Ovarian PRP Injections for Improved Embryo Quality Using Embryo Quality Score

NCT ID: NCT07020546

Last Updated: 2025-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-08

Study Completion Date

2026-08-30

Brief Summary

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

Detailed Description

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. 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.

Conditions

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Infertility Poor Ovarian Reserve Embryo Growth Disorder in Vitro Fertilization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A NON-RANDOMIZED PROSPECTIVE SELF-CONTROLLED INTERVENTIONAL STUDY
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Ovarian Platelet-rich plasma (PRP) injections

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

47 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Generation Next Fertility

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jesse Hade, MD

Role: PRINCIPAL_INVESTIGATOR

Generation Next Fertility

Locations

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Generation Next Fertility

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alicia L Broussard, PhD

Role: CONTACT

3174456958

Jesse Hade, MD

Role: CONTACT

2126410906

Facility Contacts

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Alicia L Broussard, PhD

Role: primary

212-641-0906

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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IORG0010499-012025

Identifier Type: -

Identifier Source: org_study_id

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