Recruiting

PRP

Sponsor:

Generation Next Fertility

Code:

NCT05790655

Conditions

Diminished Ovarian Reserve

Eligibility Criteria

Sex: Female

Age: 35 - 42

Healthy Volunteers: Accepted

Interventions

oPRP

Placebo- Serum

Study Details

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.

Conditions

Diminished Ovarian Reserve

Study ID

NCT05790655

Start date

Oct 7, 2023

Status verified date

Feb, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Mar 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35 - 42

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Clinical diagnosis of diminished ovarian reserve
  • Clinical diagnosis of poor ovarian response
  • Women age 35-42

Exclusion Criteria:

  • Clinical diagnosis of premature ovarian failure
  • Clinical diagnosis of menopause.
  • Under 35 years of age
  • Over 42 years of age

Study Design

Enrollment

230 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: oPRP injections

Patients own prepared PRP will be injected into each ovary

placebo comparator: Placebo

Patient's serum will be injected into the ovary (not rich with platelets)

Interventions

oPRP

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

Placebo- Serum

Patient's serum is injected into ovary instead of PRP as placebo

Primary outcome measure

  • oPRP changes Ovarian Response and the total Number of oocytes retrieved [ Time Frame: 12 months ]
  • oPRP impacts the Number or Euploid Embryos available for frozen embryo transfers [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Alicia Broussard, PhD

3174456958a.broussard@generationnextfertility.com

Jesse Hade, MD

2126410906j.hade@generationnextfertility.com

Locations

Generation Next Fertility

Recruiting

New York, New York, United States, 10022

Contacts

Jesse Hade, MD

212-641-0906j.hade@generationnextfertility.com

Alicia Broussard, PhD

2126410906a.broussard@generationnextfertility.com

More Information

Sponsor

Generation Next Fertility

Last update posted

Feb 13, 2025

Last verified

Feb, 2025

Keywords

  • Ovarian Platelet Rich Plasma
  • DOR
  • Ovarian PRP
  • IVF
  • PRP
  • PGT-A
  • ICSI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Generation Next Fertility on 2025-02-13.