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

90 Participants Needed

Trial Summary

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.

What data supports the effectiveness of this treatment for diminished ovarian reserve?

Research suggests that injecting platelet-rich plasma (PRP) into the ovaries may help improve ovarian function and increase the chances of pregnancy in women with low ovarian reserve. Studies have shown that PRP can positively impact markers of ovarian reserve, oocyte (egg) quality, and embryo yield, potentially leading to better outcomes in fertility treatments. ^{1 2 3 4 5}

Is PRP therapy safe for humans?

PRP therapy, which uses a person's own blood, is generally considered safe with low risks of disease transmission, immune reactions, or allergies. ^{1 3 5 6 7}

How is PRP treatment different from other treatments for diminished ovarian reserve?

PRP treatment is unique because it involves injecting a concentrated portion of the patient's own blood (platelet-rich plasma) directly into the ovaries, which may help improve ovarian function and increase pregnancy chances. This approach is novel compared to traditional fertility treatments and carries a lower risk of disease transmission and allergic reactions since it uses the patient's own blood. ^{1 2 3 5 8}

What is the purpose of this trial?

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).

Research Team

David H Barad, MD MS

Principal Investigator

Center for Human Reproduction

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

2. 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]

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

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

4. England 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. [2022]

5. 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]

6. Brazil pubmed.ncbi.nlm.nih.gov

Protective Effects of Platelet-rich plasma for in vitro Fertilization of Rats with Ovarian Failure Induced by Cyclophosphamide. [2023]

7. 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]

8. Ireland pubmed.ncbi.nlm.nih.gov

Intra-ovarian infusion of autologous platelet-rich plasma in women with poor ovarian reserve: A before and after study. [2022]