Your session is about to expire
← Back to Search
Other
A-PRP for Primary Ovarian Insufficiency (PRP4POI Trial)
N/A
Waitlist Available
Led By Norbert Gleicher, MD
Research Sponsored by Center for Human Reproduction
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 12 months
Awards & highlights
PRP4POI Trial Summary
This trial is for women with premature ovarian failure, a loss of normal function before age 40. They will receive injections of autologous PRP in one randomly selected ovary.
Who is the study for?
This trial is for women under 40 with primary ovarian insufficiency (early menopause) who have no detectable AMH levels, high FSH levels, and are willing to undergo IVF if needed. Participants must not take NSAIDs like Aspirin a week before treatment, have two ovaries of similar size without large follicles, and provide informed consent.Check my eligibility
What is being tested?
The study tests the effects of injecting autologous PRP (a substance made from the patient's own blood that may help tissue repair) into one ovary of women with premature menopause to see if it can restore ovarian function.See study design
What are the potential side effects?
While specific side effects of A-PRP injections aren't detailed here, common ones could include pain at the injection site, infection risk, bleeding or bruising. Since it uses the patient's own blood components, risks are generally considered low.
PRP4POI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ovarian Follicles
Secondary outcome measures
Clinical Pregnancy
Increase in serum AMH
Retrieval of oocytes in an IVF cycle
PRP4POI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: A-PRPExperimental Treatment1 Intervention
The cortex of selected ovary will be injected with autologous platelet rich plasma.
Group II: ControlActive Control1 Intervention
The contralateral ovary will not be injected.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
A-PRP
2018
N/A
~40
Find a Location
Who is running the clinical trial?
Center for Human ReproductionLead Sponsor
13 Previous Clinical Trials
1,133 Total Patients Enrolled
2 Trials studying Primary Ovarian Insufficiency
215 Patients Enrolled for Primary Ovarian Insufficiency
Norbert Gleicher, MDPrincipal InvestigatorMedical Director
8 Previous Clinical Trials
791 Total Patients Enrolled
3 Trials studying Primary Ovarian Insufficiency
220 Patients Enrolled for Primary Ovarian Insufficiency
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have premature ovarian failure due to a genetic condition like Turner's Syndrome.I have a major mental health disorder.Both of my ovaries are about the same size.I haven't taken Aspirin or NSAIDs like Motrin for about a week.My blood pressure and heart rate are not stable.I have a very low platelet count.I am open to having fertility treatments, including IVF, if they work.I have a blood disease.Low levels of fibrinogen in the blood.I do not have a current drug or alcohol problem.I have an autoimmune disease like lupus.I am on blood thinners.I have a cancer affecting my bones or blood.My genetic test shows a normal chromosome arrangement.Your Anti-Müllerian hormone (AMH) cannot be detected in your blood.Your FSH level is higher than 30.I do not have any ongoing infections.Your ovaries do not show any follicles larger than 4mm.I currently have sepsis.I am 40 or younger with early menopause confirmed by tests.I am 40 or younger with diagnosed early menopause.My two ovaries are about the same size.
Research Study Groups:
This trial has the following groups:- Group 1: A-PRP
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Primary Ovarian Insufficiency Patient Testimony for trial: Trial Name: NCT03542708 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Nebraska
New Jersey
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
What site did they apply to?
Center For Human Reproduction
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I dont give up my dream.
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
How Long do screening vesits take?
PatientReceived 2+ prior treatments
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- Center For Human Reproduction: < 48 hours
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger