PRP Therapy for Infertility (PIER Trial)
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Reproductive Medicine Associates of New Jersey
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?To determine the effectiveness of an intrauterine PRP infusion on endometrial thickness and in vitro fertilization (IVF) outcomes in a population of infertile women with a history of unresponsive thin endometrium.
How is PRP therapy for infertility different from other treatments?
PRP therapy for infertility is unique because it uses the patient's own blood, processed to concentrate platelets, which are then infused into the uterus to improve the lining and potentially enhance pregnancy outcomes. This approach is novel as it leverages the body's natural growth factors to support fertility, unlike traditional hormone-based treatments.
5691011Is PRP therapy generally safe for humans?
PRP therapy, which uses a concentration of a person's own platelets, is considered to have low risks of disease transmission, immune reactions, and allergies because it is made from the patient's own blood.
2471112What data supports the effectiveness of PRP therapy for infertility?
Research suggests that platelet-rich plasma (PRP) therapy, which uses a concentrated portion of the patient's own blood, may help improve conditions related to infertility, such as poor ovarian reserve and thin endometrium, by potentially enhancing oocyte quality and endometrial thickness.
135811Do I need to stop taking my current medications for the trial?
The trial requires that you stop using any additional therapies that help with cell growth when you enroll.
Eligibility Criteria
This trial is for women who've had at least two unsuccessful frozen embryo transfers due to thin endometrial lining or canceled cycles. They must not have certain uterine anomalies, be using other proliferation therapies, or have a history of thrombosis. Women with recent unsuccessful transfers before January 1, 2017, are excluded.Participant Groups
The study tests if an intrauterine infusion of Platelet Rich Plasma (PRP) can increase the thickness of the endometrium and improve IVF outcomes compared to a normal saline solution in women with infertility issues related to thin endometrial lining.
2Treatment groups
Active Control
Placebo Group
Group I: Intervention GroupActive Control1 Intervention
an intrauterine infusion of platelet rich plasma (PRP) will be administered to this group
Group II: Control GroupPlacebo Group1 Intervention
an intrauterine infusion of normal saline will be administered to this group
Platelet Rich Plasma Intrauterine infusion is already approved in United States, European Union, China for the following indications:
🇺🇸 Approved in United States as Platelet-Rich Plasma for:
- Orthopedic conditions (e.g., tendinopathies, osteoarthritis)
- Dermatological conditions (e.g., alopecia areata, facial rejuvenation)
- Off-label use in assisted reproductive technology (e.g., thin endometrium, repeated implantation failure)
🇪🇺 Approved in European Union as Platelet-Rich Plasma for:
- Orthopedic conditions (e.g., tendinopathies, osteoarthritis)
- Dermatological conditions (e.g., alopecia areata, facial rejuvenation)
- Off-label use in assisted reproductive technology (e.g., thin endometrium, repeated implantation failure)
🇨🇳 Approved in China as Platelet-Rich Plasma for:
- Assisted reproductive technology (e.g., thin endometrium, repeated implantation failure)
- Orthopedic conditions (e.g., tendinopathies, osteoarthritis)
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Reproductive Medicine Associates of New JerseyBasking Ridge, NJ
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Who is running the clinical trial?
Reproductive Medicine Associates of New JerseyLead Sponsor
References
Autologous Intrauterine Platelet-Rich Plasma Instillation for Suboptimal Endometrium in Frozen Embryo Transfer Cycles: A Pilot Study. [2022]This pilot study was to evaluate the effectiveness of intrauterine infusion of autologous platelet-rich plasma (PRP) in infertile women undergoing frozen embryo transfer cycles with suboptimal endometrium.
Effect of platelet-rich plasma on pregnancy outcomes in infertile women with recurrent implantation failure: a randomized controlled trial. [2021]This study was directed to assess the efficacy of autologous platelet-rich plasma (PRP) on pregnancy rate in recurrent implantation failure. Between 2016 and 2019, a total of 98 women who unsuccessful to be pregnant after three or more high-quality embryo transfers undergoing frozen-thawed embryo transfer with or without an intrauterine infusion of platelet-rich plasma. Thus, 0.5 ml of platelet-rich plasma at 4-6 times higher concentration than peripheral blood infused intrauterine 48 h before embryo transfer. A control group underwent standard protocol.
Intrauterine infusion of platelet-rich plasma is a treatment method for patients with intrauterine adhesions after hysteroscopy. [2021]To evaluate the efficacy of an intrauterine infusion of platelet-rich plasma (PRP) in patients with intrauterine adhesions (IUAs).
Autologous platelet-rich plasma infusion does not improve pregnancy outcomes in frozen embryo transfer cycles in women with history of repeated implantation failure without thin endometrium. [2021]The effect of intrauterine infusion of platelet-rich plasma (PRP) which has been shown to improve the pregnancy outcomes in patients suffering from repeated implantation failure (RIF), is intended to be studied in patients with normal endometrial thickness.
A narrative review of platelet-rich plasma (PRP) in reproductive medicine. [2022]Platelet-rich plasma (PRP) has become a novel treatment in various aspects of medicine including orthopedics, cardiothoracic surgery, plastic surgery, dermatology, dentistry, and diabetic wound healing. PRP is now starting to become an area of interest in reproductive medicine more specifically focusing on infertility. Poor ovarian reserve, menopause, premature ovarian failure, and thin endometrium have been the main areas of research. The aim of this article is to review the existing literature on the effects of autologous PRP in reproductive medicine providing a summation of the current studies and assessing the need for additional research.
Ovarian response to intraovarian platelet-rich plasma (PRP) administration: hypotheses and potential mechanisms of action. [2023]Platelet-rich plasma (PRP) therapy has been used as an adjunct to fertility treatments in women with very low ovarian reserve and premature ovarian insufficiency. Recent literature in both humans and animals suggest that intraovarian PRP administration in the setting of poor ovarian reserve may help ovarian function and increase the chances of pregnancy.
Intraovarian Injection of Autologous Platelet-Rich Plasma Improves Therapeutic Approaches in The Patients with Poor Ovarian Response: A Before-After Study. [2022]Advanced age is associated with a decline in the natural oocytes, low oocyte yield, and also increases the assisted reproductive technology (ART) failure rate, and consequently resulted in a pregnancy rate decrease. Platelet-rich plasma (PRP) is one of the proposed therapeutic strategies for women with poor ovarian response (POR). Because of the autologous source of PRP, the lowest risks of disease transmission, immunogenic and allergic reactions have been expected. This study aimed to evaluate the single-dose intraovarian injection of autologous PRP in poor ovarian reserve.
The use of intraovarian injection of autologous platelet rich plasma (PRP) in patients with poor ovarian response and premature ovarian insufficiency. [2022]Intraovarian injection of platelet rich plasma (PRP) is a novel treatment for patients with poor ovarian response (POR) and primary ovarian insufficiency (POI). This article reviews the latest literature on the effect of PRP on markers of ovarian reserve, oocyte and embryo yield, and live birth for these poor prognosis patients.
Transcriptomic profiling analysis of human endometrial stromal cells treated with autologous platelet-rich plasma. [2023]To clarify the mechanisms of intrauterine platelet-rich plasma (PRP) infusion that support embryo implantation in in vitro fertilization treatment.
Effect of intrauterine infusion of autologous platelet-rich plasma in patients with refractory thin endometrium undergoing in vitro fertilization. [2023]Treatment of refractory thin endometrium during IVF is a relatively challenging problem, considering that optimal endometrium thickness is one of the critical factors for successful implantation and pregnancy. Autologous intrauterine platelet-rich plasma (PRP) infusion is an adjuvant therapeutic alternative for enhancing the endometrial thickness (EMT) and echo pattern. It was shown that PRP could expand EMT and improve pregnancy outcomes with its high content of growth factors and cytokines, and its role in the regulation of the immunological interaction between the embryo and the endometrium. The aim of the study is to evaluate the effect of autologous PRP in improving the ongoing pregnancy rate in patients with refractory thin endometrium undergoing IVF.
Does Platelet-Rich Plasma Treatment Increase In Vitro Fertilization (IVF) Success in the Infertile Population? [2023]Platelet-rich plasma (PRP) is obtained by centrifuging the platelet-rich portion of the patient's own blood. The objective of our study is to retrospectively examine the impact of intraovarian PRP injection on infertile women with diminished ovarian reserve, specifically focusing on the oocyte count, oocyte quality, and endometrial thinning.
The efficacy of intrauterine infusion of platelet rich plasma in women undergoing assisted reproduction: a systematic review and meta-analysis. [2023]Platelet-rich plasma (PRP) is an autologous platelet concentration recently used in the reproductive field. Studies had conflicting results regarding its effect on pregnancy outcomes. We aimed to solve the debate on the safety and efficacy of PRP in women undergoing assisted reproduction and assess the influence of covariates on the outcomes of PRP infusion.