Ovarian PRP for Diminished Ovarian Reserve

(oPRP Trial)

Overseen by Jesse Hade, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Generation Next Fertility

Disqualifiers: Premature ovarian failure, Menopause, others

Trial Summary

What is the purpose of this trial?

This prospective double-blinded randomized placebo control study aims to determine if In Vitro Fertilization (IVF) outcomes are improved by ovarian platelet-rich plasma injections (oPRP) for women diagnosed with diminished ovarian reserve (DOR). Women with DOR notoriously have the lowest chance of pregnancy and live birth compared to age-matched peers with a normal or robust ovarian reserve.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment oPRP for Diminished Ovarian Reserve?

Research suggests that intraovarian injections of platelet-rich plasma (PRP) may improve ovarian function in women with low ovarian reserve, potentially increasing their chances of pregnancy. Studies have shown that PRP can positively affect ovarian markers and outcomes in women with poor ovarian response and premature ovarian insufficiency. ^{1 2 3 4 5}

Is intraovarian PRP treatment safe for humans?

Intraovarian PRP treatment is considered safe because it uses the patient's own blood, which minimizes the risk of disease transmission and allergic reactions. Studies have shown that it is a natural treatment with no significant safety concerns reported. ^{1 2 4 6 7}

How does the ovarian PRP treatment differ from other treatments for diminished ovarian reserve?

Ovarian PRP treatment is unique because it involves injecting platelet-rich plasma (PRP) directly into the ovaries, which may help improve ovarian function and increase the chances of pregnancy in women with diminished ovarian reserve. This approach is different from traditional fertility treatments as it uses the body's own platelets to potentially rejuvenate ovarian tissue, offering an alternative to options like oocyte donation. ^{1 2 5 8 9}

Research Team

Jesse Hade, MD

Principal Investigator

Generation Next Fertility

Eligibility Criteria

This trial is for women aged 35-42 with a clinical diagnosis of diminished ovarian reserve or poor ovarian response, which typically results in lower pregnancy and live birth rates.

Inclusion Criteria

I have been diagnosed with low ovarian reserve.

I am a woman aged between 35 and 42.

I have been diagnosed with poor ovarian response.

Exclusion Criteria

I have been diagnosed with early menopause.

I have been clinically diagnosed with menopause.

I am under 35 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Baseline ultrasound and blood work at the time of menses, approximately one month prior to starting IVF cycle

4 weeks

1 visit (in-person)

Treatment

Participants receive ovarian injections of either oPRP or placebo, followed by IVF cycle with monitoring and oocyte retrieval

12 months

Multiple visits (in-person) for monitoring and procedures

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of ovarian response and embryo availability

12 months

Treatment Details

Interventions

• oPRP (Other)

Trial Overview The study is testing if injecting platelet-rich plasma (oPRP) into the ovaries can improve IVF outcomes compared to a placebo. Women are randomly assigned to receive either oPRP or a serum without active ingredients.

Participant Groups

Group I: oPRP injections Experimental Treatment 1 Intervention

Patients own prepared PRP will be injected into each ovary

Group II: Placebo Placebo Group 2 Interventions

Patient's serum will be injected into the ovary (not rich with platelets)

Who Is Running the Clinical Trial?

Generation Next Fertility

Lead Sponsor

Trials

1

Recruited

230+

Igenomix

Industry Sponsor

Trials

38

Recruited

16,800+

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]

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 involving 20 poor ovarian responder (POR) women, intra-ovarian injection of platelet-rich plasma (PRP) was found to be safe and showed a tendency to improve ovarian reserve markers, including anti-Mullerian hormone (AMH) and estradiol levels, as well as the number and quality of oocytes.

Despite these improvements, the changes were not statistically significant, and the overall pregnancy rates remained low, with only 15% achieving chemical pregnancy and 5% achieving clinical pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of intra-ovarian platelet rich plasma in women with poor ovarian response. Davari Tanha, F., Salimi Setudeh, S., Ebrahimi, 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 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 38 women aged 31-45 with low ovarian reserves, PRP (platelet-rich plasma) injections into the ovaries led to significant improvements in hormone levels and resulted in ten pregnancies, including six healthy births, demonstrating the efficacy of this treatment for premature ovarian insufficiency.

The study introduced a novel laparoscopically assisted technique for administering PRP, achieving a high platelet concentration that contributed to long-lasting results, with benefits observed up to 12 months after a single procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ovarian Rejuvenation Through Platelet-Rich Autologous Plasma (PRP)-a Chance to Have a Baby Without Donor Eggs, Improving the Life Quality of Women Suffering from Early Menopause Without Synthetic Hormonal Treatment. Petryk, N., Petryk, M.[2020]

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]

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. Netherlands pubmed.ncbi.nlm.nih.gov

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

3. Iran pubmed.ncbi.nlm.nih.gov

Effect of intra-ovarian platelet rich plasma in women with poor ovarian response. [2023]

4. 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]

5. 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]

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

Ovarian Rejuvenation Through Platelet-Rich Autologous Plasma (PRP)-a Chance to Have a Baby Without Donor Eggs, Improving the Life Quality of Women Suffering from Early Menopause Without Synthetic Hormonal Treatment. [2020]

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]

9. 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]