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
Phase: NA
Conditions: Infertility, Poor Ovarian Reserve, Embryo Growth Disorder, in Vitro Fertilization
Sponsor: Generation Next Fertility

GNFIRB#V12025
June 1, 2025
Title: OVARIAN PLATELET-RICH PLASMA (oPRP) INJECTIONS FOR IMPROVEMENT IN IVF
PATIENTS BASED ON TIME-LAPSE INCUBATOR CULTURE FOR AUTOMATED TRACKING AND
AI FOR EMBRYO QUALITY ASSESSMENT: A NON-RANDOMIZED PROSPECTIVE
SELF-CONTROLLED INTERVENTIONAL STUDY
Sponsor: Generation Next Fertility
Investigators:
Jesse J. Hade MD, Janelle Luk MD, Edward Nejat MD, Serin Seckin MD, Alicia Broussard PhD
115 East 57th Street, 11th Floor
New York, NY 10022
Phone: (212) 641-0906
Fax: (212) 641-0522
E-Mail:
Proposal Voted on and Approved by Committee on 3/24/2025
10.0
Title of Policy: Research & Ethical Advisory Board
Policy Number: GNF0103
Date of Initiation: 01/01/2021
Last Revision/Update: 01/01/2021
Policy Author: Vitaly A. Kushnir, MD
All research at Generation Next Fertility (GNF) is performed under the supervision of
Institutional Review Board (IRB), which is to include fair representation of the community,
infertility patients, GNF staff and researchers.
The IRB is to be headed by a Chair, who preferably should not be an employee of GNF.
The IRB Chair may appoint a sub-committee to help in the conduct of his/her
responsibilities.

IRB meetings are to be called per need and may be held by teleconference.
A current listing of members is Vitaly A. Kushnir, MD, Joshua Johnson, MD, Michael Heard,
MD
Because research represents such an integral part of GNF, the initial informed consent
documents patients sign upon initial visit to GNF, shall inform them that all medical record
and discarded biological specimens at GNF may be utilized for medical research and/or
quality control purposes. Moreover, patients shall be informed in these documents that no
further consent may be required from them for use of their medical records or discarded
biological specimens in research and/or quality control activities, as long as confidentiality
is maintained and the identity of patients remains protected.
No research shall be performed on medical records or discarded biological specimens,
unless consent, containing such language, was signed by the patient.
A. DEFINITIONS
The IRB represent an oversight body, constituted of GNF employees and external board
members, charged with overseeing certain activities at GNF. Activities under IRB
oversight, include all activities relating to the performance of assisted reproduction (i.e., in
vitro fertilization and related procedures) and all research activities at GNF.
Moreover, the IRB shall serve as GNF’s human subject and ethical advisory board, which
shall be consulted by GNF staff whenever ethical issues arise, which are not clearly
defined by the standard of daily clinical care, practiced at GNF and in the community.
IRB members are subject to annual appointments and re-appointments by the ART
Director or designee of GNF.
There shall be no payments made to IRB members, though they may receive
reimbursement for expenses incurred in fulfillment of their responsibilities as IRB
members.
While IRB members are subject to appointment by the ART Director or designee of GNF,
the IRB shall be representative of GNF as well as general community interests. Therefore,
the position of Chair shall be filled by an external (non-GNF employed) individual, who
shall be either a physician or scientist and, preferably, a majority of board members shall
be representative of community interests (i.e., be external board members). The ART
Director or designee of GNF shall serve as Vice-Chair of the IRB.
The IRB shall in all of its functions report directly to the Board of Directors of GNF. While
the ART Director or designee of GNF appoints IRB members, involuntary dismissal of IRB
members shall only be possible by decision of the Board of Directors of GNF.
Since members of the IRB may have access to confidential patient data, they shall be
obliged to sign a confidentiality agreement with GNF, which mandates that all patient
information they become privy to be held in confidence and not be communicated to any
third parties.
B. MISSION STATEMENT:
The mission of GNF’s IRB is to assure that all clinical and research activities, conducted at
GNF, comply with basic human rights, as defined by the revised Declaration of Helsinki,
passed in October 2000 at the 52nd World Medical Association General Assembly in
Edinburgh, Scottland, UK and that any form of animal experimentation, if conducted at

GNF, follows internationally accepted guidelines for the protection of animals in such
research.
C. PROCESS IMPLEMENTATION:
All application forms, required for submission to the IRB, shall be electronically available
from the business offices of GNF.
The IRB shall meet per need, as defined by Chair or Vice-Chair. A quorum is defined as the
presence of at least one third of appointed members.
Meetings of the IRB shall follow rules and shall be documented by minutes, to be signed by
Chair or Vice-Chair.
Agenda and items, submitted for review to any IRB meeting, shall be distributed to all IRB
members at least five (5) working days in advance of such meeting to allow for proper
familiarization with materials.
Each research project, submitted for review to the IRB, shall be numbered with date of IRB
meeting when first reviewed and consecutive project number of that meeting (i.e., for
example 8/21/19-1, denoting the first project reviewed by the IRB on 8/21/19).
The principal investigator (PI) for each research project shall be principally responsible for
annual progress and/or completion reports.
GNF’s manager shall maintain all IRB files and shall inform Chair of IRB in timely fashion of
annual and/or completion reports that become due.
Items submitted for review by the IRB may be of the following nature:
(i) INFORMAL REPORT:
Purpose: Information of IRB members only; no decision
expected/required.
Examples: IVF-related outcome reports, or informal
updates on previously approved research projects.
(ii) INQUIRY:
Purpose: Question to IRB;
Examples: Ethical concerns or introduction of ethically
controversial new clinical technique in IVF.
(iii) NEW RESEARCH PROJECT:
Purpose: Review and approval;
(iv) EXPEDITED REVIEW:
Purpose: Expedited review and approval by Chair alone.
(v) RE-APPROVAL/TERMINATION OF RESEARCH PROJECT

Purpose: Re-approval or termination;
Requests for IRB involvement in regards to (i), (ii) and (v) shall take the format of a formal
letter “to the IRB”.
Requests for IRB involvement in regards to (iii) shall take the format of a formal research
project review, using standard GNF IRB format (Appendix), including a covering letter by
the principal investigator (PI) “to the IRB,” requesting review and approval of the proposed
project.
Requests for IRB involvement in regards to (iv) shall take the format of a formal letter from
the PI “to the IRB,” requesting expedited review and approval of a project by the Chair.
Such a letter shall contain: (1) a description of reason(s) why expedited (in place of full
IRB) review appears appropriate (see below); (2) documentation by supporting documents
(i.e., prior IRB approvals of project at other institution, etc).
CRITERIA FOR EXPEDITED REVIEW
All research shall be reviewed by the full IRB unless criteria for expedited review of a
project are met, in which case only the Chair, under his full discretion, can choose to grant
expedited review and approval. The Chair, at own discretion, can at any moment return
such expedited review to review by the complete IRB.
In case the Chair grants expedited review and approves a project, he shall issue a formal
written approval letter for the project, which shall otherwise administratively be handled
like any other research project, reviewed by the IRB, with the date of the decision letter
being considered the date of IRB review.
Criteria for expedited review exist if:
(i) A research project has previously undergone detailed review and approval at
another formal IRB and such process is documented.
(ii) GNF joins a research project, already elsewhere underway, and at that other
institution reviewed and approved by a formal IRB.
(iii) Another institutions wishes to join a GNF project, already previously
reviewed and approved by GNF’s IRB.
(iv) The complete IRB has granted the Chair specific authority.
APPENDIX
SUBMISSION PACKAGE, REQUESTING REVIEW
AND CONSIDERATION FOR APPROVAL OF
RESEARCH PROJECT BY GNF’s IRB
[ ] EXPEDITED REVIEW
New Research Project
[x ] COMPLETE APPLICATION
RESEARCH SUBJECT OVARIAN PLATELET-RICH PLASMA INJECTIONS AND AI EMBRYO
ASSESSMENT INFORMATION & CONSENT FORM
Title: OVARIAN PLATELET-RICH PLASMA (oPRP) INJECTIONS FOR IMPROVEMENT IN IVF
PATIENTS BASED ON TIME-LAPSE INCUBATOR CULTURE FOR AUTOMATED TRACKING AND
AI FOR EMBRYO QUALITY ASSESSMENT: A NON-RANDOMIZED PROSPECTIVE
SELF-CONTROLLED INTERVENTIONAL STUDY

Sponsor: Generation Next Fertility
Investigators:
Jesse J. Hade MD, Janelle Luk MD, Edward Nejat MD, Serin Seckin MD, Alicia Broussard PhD
115 East 57th Street, 11th Floor
New York, NY 10022
Phone: (212) 641-0906
Fax: (212) 641-0522
E-Mail:
IVF AND PRP HISTORICAL CONTEXT
In vitro fertilization (IVF) was first successfully employed in a human in 1978 during an
unstimulated natural cycle, leading to the birth of Louise Brown, the first IVF baby. Due to
the limited success of natural IVF cycles, gonadotropins were introduced as a means to
stimulate the growth and maturation of multiple antral follicles before oocyte retrieval,
significantly improving the efficiency of IVF treatments. Over the years, controlled ovarian
stimulation has enhanced the success of IVF by increasing the number of mature oocytes
retrieved, thereby improving fertilization rates and the likelihood of achieving pregnancy
and live birth.
Autologous platelet-rich plasma (PRP) was introduced as a transfusion product by
hematologists in the 1970s for the treatment of thrombocytopenia. PRP is defined as
plasma with a platelet concentration above that of peripheral blood and has since been
widely adopted in various medical fields, including orthopedics, cardiothoracic surgery,
plastic surgery, dermatology, dentistry, and diabetic wound healing, due to its
regenerative properties.
The first recorded ovarian PRP (oPRP) procedure was performed in 2018, demonstrating
improvements in ovarian function, folliculogenesis, and ovulation induction, particularly in
patients with diminished ovarian reserve. Preliminary studies have suggested that oPRP
injections may enhance ovarian reserve markers, increase the number of retrieved mature
oocytes, and improve embryo quality, leading to better IVF outcomes. The mechanism
behind oPRP's efficacy is believed to involve growth factors such as platelet-derived
growth factor (PDGF), transforming growth factor-beta (TGF-β), and vascular endothelial
growth factor (VEGF), which contribute to tissue regeneration and angiogenesis within the
ovarian microenvironment.
The potential benefits of PRP for ovarian and endometrial rejuvenation have been
postulated based on data extrapolated from prior medical research. However, despite
promising initial findings, most of the information demonstrating the benefit of PRP on
ovarian reserve, oocyte quality, and embryo development remains limited to anecdotal
evidence and small-scale studies. Large-scale, well-controlled clinical trials are needed to
establish definitive efficacy and safety in this domain.
PURPOSE OF THIS RESEARCH
This is a non-randomized prospective self-controlled interventional study evaluating the
impact of oPRP injections on embryo quality in patients undergoing two IVF cycles.
Participants will undergo two IVF cycles at Generation Next Fertility.
The first cycle will serve as the control (no oPRP treatment), while the second study cycle
will incorporate oPRP injections.
Oocytes retrieved will undergo fertilization using one of the following methods:
Conventional Insemination

Intracytoplasmic sperm injection (ICSI)
ICSI with Zymot
ICSI with Zymot and Physiological ICSI (PICSI)
Patients may opt for Preimplantation Genetic Testing for Aneuploidy (PGT-A) through
Genomic Prediction LLC's LifeView™ platform, which utilizes single nucleotide
polymorphism (SNP) technology to enhance accuracy in detecting chromosomal
abnormalities.
All embryos from both IVF cycles will be cultured in a time-lapse incubators for automated
tracking and assessment.
Embryo quality will be measured by an AI software used in conjunction with the time-lapse
incubators.
This study aims to evaluate whether ovarian platelet-rich plasma (oPRP) injections improve
embryo quality in In Vitro Fertilization (IVF) cycles. Patients will undergo two IVF cycles:
First cycle (Control cycle): A standard IVF cycle with individualized ovarian stimulation
protocols based on AMH, AFC and patient history and prior IVF outcomes when applicable.
Second cycle (Study cycle): Includes oPRP injections, administered:
1-2 weeks after the onset of menses following the first IVF cycle.
A second injection between stimulation days 2-5 of the second IVF cycle.
The protocol of the second IVF cycle will be again based on the same criteria as the first
IVF cycle. Embryos from both cycles will be monitored using a time-lapse incubator in
conjunction with an AI software to analyze embryo development and assess Embryo
Quality (EQ) scores. The study will determine if oPRP improves embryo quality and
implantation potential. Each embryo will be given an EQ (embryo quality) score based on
the morphokinetics of the embryos during the incubation period. The Embryo Quality (EQ)
Score, generated through AI analysis, will be used to assess whether oPRP improves
embryo development, viability, and implantation potential. No clinical decision will be
made based upon the resulting Embryo Quality (EQ) Score. The time-lapse based AI
software for embryo assessment is an investigational device, which means that it is not
approved by the Food and Drug Administration (FDA)
STUDY PROTOCOL
1. Baseline Evaluation & Enrollment
All participants will undergo a baseline ultrasound and hormonal blood workup at the start
of their menstrual cycle, approximately one month or more prior to initiating the first IVF
cycle. This baseline assessment will include:
Ultrasound to determine antral follicle count (AFC) and assess ovarian morphology.
Hormonal testing including Anti-Müllerian Hormone (AMH), Follicle-Stimulating Hormone
(FSH), Luteinizing Hormone (LH), Estradiol (E2), Progesterone (P4), Thyroid Stimulating
Hormone (TSH), Prolactin (PRL) and Beta-Human Chorionic Gonadotropin (β-hCG).
Routine infectious disease screening in compliance with IVF laboratory standards for both
the patient and any male partner.
Genetic Carrier screening through Horizon™ advanced carrier screening test by Natera,
Inc. will be offered to all patient’s and their partners
Semen Analysis for all male partners to determine if a male factor infertility is present.
Patients will then proceed with their first IVF cycle under a standardized ovarian

stimulation protocol based on their ovarian reserve and history of previous IVF response
when applicable.
2. First IVF Cycle (Control)
The first IVF cycle will serve as a control cycle, conducted without oPRP injections.
The ovarian stimulation protocol (natural, mild, or conventional) will be determined based
on AFC and hormonal profile.
Once the lead follicle reaches the appropriate size (≥18 mm), ovulation will be induced
using 10,000 IU of human chorionic gonadotropin (hCG) or 250 mcg Ovidrel®, or 80-100
IU of Leuprolide acetate or a combination of the above administered approximately 35.5
hours prior to retrieval.
Oocyte retrieval will be performed under deep intravenous (IV) sedation by a
board-certified anesthesiologist, using transvaginal ultrasound guidance.
Fertilization Method Options:
Conventional Insemination
Intracytoplasmic sperm injection (ICSI)
ICSI + Zymot sperm selection
ICSI + Zymot + Physiological ICSI (PICSI)
With or without PGT-A using SNP-based LifeView® technology from Genomic Prediction
LLC.
Up to 15 embryos will be cultured in the time-lapse incubator, which in conjunction with AI,
provides an automated embryo quality score based on morphokinetic parameters. The
resulting AI Score will not be used to guide any clinical decisions.
All embryos reaching the blastocyst stage will be biopsied (if PGT-A is elected), vitrified,
and stored for potential future embryo transfer.
3. 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 a time-lapse
incubator, which in conjunction with AI, provides an automated embryo quality score
based on morphokinetic parameters. The resulting AI Score will not be used to guide any
clinical decisions.
4. Data Collection & Outcome Measures
Primary vs. Secondary Outcome Measures

Primary Outcome Measure:
Improvement in blastocyst formation rate following oPRP treatments, as assessed by the
use of a time-lapse incubator in conjunction with AI.
Secondary Outcome Measures:
Improvement in embryo quality based on Morphokinetics using the AI score from
time-lapse videography.
Changes in ovarian reserve markers (AMH, AFC, FSH, E2) post-oPRP.
Increase in the number of mature (MII) oocytes retrieved in the second IVF cycle.
Increase in 2 PN embryos formed
Increase in Day 3 embryos formed with 6 cells or more
Increase in Blastocysts formed
Increase in High Quality blastocysts formed (3BB or better)
Increase in Euploid embryos based on PGT-A analysis when available
Clinical pregnancy rate per embryo transfer.
Live birth rate following embryo transfer.
MONITORING & SAFETY
Patients will be closely monitored throughout both IVF cycles to ensure optimal response
and minimize risks.
Bloodwork and ultrasound assessments will be conducted regularly to track follicular
development, endometrial thickness, and hormonal response.
Any adverse events, including ovarian hyperstimulation syndrome (OHSS), infection, or
complications related to IVF or oPRP injections, will be documented and reported.
Safety data from over 940 oPRP injections performed to date at GNF since July 2021
indicate no major complications requiring hospitalization, blood or blood product
transfusion, surgery, or other interventional procedures.
The most commonly reported side effect from the ovarian PRP procedure was transient
pain at the ovarian injection site, lasting a maximum of four days, all of which resolved
with expectant management.
Inclusion & Exclusion Criteria
Inclusion Criteria:
Patients age 18 to 47 who are eligible for both In Vitro Fertilization (IVF) and ovarian
Platelet-Rich Plasma (oPRP) injections.
No known contraindications to IVF or oPRP as outlined in the exclusion criteria.
Willing to undergo two consecutive IVF cycles, with the first cycle serving as a control and
the second cycle including oPRP injections.
Adequate ovarian reserve based on baseline antral follicle count (AFC) and anti-Müllerian
hormone (AMH) levels.
Exclusion Criteria:
Patients will be excluded from participation if they meet any of the following conditions:
Anovulation due to perimenopause or menopause, as determined by clinical evaluation
and laboratory testing
Ovarian accessibility issues, including:

Ovaries not accessible via transvaginal ultrasound
Large unresolved ovarian cysts
History of ovarian abscess or pelvic infection
Any medical condition where pregnancy is contraindicated, including but not limited to:
Severe cardiovascular disease
Uncontrolled hypertension or diabetes
Renal or hepatic insufficiency
History of malignancies, including:
Breast, gynecologic, hematologic (leukemia, lymphoma), or other cancers
Borderline ovarian tumors
Hematologic disorders, including:
Anemia (low hemoglobin/hematocrit levels)
Sickle cell disease, beta-thalassemia, or alpha-thalassemia
Polycythemia (abnormal increase in red blood cells)
Thrombocytopenia (low platelet count) or any platelet dysfunction disorder
Hypercoagulable conditions, such as:
Deep vein thrombosis (DVT)
Pulmonary embolism (PE)
History of stroke or transient ischemic attack (TIA)
Uncontrolled or poorly managed autoimmune diseases, including:
Systemic lupus erythematosus (SLE)
Sjögren’s syndrome
Uncontrolled diabetes mellitus
Severe uncontrolled thyroid dysfunction (hypothyroidism or hyperthyroidism)
Use of medications contraindicated for IVF or oPRP, including:
NSAIDs (Non-Steroidal Anti-Inflammatory Drugs)
Anticoagulants or blood thinners (oral or injectable, e.g., Lovenox, Heparin, Warfarin)
Chronic corticosteroid use
Substance use that may negatively impact IVF or oPRP response, including:
Excessive alcohol consumption
Recreational drug use
Prior oPRP treatment within the past 6 months
Patients unwilling or unable to complete two consecutive IVF cycles
Patients under the age of 18 or over the age 47
NUMBER OF SUBJECTS / LENGTH OF PARTICIPATION
This study employs a prospective non-randomized self-controlled design, where each
patient serves as their own control by undergoing two IVF cycles—one without oPRP
(control cycle) and one following two oPRP treatments (study cycle). While this design
reduces inter-patient variability, we acknowledge the potential for time-dependent
confounders and variations in ovarian response.
Baseline Blastocyst Formation Rate per Oocyte Retrieved: 25% (based on retrospective

clinical data).
Expected Improvement of Blastocyst formation rate with oPRP: 35% (a 10% absolute
increase, representing a 40% relative improvement).
Statistical Parameters:
Power: 80%
Alpha (Significance Level): 0.05
Study Design: Self-controlled (paired analysis)
Based on these parameters, we aim to detect a minimum detectable effect size of
approximately a 10% absolute increase in blastocyst formation rate (from 25% to 35%). To
achieve this, a total sample size of 180 patients is required. This calculation accounts for
the paired nature of the study design and the expected discordant proportions between
the control and study cycles.
To maintain statistical robustness, we have chosen a sample size of 180 patients, which
includes an estimated 10-15% dropout rate for cycle cancellations or variability in ovarian
response. An interim analysis will be conducted at 50% enrollment to validate initial
assumptions regarding oPRP’s impact on blastocyst formation.
This study will also consider an external control group of patients undergoing two IVF
cycles without oPRP to further validate findings and minimize bias.
BENEFITS
Participation in this study may offer personal reproductive benefits, as the use of ovarian
platelet-rich plasma (oPRP) injections has been associated with enhanced ovarian function,
improved folliculogenesis, and increased oocyte quality in preliminary studies. These
improvements may, in turn, increase the number of mature oocytes retrieved, improve
embryo development, and enhance implantation potential, potentially improving the
likelihood of pregnancy.
A key component of this study is the use of a time-lapse incubator in conjunction with AI,
which will provide real-time, continuous monitoring of embryo development. This
advanced imaging technology allows for detailed morphokinetic analysis of embryos. By
using this cutting-edge incubator, we aim to further optimize embryo selection, reduce
subjectivity in grading, and potentially improve IVF outcomes.
While these potential benefits exist, it is important to acknowledge that pregnancy cannot
be guaranteed, and some or all participants may not experience any improvement in their
fertility outcomes. However, if oPRP proves to be beneficial, this research may have
far-reaching implications for reproductive medicine, offering an innovative and less
invasive alternative for women with poor ovarian response or diminished ovarian function.
Additionally, this study may contribute to advancing fertility treatments, helping future
patients by providing more data on the efficacy of oPRP in IVF and refining embryo quality
assessment using AI-driven technology. By participating, you will be contributing to
cutting-edge reproductive research that could enhance success rates and reduce the
overall burden of fertility treatments in the future.
Compensation for Participation
The primary goal of this study is to assess the potential benefits of ovarian platelet-rich

plasma (oPRP) injections in improving IVF outcomes. Participants in this study will receive
a substantial reduction in the cost of specific services provided by Generation Next
Fertility (GNF), including:
Two discounted IVF cycles, inclusive of ovarian follicular monitoring and oocyte retrieval
for patient’s not using their health insurance coverage for this treatment.
Two free oPRP injections (both the initial and second treatment)
Free Intracytoplasmic Sperm Injection (ICSI)
Discounted Zymot and PICSI sperm selection methods (if chosen)
Discounted Embryo biopsy fee for Preimplantation Genetic Testing for Aneuploidy,
monogenetic diseases or structural rearangements (PGT-A/M/SR) (if chosen)
Free embryo cryopreservation and storage for up to 6 months
Free use of the time-lapse incubator with AI for continuous embryo monitoring and
evaluation
Sources of Funding
This research study is fully funded by Generation Next Fertility, PLLC. No external funding
sources or third-party financial sponsorships are involved.
Patient Financial Responsibility
Patients will be responsible for:
The full cost of PGT-A/M/SR tissue analysis if they choose to proceed with genetic testing
of their embryos
Any additional embryo storage fees beyond the six-month complimentary period
All medical expenses related to pregnancy beyond the first pregnancy test
Any non-study-related procedures or treatments
The full cost of ovarian stimulation medications required for both IVF cycles
The full cost of the frozen embryo transfer (FET) cycle if an embryo is cryopreserved
Insurance Coverage Considerations
Patients using insurance coverage for IVF treatments at Generation Next Fertility will
receive a discount on all out-of-pocket expenses for procedures not covered by insurance.
However, this discount does not apply to medication costs, PGT-A/M/SR embryo analysis,
anesthesia-related services, or the FET cycle, which remain the patient’s financial
responsibility.
Important Considerations
No monetary compensation will be provided for participation in this study.
Participation in the study does not guarantee pregnancy or improved fertility outcomes.
The cost reduction only applies to services rendered by Generation Next Fertility and does
not cover external laboratory fees, additional medical costs, medications, prolonged
embryo storage fees beyond 6 months, or the cost of the frozen embryo transfer cycle.
SUBMISSION CHECK LIST FOR COMPLETE APPLICATIONS
_______ Only complete applications submitted at least 5 business days before an
IRB meeting will be considered.

_______ Submit application electronically to IRB Chair
_______ Date of submission is: ___________
_______ Application complete; The following was addressed:
I. General Aspects
II. Study Design
III. Informed Consent Information
IV. Project Summary
V. Funding
VI. Principal Investigator Assurance
Appendix
INSTITUTIONAL REVIEW BOARD OF THE GNF CENTER FOR
ADVANCED FERTILITY
APPLICATION TO CONDUCT A RESEARCH PROJECT
I. GENERAL ASPECTS: This COMPLETE application for review by the IRB of GNF applies only
to projects initiated at GNF or in collaboration with GNF. Projects initially initiated at other
medical institutions, which GNF staff wishes to join in a collaborative effort, shall be first
reviewed and approved by an outside IRB, responsible for project reviews at the
originating medical institution. Once approval of the project has been obtained by that
IRB, an EXPEDITED REVIEW by the Chair of the GNF IRB can be requested. In case such an
expedited review is requested, only Section I of this application (General Aspects) is to be
completed and all relevant materials from the other institution’s IRB review and approval
are to be attached.
This is a request for a [x ] COMPLETE REVIEW [ ] EXPEDITED REVIEW
Title of Proposal: RESEARCH SUBJECT OVARIAN PLATELET-RICH PLASMA
AND TIME-LAPSE INCUBATOR WITH AI INFORMATION & CONSENT FORM
Principal Investigator: Jesse Hade, MD
The Principal Investigator (PI) is the principally responsible individual to the IRB for
submission of a complete
application and the content as well as veracity of this application. He/she is also the
principally responsible
individual for the proper conduct of any IRB-approved research project.
Co-Investigators: Janelle Luk, MD, Edward Nejat, MD, Serin Seckin, MD, Alicia Broussard,
PhD
Performance Site(s): Generation Next Fertility
Funded by:
[ ] Intramural funds
[x ] Other: Generation Next Fertility
Requested time period for approval of project: 60 days
In submitting this project, I declare that:
[x ] None of the investigators has any conflict to declare that in any form

whatsoever may be relevant to conduct of this research project.
[ ] The following potential conflicts exist: _________________________ 7
__________________________________________________________
All potential significant conflicts, involving all investigators, shall be listed. This means that
every
significant financial interest that reasonably would appear to be affected by the research
activity or
interest in entities whose financial interests would reasonably appear to be affected by the
research
activity. Conflicts also include family interests of spouses and children. Use additional
page, if
required.
II. STUDY DESIGN:
Human Subjects: YES [ x] NO [ ]
If YES, describe in detail in section below how human subjects will be involved. Specifically
indicate if only human materials and/or human medical records are involved in the study
and
no experimentation, involving patients directly, is proposed. If research does not involve
intact
human, indicate how material(s) will be obtained (i.e., pathologic discards, surgical
specimens,
donations of body fluids, etc). You also have to indicate number of patients expected to be
investigated, whether they will be adults or minors and age ranges. If medical records are
used , describe any potential psychological and sociological risk to patients (if any) and
note in application that all GNF patients at time of first consultation sign informed
consents, which allows for the review of their medical records as long as their identities
remain undisclosed in the process and medical records remain confidential. Indicate in
your application how these conditions will be met. Also indicate whether study involves
randomization, placebo use and describe each study group in detail. Indicate whether
study subjects receive a fee to participate or any other inducement (s). Use additional
page if required.
Experimental Drugs (new drug usage or dosage): YES [ ] NO [x ]
Experimental Device: YES [X] NO [ ]
If YES for either one, describe in detail how human subjects will be involved.
The AI software, an investigational device in the US, is based on convolutional neural
networks (CNN) and is intended as a support tool designed to evaluate early embryo
development using time-lapse videos. It provides automatic annotations of human
embryos and predicts embryo viability. The software is intended for use by professional
embryologists, laboratory personnel, and clinical staff at IVF clinics. The AI software may
be considered a non-significant risk (NSR) device, as it does not direct patient
management, alter clinical decisions, or interfere with the standard of care. Its output is
for observational and investigational purposes only. In the context of this protocol,
subjects and embryos do not directly benefit from the investigational AI device, as the

protocol does not affect the standard of care or treatment. The AI outcome may be shared
with participants, the research outcomes may facilitate an improvement in IVF patient
care, which may potentially benefit the subject.
Informed Consent:
Does study involve obtaining a full informed consent? YES [x ] NO [ ]
If YES, attach copy of full written informed consent proposed for this study. If no consent is
to
be obtained, attach written justification why no consent is obtained. Indicate whether a
STANDARD or ABBREVIATED informed consent form will be used. Standard consents must
contain all required elements for informed consent. Abbreviated consents (a short
one-page
consent) shall be used only in studies which only involve blood donations from healthy
subjects in
amounts not exceeding 450ml in one 8-week period and not more often than twice
weekly.
Further details on the requirements of full informed consent are listed below in Section III
(Informed Consent Information)
Criteria why no consent may be obtained are:
(i) Research involves no more than minimal risk to research subjects, with minimal risk
being defined by IRB policy, based on internationally practiced criteria.
(ii) Omitting a consent will not adversely affect rights and welfare of study subjects.
(iii) The research could not practically carried out without a waiver of consent.
(iv) Whenever appropriate, study subjects will receive additional pertinent information
after
participation.
Recruitment of Study Subjects:
Does study recruitment involve advertisement? YES [x ] NO [ ]
If YES, attach copy of proposed advertisement for prior approval by IRB.
Agreement of Human Subjects: As PI I agree to bring any proposed significant changes in
this research
project or in its activities, that may affect human subjects, immediately to the
attention of the IRB for its approval. I also agree to bring any emerging
problems for review and recommendations to the attention of the IRB.
JH
_____________________
Initials
III. INFORMED CONSENT INFORMATION
The following information and phrases (here listed under “____ “) must be
contained in a STANDARD informed consent:

(i) PROTECTED HEALTH INFORMATION:
“All information in regards to your health is personal and GNF is obliged to protect the
privacy of that information. We herby remind you that, upon becoming a GNF patient, you
gave us in writing permission to disclose your protected health information for research
purposes, as long as such disclosure does not reveal your identity and or breach the
confidentiality of that information. We here want to make certain that you are properly
informed how this information will be used in research and/or disclosed, assuring
continuous confidentiality.
By signing this consent form you reaffirm your permission. You, however, have no
obligation to sign this reaffirmation and such refusal will in no way affect your clinical care
at GNF.”
“All medical information in your medical record at GNF may be subject to review as part of
this study. This means that members research team at GNF, conducting this study, may
have access to your protected health information, even if they have not been part of the
clinical team, providing medical care to you at GNF. Your information may also be
reviewed by members of the Institutional Review Board (IRB) of GNF, which is a
community board, charged with assuring that all research at GNF is conducted in
accordance with generally accepted rules that protect human rights of research
participants. Your information may also be
shared with potential sponsors of research, conducted at GNF, and their agents, the U.S.
Food and Drug Administration (FDA) and/or the U.S. Office for Human Research Protection
of the U.S. Department of Health and Human Services. Finally, your data may also be
shared with colleagues at other medical centers, participating and/or collaborating in
GNF’s research.”
“Your health information will be kept for at least 10 years, but possibly indefinitely, and
your authorization, therefore, does not expire. You, however, can cancel your
authorization at any time, though already authorized and used data cannot be withdrawn.”
“You may ask to see your health information used for this study, but you may have to wait
until the end of the study since many study protocols do not allow interim analysis of
study data.”
“While we make every possible effort to maintain confidentiality of your medical
information and of your identity, we cannot offer an absolute guarantee that we will be
successful. While all individuals, given access to this information during the study normally
protect the privacy of your medical information, they may not be required to do so by
law.”
“Once you sign, you will be given a copy of this informed consent.”
(ii) LANGUAGE RECOMMENDATIONS:
Use “you are being asked to ……” rather than “ I agree to participate in
….”
Make the consent form “user friendly:” Use lay language; Avoid
complicated and long sentences; Avoid statements that could be perceived
as coercive.
(iii) 8 REQUIRED ELEMENTS:
(1) Purpose of study
(2) Risks and discomforts

(3) Benefits (if any)
(4) Alternatives to participation
(5) Confidentiality [see (i)]
(6) Research-related injury: Must include statement as to whether any
compensation and/or medical treatments are available if injury occurs
and, if so, provide details. Also detail who should be contacted, and
how, in case of injury.
(7) Offer to answer questions: Must include who will be available to do so.
(8) Stress the voluntary nature of all participation [see (i)]. 10
(iv) RECOMMENDED ADDITIONAL ELEMENTS (where appropriate):
(1) A statement that potential risks to patients and offspring (embryo or
fetus) may currently be unforeseeable.
(2) A statement that describes circumstances under which a subject’s
participation in the study may be terminated by investigators without
regard to the subject’s concerns.
(3) A statement that describes additional costs for the subject (if any) that
may result from participation in the research study. Example: “Your
participation in this study should not result in costs other than those associated with
treatment of your medical condition. The study sponsor will supply study drugs and cover
treatment costs at no cost to you.” Or: “Some tests and procedures, which are part of your
regular care, will not be paid by the study sponsor. Your insurance carrier will be charged
for the costs of that care. Some insurance carriers, however, limit what they will pay for
routine services, if conducted as part of a research study. In such a case you may be
responsible for such costs.”
(4) A statement that describes the consequences of a study subject’s
decision to withdraw from the research, and procedures for orderly
termination of participation.
(5) A statement that significant new findings, developed during the course
of the research, which may relate to the subjects’ willingness to
participate, will be provided.
(6) A statement as to the approximate anticipated number of subjects
involved in the study.
IV. PRINCIPAL INVESTIGATOR (PI) ASSURANCE
AS PI, I CERTIFY THAT THE INFORMATION SUBMITTED WITHIN THE
ACCOMPANYING APPLICATION IS, TO THE BEST OF MY
KNOWLEDGE, TRUE, COMPLETE AND ACCURATE. I AM AWARE
THAT ANY FALSE, FICTITIOUS OR FRAUDULENT STATEMENTS OR
CLAIMS MAY SUBJECT ME TO CRIMINAL, CIVIL OR
ADMINISTRATIVE PENALTIES. I AGREE TO ACCEPT RESPONSIBILITY
FOR THE SCIENTIFIC CONDUCT OF THE PROJECT AND TO PROVIDE

THE REQUIRED PROGRESS REPORTS IF THIS PROJECT IS APPROVED
BY GNF’s IRB AS A RESULT OF THIS APPLICATION.