Ovarian PRP Injections for Improved Embryo Quality Using Embryo Quality Score

July 8, 2025 updated by: Generation Next Fertility

Ovarian Platelet-Rich Plasma (oPRP) Injections Improvement In IVF Patients Based On Time-Lapse Incubator Culture for Automated Tracking and AI for Embryo Quality Assessment : A Non-Randomized Propsective Self-Controlled Interventional Study

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

. oPRP Treatment & Second IVF Cycle (Study Cycle)

  • Following the first IVF cycle, patients will undergo their first oPRP injection:

    • Timing: 1-2 weeks after the onset of the next menstrual cycle.
    • Procedure: Under IV sedation, a patient's autologous PRP will be prepared and injected directly into both ovaries under transvaginal ultrasound guidance.

  • Second IVF Cycle (oPRP Study Cycle)

    • The same ovarian stimulation protocol will be used for consistency.
    • A second oPRP injection will be performed on stimulation days 2-5 to enhance folliculogenesis.
    • Ovulation will be triggered at the same follicular size thresholds, and oocyte retrieval will follow identical protocols.
    • Fertilization methodology will be identical to the first cycle unless no fertilization is identified in the first cycle.
    • Embryo Development Analysis: Up to 15 embryos will be cultured in the AI incubator, where time-lapse imaging will track their morphokinetics, and AI-based analysis will assess embryo viability and implantation potential.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Embryo Development Before and After Ovarian PRP Using Time-Lapse AI Embryo Quality Score
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blastocyst formation and embryo quality
Time Frame: 1 year
The number of high quality embryos that are created per cycle
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live birth rate per transfer
Time Frame: 2 years
The number of live births following embryo transfer
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Generation Next Fertility

Investigators

  • Principal Investigator: Jesse Hade, MD, Generation Next Fertility

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

May 13, 2025

First Submitted That Met QC Criteria

June 10, 2025

First Posted (Actual)

June 13, 2025

Study Record Updates

Last Update Posted (Actual)

July 9, 2025

Last Update Submitted That Met QC Criteria

July 8, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IORG0010499-012025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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