Platelet Rich Plasma Treatment for Male Infertility

Overseen By Satvir Basran

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Stanford University

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

10 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether injecting a special substance made from a patient's own blood into their testicles can help men who couldn't retrieve sperm in a previous procedure. The goal is to see if this treatment can improve their chances of having children through medical procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Platelet Rich Plasma for male infertility?

Research suggests that platelet-rich plasma (PRP), which contains growth factors, has high regenerative activity and may help restore sperm-producing cells. Additionally, PRP has been shown to improve sperm quality and viability when used as a supplement in sperm preservation. ^{1 2 3 4 5}

Is Platelet Rich Plasma (PRP) treatment generally safe for humans?

Research on PRP, used for conditions like hair loss, shows it has beneficial effects without major adverse reactions, suggesting it is generally safe for humans. ^{6 7 8 9 10}

How is Platelet Rich Plasma treatment unique for male infertility?

Platelet Rich Plasma (PRP) treatment is unique for male infertility because it uses the patient's own blood, enriched with platelets that contain growth factors, to potentially regenerate and restore the cells involved in sperm production. This approach is different from traditional treatments as it focuses on enhancing the body's natural healing processes. ^{1 2 3 9 11}

Eligibility Criteria

This trial is for men over 18 with nonobstructive azoospermia (NOA) who have had an unsuccessful testicular sperm extraction (TESE). It's aimed at those seeking new options after traditional fertility treatments haven't worked.

Inclusion Criteria

You are over the age of 18 and have a history of NOA.

Exclusion Criteria

I'm sorry, but there is no criterion provided. Could you please provide me with more information?

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intratesticular injection of autologous platelet rich plasma (PRP) after blood draw and preparation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for sperm retrieval rates and IVF outcomes after PRP treatment

3 months

1 visit (in-person)

Treatment Details

Interventions

• Platelet Rich Plasma

Trial Overview The study tests whether injecting platelet rich plasma (PRP) directly into the testes can increase the chances of finding sperm during a repeat TESE and improve in vitro fertilization (IVF) results for these men.

Participant Groups

Group I: Platelet rich plasma treatment arm Experimental Treatment 1 Intervention

After consent in obtained, the patient will undergo a blood draw (12 tsp) to prepare the PRP infusion. The use of a centrifuge and an Arteriocyte Magellan kit are necessary for the PRP preparation. After injection of local anesthesia, PRP will be injected into each testicle.

Platelet Rich Plasma is already approved in United States, European Union for the following indications:

Approved in United States as Platelet Rich Plasma for:

• Facet-mediated lumbar low back pain
• Degenerative joint disease
• Chronic pain

Approved in European Union as Platelet Rich Plasma for:

• Orthopedic conditions
• Musculoskeletal disorders
• Pain management

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

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]

Autologous platelet-rich plasma (PRP) therapy shows potential benefits in reproductive medicine, particularly in increasing endometrial thickness and improving pregnancy rates in women with thin endometrium.

In women with poor ovarian reserve, PRP therapy may enhance anti-Mullerian hormone (AMH) levels and reduce follicle-stimulating hormone (FSH) levels, suggesting a positive trend towards improved clinical outcomes, although more rigorous studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A narrative review of platelet-rich plasma (PRP) in reproductive medicine. Sharara, FI., Lelea, LL., Rahman, S., et al.[2022]

References

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

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

2. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Influence of platelets growth factors on spermatogenesis after electronic irradiation]. [2022]

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

A narrative review of platelet-rich plasma (PRP) in reproductive medicine. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of platelet-rich plasma (PRP) on post-thaw quality, kinematics and in vivo fertility of fertile and subfertile buffalo (Bubalus bubalis) spermatozoa. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Improvement of human sperm properties with platelet-rich plasma as a cryoprotectant supplement. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of autologous platelet-rich plasma on human sperm quality during cryopreservation. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Positive effect of autologous platelet rich plasma on Saanen buck semen cryopreservation in non-breeding season. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Efficacy of platelet-rich plasma in treatment of androgenic alopecia. [2022]

9. India pubmed.ncbi.nlm.nih.gov

Platelet-rich Plasma by Single Spin Process in Male Pattern Androgenetic Alopecia: Is it an Effective Treatment? [2022]

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

Efficacy of Activated 3X Platelet-Rich Plasma in the Treatment of Androgenic Alopecia. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Platelet-rich plasma in animal reproductive medicine: Prospective and applications. [2022]