Ovarian PRP for Diminished Ovarian Reserve
ConditionDiminished Ovarian Reserve
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-42
SponsorGeneration Next Fertility
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Clinical diagnosis of diminished ovarian reserve
Clinical diagnosis of poor ovarian response
Women age 35-42
Disqualifiers
Clinical diagnosis of premature ovarian failure
Clinical diagnosis of menopause.
Under 35 years of age
Over 42 years of age
Trial design
Design model
Parallel
Treatments tested in this trial
oPRP
Other interventionPrepared 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
Placebo- Serum
Other interventionPatient's serum is injected into ovary instead of PRP as placebo
Treatment groups
230 Participants
are divided into 2 treatment groupsGroup A: oPRP injectionsExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
oPRP changes Ovarian Response and the total Number of oocytes retrieved
Total oocyte yield
Time frame
12 months2
oPRP impacts the Number or Euploid Embryos available for frozen embryo transfers
Available embryos for frozen embryo transfers
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Generation Next Fertility
Lead sponsor
Igenomix
Collaborator
Source ClinicalTrials.gov