90 Participants Needed

PRP for Diminished Ovarian Reserve

(PRP4POA Trial)

DB
NG
Overseen ByNorbert Gleicher, MD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Center for Human Reproduction

Trial Summary

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).

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.12345

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.13567

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.12358

Research Team

DH

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.
See 4 more

Exclusion Criteria

I have an autoimmune disease like lupus.
I do not have any ongoing infections.
I have a blood disease.
See 7 more

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 OverviewThe 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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PRP groupExperimental Treatment1 Intervention
Platelet RICH Plasma prepared using RegenLab FDA approved device.
Group II: PPP groupPlacebo Group1 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:

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Approved in United States as Platelet-Poor Plasma for:
  • Coagulation testing
  • Orthopedic surgery
  • Cosmetic surgery
  • Wound healing
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Approved in European Union as Platelet-Poor Plasma for:
  • Coagulation testing
  • Orthopedic surgery
  • Cosmetic surgery
  • Wound healing

Find a Clinic Near You

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.
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.
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.
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]

References

Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. [2023]
The use of intraovarian injection of autologous platelet rich plasma (PRP) in patients with poor ovarian response and premature ovarian insufficiency. [2022]
Does Platelet-Rich Plasma Treatment Increase In Vitro Fertilization (IVF) Success in the Infertile Population? [2023]
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]
Intraovarian Injection of Autologous Platelet-Rich Plasma Improves Therapeutic Approaches in The Patients with Poor Ovarian Response: A Before-After Study. [2022]
Protective Effects of Platelet-rich plasma for in vitro Fertilization of Rats with Ovarian Failure Induced by Cyclophosphamide. [2023]
The efficacy of intrauterine infusion of platelet rich plasma in women undergoing assisted reproduction: a systematic review and meta-analysis. [2023]
Intra-ovarian infusion of autologous platelet-rich plasma in women with poor ovarian reserve: A before and after study. [2022]