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

Trial Summary

What is the purpose of this trial?

To determine the effectiveness of an intrauterine PRP infusion on endometrial thickness and in vitro fertilization (IVF) outcomes in a population of infertile women with a history of unresponsive thin endometrium.

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.

What data supports the effectiveness of PRP therapy for infertility?

Research suggests that platelet-rich plasma (PRP) therapy, which uses a concentrated portion of the patient's own blood, may help improve conditions related to infertility, such as poor ovarian reserve and thin endometrium, by potentially enhancing oocyte quality and endometrial thickness. ^{1 2 3 4 5}

Is PRP therapy generally safe for humans?

PRP therapy, which uses a concentration of a person's own platelets, is considered to have low risks of disease transmission, immune reactions, and allergies because it is made from the patient's own blood. ^{1 6 7 8 9}

How is PRP therapy for infertility different from other treatments?

PRP therapy for infertility is unique because it uses the patient's own blood, processed to concentrate platelets, which are then infused into the uterus to improve the lining and potentially enhance pregnancy outcomes. This approach is novel as it leverages the body's natural growth factors to support fertility, unlike traditional hormone-based treatments. ^{1 4 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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 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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Does Platelet-Rich Plasma Treatment Increase In Vitro Fertilization (IVF) Success in the Infertile Population? [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Intrauterine infusion of platelet-rich plasma is a treatment method for patients with intrauterine adhesions after hysteroscopy. [2021]

3. England 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. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A narrative review of platelet-rich plasma (PRP) in reproductive medicine. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Autologous Intrauterine Platelet-Rich Plasma Instillation for Suboptimal Endometrium in Frozen Embryo Transfer Cycles: A Pilot Study. [2022]

6. Iran 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effect of platelet-rich plasma on pregnancy outcomes in infertile women with recurrent implantation failure: a randomized controlled trial. [2021]

8. Australia 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. [2021]

9. England 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. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. [2023]

11. Poland pubmed.ncbi.nlm.nih.gov

Effect of intrauterine infusion of autologous platelet-rich plasma in patients with refractory thin endometrium undergoing in vitro fertilization. [2023]

12. Japan pubmed.ncbi.nlm.nih.gov

Transcriptomic profiling analysis of human endometrial stromal cells treated with autologous platelet-rich plasma. [2023]