with refractory thin endometrium undergoing in vitro fertilization. Salman, MM., Zaki, AM., El-Gamal, HH., et al.[2023]

Intrauterine infusion of platelet-rich plasma (PRP) promotes gene expression related to cell growth and tissue regeneration in undifferentiated human endometrial stromal cells (HESCs), suggesting it may enhance embryo implantation during in vitro fertilization.

PRP also modulates gene expression in decidualized HESCs by reducing cell proliferation and inflammation, indicating its potential to improve endometrial conditions for embryo implantation depending on the menstrual cycle phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcriptomic profiling analysis of human endometrial stromal cells treated with autologous platelet-rich plasma. Kuroda, K., Matsumoto, A., Horikawa, T., et al.[2023]

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]

In a study involving 70 patients with moderate to severe intrauterine adhesions, the efficacy of intrauterine infusion of platelet-rich plasma (PRP) was compared to balloon treatment, showing no significant differences in outcomes between the two methods.

Both treatments resulted in similar rates of chemical pregnancy (around 40% for PRP and 39% for balloon), indicating that PRP can be considered a viable treatment option for intrauterine adhesions, although it does not outperform the balloon method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intrauterine infusion of platelet-rich plasma is a treatment method for patients with intrauterine adhesions after hysteroscopy. Peng, J., Li, M., Zeng, H., et al.[2021]

Citations

1. 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38544668/

Intrauterine autologous platelet-rich plasma treatment in ... In women with a history of only one implantation failure, PRP therapy significantly improved the ongoing pregnancy and live birth rate (19.5%, p ...

3. 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 ...

4. nature.com nature.com/articles/s41598-024-82630-1

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.

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

Platelet-rich plasma (PRP) treatment of the ovaries ... Platelet-rich plasma (PRP) treatment of the ovaries significantly improves fertility parameters and reproductive outcomes in diminished ovarian ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38682756/

Autologous platelet-rich plasma for assisted reproduction Intrauterine infusion of PRP may increase the risk of preterm delivery compared with no intervention (OR 8.02, 95% CI 1.72 to 37.33; 1 study, ...

7. nature.com nature.com/articles/s41598-025-02689-2

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 ...

8. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-025-02854-3

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

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

Revitalizing female fertility: platelet-rich plasma – hype or ... The study found no clinically significant effects of PRP treatment on ovarian function over the 1-year follow-up period. However, two patients ...