Ovarian PRP for Diminished Ovarian Reserve
oPRP
Ovarian Platelet-Rich Plasma Injections for Diminished Ovarian Reserve Patients: A Double-Blinded Placebo-Control Trial
1 other identifier
interventional
230
1 country
1
Brief Summary
This prospective double-blinded randomized placebo control study aims to determine if In Vitro Fertilization (IVF) outcomes are improved by ovarian platelet-rich plasma injections (oPRP) for women diagnosed with diminished ovarian reserve (DOR). Women with DOR notoriously have the lowest chance of pregnancy and live birth compared to age-matched peers with a normal or robust ovarian reserve.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2023
CompletedFirst Posted
Study publicly available on registry
March 30, 2023
CompletedStudy Start
First participant enrolled
October 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFebruary 13, 2025
February 1, 2025
1.4 years
March 6, 2023
February 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
oPRP changes Ovarian Response and the total Number of oocytes retrieved
Total oocyte yield
12 months
oPRP impacts the Number or Euploid Embryos available for frozen embryo transfers
Available embryos for frozen embryo transfers
12 months
Study Arms (2)
oPRP injections
EXPERIMENTALPatients own prepared PRP will be injected into each ovary
Placebo
PLACEBO COMPARATORPatient's serum will be injected into the ovary (not rich with platelets)
Interventions
Prepared sample from patient's own blood collected and processed. Either PRP or serum is injected into the patient's ovary. All other care is standard for the IVF process
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of diminished ovarian reserve
- Clinical diagnosis of poor ovarian response
- Women age 35-42
You may not qualify if:
- Clinical diagnosis of premature ovarian failure
- Clinical diagnosis of menopause.
- Under 35 years of age
- Over 42 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Generation Next Fertilitylead
- Igenomixcollaborator
Study Sites (1)
Generation Next Fertility
New York, New York, 10022, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Jesse Hade, MD
Generation Next Fertility
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The patient and PI will not know which arm the patient is in. This will not be unblinded until study completion
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2023
First Posted
March 30, 2023
Study Start
October 7, 2023
Primary Completion
March 1, 2025
Study Completion
December 31, 2025
Last Updated
February 13, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- April 2023 to April 2024
- Access Criteria
- Protocol may be shared with other research bodies upon request for collaboration
Collaboration to share protocol may be requested with PI