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Platelet Rich Plasma
PRP Therapy for Infertility (PIER Trial)
N/A
Recruiting
Research Sponsored by Reproductive Medicine Associates of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 9 weeks gestational age
Summary
This trial will test whether a PRP infusion into the uterus can help infertile women with thin endometrium conceive via IVF.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include discomfort at the infusion site, bleeding, infection risk from the procedure itself, and possible allergic reactions to PRP components. However, specific side effects will depend on individual patient responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during the proliferative phase of the frozen embryo transfer cycle
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the proliferative phase of the frozen embryo transfer cycle
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Endometrial Thickness during frozen embryo transfer
Secondary study objectives
Sustained implantation rate
Trial Design
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
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Who is running the clinical trial?
Reproductive Medicine Associates of New JerseyLead Sponsor
53 Previous Clinical Trials
37,872 Total Patients Enrolled
31 Trials studying Infertility
19,331 Patients Enrolled for Infertility
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had at least 2 failed embryo transfers without a successful pregnancy.My embryo for transfer was created using sperm obtained through surgery due to non-obstructive azoospermia.I will stop any additional cancer growth treatments when I join the trial.I am willing and able to give written consent to participate in the study.I have had recurring fluid in my uterus.I use blood thinners and cannot receive plasma infusions.I have had blood clots in the past.My endometrial lining was 6 mm or less during past embryo transfers.I have a condition that makes my blood clot more than normal.I have fibroids or need surgery for uterine issues.I have a fallopian tube condition not planned for surgery before joining the study.I have a uterine abnormality, but it's not an arcuate uterus.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Control Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Infertility Patient Testimony for trial: Trial Name: NCT05538338 — N/A