PRP for Diminished Ovarian Reserve

(PRP4AGE Trial)

Overseen By David H Barad, MD MS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Center for Human Reproduction

Must not be taking: Anticoagulants, Antiaggregants, Steroids, others

Disqualifiers: Blood diseases, Cancer, Sepsis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

80 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 treatment, you may not be eligible to participate.

What data supports the effectiveness of the treatment A-PRP for Diminished Ovarian Reserve?

Research suggests that intraovarian platelet-rich plasma (PRP) treatment may help improve ovarian function and increase the chances of pregnancy in women with low ovarian reserve. Studies have shown improvements in ovarian reserve markers and better outcomes in fertility treatments after PRP infusion. ^{1 2 3 4 5}

Is PRP treatment safe for humans?

PRP (platelet-rich plasma) treatment is considered generally safe because it uses your own blood, which means there's a very low risk of disease transmission or allergic reactions. ^{1 3 5 6 7}

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

A-PRP (autologous platelet-rich plasma) is unique because it involves injecting a patient's own blood components directly into the ovaries to potentially improve ovarian function and fertility. This method is considered safer with lower risks of disease transmission and allergic reactions compared to other treatments, as it uses the patient's own biological material. ^{2 3 6 8 9}

What is the purpose of this trial?

This trial involves injecting a special preparation of a woman's own blood into her ovaries to help improve fertility. It targets women who have not responded well to typical fertility treatments. The treatment works by using growth factors in the blood to stimulate egg growth in the ovaries.

Research Team

Norbert Gleicher, MD

Principal Investigator

Medical Director

Eligibility Criteria

This trial is for women under 55 with diminished ovarian reserve, evidenced by a poor response to ovulation induction and specific hormone levels (FSH > 12, AMH < 1.1). Participants should not have taken Aspirin or Motrin for a week before treatment. Women with blood diseases, autoimmune conditions like lupus, or those on certain medications are excluded.

Inclusion Criteria

I am 54 years old or younger.

I haven't taken Aspirin or Motrin in the last week.

I am 54 years old or younger.

Exclusion Criteria

I have a cancer affecting my bones or blood.

I am older than 54 years.

I have a very low platelet count.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive injections of autologous Platelet Rich Plasma (A-PRP) in both ovaries under ultrasound guidance

12 weeks

Multiple visits for injections and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in serum AMH and emergence of new ovarian follicles

12 weeks

Long-term Follow-up

Participants are monitored for retrieval of oocytes and establishment of clinical pregnancy

12 months

Treatment Details

Interventions

• A-PRP

Trial Overview The study tests if injecting Platelet Rich Plasma (PRP) into the ovaries can stimulate follicle growth in women who've had inadequate responses to fertility treatments. Following PRP injections, routine fertility drugs will be used until hCG trigger.

Participant Groups

Group I: A-PRP Experimental Treatment 1 Intervention

The cortex of each ovary will be injected with autologous platelet rich plasma.

Who Is Running the Clinical Trial?

Center for Human Reproduction

Lead Sponsor

Trials

14

Recruited

1,200+

Findings from Research

In a study of 80 women aged 28-54 with extremely low functional ovarian reserve, intraovarian injection of platelet-rich plasma (PRP) did not show any clinically significant improvements in ovarian function over a 1-year follow-up period.

Despite the lack of overall efficacy, two patients achieved pregnancy after PRP treatment, suggesting that while sporadic pregnancies are possible in this population, the study does not confirm that PRP was the cause of these pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary report of intraovarian injections of autologous platelet-rich plasma (PRP) in extremely poor prognosis patients with only oocyte donation as alternative: a prospective cohort study. Barad, DH., Albertini, DF., Molinari, E., et al.[2022]

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]

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]

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 pilot study involving 4 women with diminished ovarian reserve, the injection of autologous platelet-rich plasma (PRP) into the ovaries led to improved ovarian function, as indicated by increased serum AMH levels and decreased FSH levels, allowing for the retrieval of viable oocytes for IVF.

This is the first report of direct PRP injection into human ovaries for infertility treatment, showing promising results in enhancing ovarian reserve and function, although further research is needed to understand the specific components of PRP that contribute to these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First data on in vitro fertilization and blastocyst formation after intraovarian injection of calcium gluconate-activated autologous platelet rich plasma. Sills, ES., Rickers, NS., Li, X., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Preliminary report of intraovarian injections of autologous platelet-rich plasma (PRP) in extremely poor prognosis patients with only oocyte donation as alternative: a prospective cohort study. [2022]

2. 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]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

A Systematic Review Evaluating the Efficacy of Intra-Ovarian Infusion of Autologous Platelet-Rich Plasma in Patients With Poor Ovarian Reserve or Ovarian Insufficiency. [2021]

5. 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]

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. Netherlands pubmed.ncbi.nlm.nih.gov

The protective effect of platelet-rich plasma administrated on ovarian function in female rats with Cy-induced ovarian damage. [2021]

8. England pubmed.ncbi.nlm.nih.gov

First data on in vitro fertilization and blastocyst formation after intraovarian injection of calcium gluconate-activated autologous platelet rich plasma. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Live Birth in Woman With Premature Ovarian Insufficiency Receiving Ovarian Administration of Platelet-Rich Plasma (PRP) in Combination With Gonadotropin: A Case Report. [2021]