What side effects are associated with this type of intervention?

Common treatments for male infertility, such as pentoxyfylline, coenzyme Q10, L-carnitine, FSH, tamoxifen, and kallikrein, can have various side effects. Pentoxyfylline may cause gastrointestinal discomfort and dizziness. Coenzyme Q10 and L-carnitine are generally well-tolerated but can occasionally cause gastrointestinal issues. FSH therapy can lead to injection site reactions, mood swings, and gynecomastia. Tamoxifen may cause hot flashes, nausea, and an increased risk of thromboembolic events. Kallikrein's side effects are less well-documented but may include allergic reactions. PRP injections, which are being studied for their potential to improve sperm retrieval rates, are generally considered safe but can cause pain at the injection site, infection, and tissue damage in rare cases.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for male infertility that directly involve autologous platelet-rich plasma (PRP) injections. PRP therapy is still considered experimental for this indication. Current FDA-approved treatments for male infertility typically include hormonal therapies, medications to address underlying conditions, and assisted reproductive technologies such as in vitro fertilization (IVF).

What other types of research exist?

Promising novel alternatives to Autologous Platelet Rich Plasma (PRP) Injection for male infertility patients in 2024 include stem cell therapy and thrombopoietic growth factors. These therapies aim to promote tissue repair and regeneration, although their efficacy and safety in the context of male infertility are still under investigation and require further clinical validation.

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Other

Platelet Rich Plasma Treatment for Male Infertility

N/A

Recruiting

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months after prp injection

Awards & highlights

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort, swelling, or bruising at the injection site. There could also be risks associated with needle insertion into the testicles, such as infection or damage to the tissue.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months after prp injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months after prp injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months after prp injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

sperm present

Trial Design

1Treatment groups

Experimental Treatment

Group I: Platelet rich plasma treatment armExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Platelet rich plasma

2010

Completed Phase 4

~1300

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for male infertility, such as autologous platelet-rich plasma (PRP) injections, work by releasing growth factors and cytokines to promote tissue repair and regeneration in the testes, thereby improving sperm quality and function. Other treatments, like Mucuna pruriens seed powder, reactivate enzymatic activity and balance reproductive hormones, while empiric therapies with gonadotropins, antiestrogens, and antioxidants enhance seminal parameters and increase pregnancy rates. These treatments are vital for male infertility patients as they address hormonal imbalances, oxidative stress, and tissue damage, improving the likelihood of successful conception.

Plasma-Rich in Growth Factors Ameliorates Detrimental Effects of Cryopreservation on Human Sperm: A Prospective Study.Effect of platelet-rich plasma (PRP) on post-thaw quality, kinematics and in vivo fertility of fertile and subfertile buffalo (Bubalus bubalis) spermatozoa.Comparative Effect of Photobiomodulation on Human Semen Samples Pre- and Post-Cryopreservation.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,448 Previous Clinical Trials

17,492,384 Total Patients Enrolled

Media Library

Platelet Rich Plasma (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05479474 — N/A

Male Infertility Research Study Groups: Platelet rich plasma treatment arm

Male Infertility Clinical Trial 2023: Platelet Rich Plasma Highlights & Side Effects. Trial Name: NCT05479474 — N/A

Platelet Rich Plasma (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05479474 — N/A

Male Infertility Patient Testimony for trial: Trial Name: NCT05479474 — N/A

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