Ovarian PRP Injections for Improved Embryo Quality Using Embryo Quality Score

NCT07020546 | Recruiting DMC

• 1 other identifier: IORG0010499-012025
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Patients will have ovarian PRP treatments and embryo development will be observed using time-lapse imaging and AI software.

Conditions

Infertility; Poor Ovarian Reserve; Embryo Growth Disorder; in Vitro Fertilization

Outcome Measures

Primary Outcomes (1)

• Blastocyst formation and embryo quality

  The number of high quality embryos that are created per cycle

  1 year

Secondary Outcomes (1)

• Live birth rate per transfer

  2 years

Study Arms (1)

Embryo Development Before and After Ovarian PRP Using Time-Lapse AI Embryo Quality Score

EXPERIMENTAL

Patients will undergo two IVF cycles. The first cycle will be before ovarian PRP treatment and the second will be after. The embryo development measured by data gathered in time-lapse imaging and AI software will be used to determine differences between the groups within the same patient

Procedure: Ovarian Platelet-rich plasma (PRP) injections

Interventions

Ovarian Platelet-rich plasma (PRP) injections PROCEDURE

This is a procedure that our patients receive at our clinic. We want to use the AI software to evaluate embryo development before and after treatment to see if there is a difference in embryo quality after PRP treatment within the same patient.

Embryo Development Before and After Ovarian PRP Using Time-Lapse AI Embryo Quality Score

Eligibility Criteria

• Age: 18 Years - 47 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• No none contraindications to IVF or PRP treatment
• Adequate ovarian reserves and AMH level
• Willingness to undergo two IVF cycles and oPRP treatment

You may not qualify if:

• Anovulation due to menopause or perimenopause
• Any health conditions that are contraindicated for IVF or oPRP treatment

Sponsors & Collaborators

• Generation Next Fertility: lead

Study Sites (1)

Generation Next Fertility

New York, New York, 10022, United States

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Injections

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jesse Hade, MD

  Generation Next Fertility

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia L Broussard, PhD

CONTACT

3174456958; a.broussard@generationnextfertility.com

Jesse Hade, MD

CONTACT

2126410906; j.hade@generationnextfertility.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A NON-RANDOMIZED PROSPECTIVE SELF-CONTROLLED INTERVENTIONAL STUDY

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 13, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)