Actively Recruiting
Ovarian Platelet-Rich Plasma Injections for Diminished Ovarian Reserve Patients: A Double-Blinded Placebo-Control Trial
Led by Generation Next Fertility · Updated on 2025-02-13
230
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
G
Generation Next Fertility
Lead Sponsor
I
Igenomix
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether ovarian platelet-rich plasma (oPRP) injections can improve in vitro fertilization (IVF) outcomes for women aged 35 to 42 diagnosed with diminished ovarian reserve (DOR), a condition associated with lower pregnancy and live birth chances. This study is a randomized, double-blind, placebo-controlled trial comparing ovarian injections of platelet-rich plasma versus serum placebo in women planning IVF with preimplantation genetic testing for aneuploidy (PGT-A). Participants will undergo a baseline ultrasound and blood tests at menstruation about one month before starting IVF. Depending on follicle counts and hormone levels, patients will follow a natural, mild, or conventional IVF protocol. After ovulation is triggered, patients receive either oPRP or placebo injections under anesthesia within 72 hours. Oocyte retrieval and fertilization procedures follow standard IVF practices, with a second injection administered during retrieval. Monitoring continues between cycles, with two IVF attempts planned unless ineligible. Throughout the trial, patients will undergo routine ultrasounds, blood tests for hormone levels, and monitoring for ovarian cysts. Researchers will assess ovarian response, number of oocytes retrieved, and number of euploid embryos available for frozen embryo transfer over 12 months. The study includes safety and efficacy evaluations, with participants followed through two IVF cycles and their outcomes carefully recorded.
CONDITIONS
Brief Title
Ovarian PRP for Diminished Ovarian Reserve
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of diminished ovarian reserve
- Clinical diagnosis of poor ovarian response
- Women age 35-42
You will not qualify if you...
- Clinical diagnosis of premature ovarian failure
- Clinical diagnosis of menopause
- Under 35 years of age
- Over 42 years of age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 12 months
Participants receive ovarian injections of either platelet-rich plasma (oPRP) or serum (placebo) under anesthesia within 72 hours of ovulation, followed by monitored IVF cycles including oocyte retrievals and injections.
Multiple monitoring visits including baseline ultrasound and blood work, ovulation monitoring, medication start visits with follow-up ultrasounds, oocyte retrieval visits with injections, and post-retrieval monitoring visits
Trial Site Locations
Total: 1 location
1
Generation Next Fertility
New York, New York, United States, 10022
Actively Recruiting
Research Team
A
Alicia Broussard, PhD
J
Jesse Hade, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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