230 Participants Needed

Ovarian PRP for Diminished Ovarian Reserve

(oPRP Trial)

AB
JH
Overseen ByJesse Hade, MD
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Generation Next Fertility

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether injections of ovarian platelet-rich plasma (oPRP) can improve IVF outcomes for women with diminished ovarian reserve (DOR). DOR refers to having fewer eggs in the ovaries than expected for someone of the same age, making pregnancy more challenging. Participants will receive either oPRP injections or a placebo (an inactive substance) to compare results. Women diagnosed with DOR and experiencing poor ovarian response (limited egg production) may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance fertility treatments.

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 prior data suggests that ovarian PRP injections are safe for women with diminished ovarian reserve?

Research shows that ovarian platelet-rich plasma (oPRP) treatments may improve fertility in women with diminished ovarian reserve (DOR). Studies have found that oPRP injections can enhance ovarian function and increase egg production. Specifically, one study noted a significant improvement in fertility for women with DOR after receiving PRP treatment.

Early clinical data also suggest that women who received oPRP injections directly into the ovaries had better chances of becoming pregnant. This indicates that the treatment might improve pregnancy chances for those with low ovarian reserves.

Regarding safety, these studies indicate that oPRP is generally well-tolerated, with no major reports of serious side effects. This is encouraging for those considering the treatment. However, as with any medical procedure, discussing potential risks and benefits with a healthcare provider is important.12345

Why are researchers excited about this trial?

Most treatments for diminished ovarian reserve involve hormone therapies that aim to stimulate the ovaries. However, oPRP is unique because it harnesses the patient’s own platelet-rich plasma (PRP) and injects it directly into the ovaries. This approach could potentially rejuvenate ovarian tissue and improve egg quality by using the body’s natural growth factors. Researchers are excited about this treatment because it offers a personalized and potentially less invasive alternative to traditional hormone treatments, with the promise of enhancing fertility outcomes.

What evidence suggests that oPRP might be an effective treatment for diminished ovarian reserve?

Research shows that ovarian platelet-rich plasma (oPRP) injections, which participants in this trial may receive, can help women with low ovarian reserves increase their chances of getting pregnant. Studies have found that oPRP treatment improves ovarian function and leads to more pregnancies and live births. For example, one study found that about 16.6% of women had a live birth after PRP treatment. Another analysis showed that about 21% of women became pregnant after the treatment. These findings suggest that oPRP could be a promising option for women with low ovarian reserves.46789

Who Is on the Research Team?

JH

Jesse Hade, MD

Principal Investigator

Generation Next Fertility

Are You a Good Fit for This Trial?

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.
See 1 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • oPRP
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: oPRP injectionsExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Generation Next Fertility

Lead Sponsor

Trials
1
Recruited
230+

Igenomix

Industry Sponsor

Trials
38
Recruited
16,800+

Published Research Related to This Trial

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.
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]
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]
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.
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]

Citations

Platelet-rich plasma (PRP) treatment of the ovaries ...PRP treatment resulted in a statistically significant improvement in the main fertility parameters of diminished ovarian reserve women.
Research trends on platelet-rich plasma in improving ...The summary results of the Meta-Analysis indicated that injection of intraovarian PRP could promote ovarian regeneration and improve the reproductive outcomes ...
Comparative efficacy of single vs. double autologous ...This study aims to compare the efficacy of single versus double PRP ovarian injections in improving ovarian reserve, response to stimulation, and IVF/ICSI ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/38214306/
The efficacy of platelet rich plasma on women with poor ...Results: A total of 10 trials were enrolled in the present meta-analysis. Following PRP treatment, live birth rate was found to be 16.6% (95% CI 8.8%-26.1%), ...
Evaluation of intraovarian injection of platelet-rich plasma for ...The meta-analysis revealed a pregnancy ratio of 0.21 and a live birth ratio of 0.18 in women with poor ovarian reserve after PRP injection.
Platelet-Rich Plasma (PRP) in Reproductive MedicinePRP has the potential to stimulate follicular growth, improving ovarian function and increasing egg production, even in cases of diminished ...
The impact of platelet-rich plasma (PRP) on ovarian ...Early clinical data show better reproductive outcomes post-intraovarian PRP in women with low ovarian reserve or POI. •. Validating PRP's role in fertility ...
Platelet-rich plasma (PRP) treatment of the ovaries ...PRP treatment resulted in a statistically significant improvement in the main fertility parameters of diminished ovarian reserve women.
P-793 Ovarian rejuvenation in poor responders with plasma ...Ovarian PRP could improve fertility outcomes and can be a potential option for women with poor ovarian reserve.
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