Ovarian Platelet-Rich Plasma Injections for Diminished Ovarian Reserve Patients: A Double-Blinded Placebo-Control Trial
Phase: NA
Conditions: Diminished Ovarian Reserve
Sponsor: Generation Next Fertility

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RESEARCH SUBJECT OVARIAN PLATELET RICH PLASMA INJECTIONS 
INFORMATION & CONSENT FORM 
 
 
 
Title:  OVARIAN PLATELET-RICH PLASMA (OPRP) INJECTIONS 
FOR DIMINISHED OVARIAN RESERVE PATIENTS: A DOUBLE-
BLINDED PLACEBO-CONTROLLED TRIAL  
(IRB STUDY#: IORG0010499_202301) 
 
Sponsor: 
 
 
Generation Next Fertility, Igenomix 
 
 
 
 
 
 
Investigators: 
Jesse J. Hade MD, Janelle Luk MD, Edward Nejat MD, 
Alicia Broussard PhD 
 
 
 
 
 
115 East 57th Street, 11th Floor 
 
 
 
 
New York, NY 10022 
 
 
 
 
Phone: (212) 641-0906 
 
 
 
 
Fax: (212) 641-0522 
 
 
 
 
E-Mail: J.hade@generationnextfertility.com 
 
 
 
 
 
 
 
 
 
 
Study Approved by GNF IRB Committee 
First approved draft 2/13/2023 
Approved Revised edits 3/16/2023 
 
 
 
 
 
 
 
 
 

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RESEARCH SUBJECT OVARIAN PLATELET RICH PLASMA INJECTIONS 
INFORMATION & CONSENT FORM 
 
 
 
Title:  OVARIAN PLATELET-RICH PLASMA (OPRP) INJECTIONS 
FOR DIMINISHED OVARIAN RESERVE PATIENTS: A DOUBLE-
BLINDED PLACEBO-CONTROLLED TRIAL  
(IRB STUDY#: IORG0010499_202301) 
 
Sponsor: 
 
 
Generation Next Fertility, Igenomix 
 
 
 
 
 
 
Investigators: 
Jesse J. Hade MD, Janelle Luk MD, Edward Nejat MD, 
Alicia Broussard PhD 
 
 
 
 
 
115 East 57th Street, 11th Floor 
 
 
 
 
New York, NY 10022 
 
 
 
 
Phone: (212) 641-0906 
 
 
 
 
Fax: (212) 641-0522 
 
 
 
 
E-Mail: J.hade@generationnextfertility.com 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
INTRODUCTION 

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Before agreeing to participate in this research study, you must read and 
understand the following explanation of the proposed research study. This consent 
document describes the study's purpose, procedures, benefits, risks, discomforts, and 
precautions. It also describes the alternative procedures and your right to withdraw from 
the study at any time. No guarantees or assurances can be made as to the results of the 
study. 
 
 
If you are not entirely truthful with your study doctor regarding your health 
history, you may harm yourself by participating in this study. 
 
 
The study is being conducted for Generation Next Fertility PLLC. Generation 
Next Fertility employs your study doctor as a physician and a medical staff member.  
 
 
Generation Next Fertility Institutional Review Board committee (GNF IRB) has 
approved the information in this consent document and has approved for the study doctor 
to do the study.  An institutional review board (IRB) is an independent committee 
established to help protect the rights of research subjects; this does not mean the IRB has 
approved your participation in the study. You must think about the information in this 
consent document for yourself.  You must then decide if you want to be in the study. 
 
In case of emergency, please call Dr. Jesse J. Hade at (212) 641-0906 
 
 
 
 
 
This consent form may contain words that you do not understand. Please ask the 
study doctors or staff to explain any word or information you do not clearly understand. 
You may take home an unsigned copy of this consent form to consider or discuss with 
family or friends before deciding. 
 
 
You have been asked to participate in a research study involving undergoing 
surgery to inject your own ovarian serum with or without a concentration of platelets 
before taking hormonal drugs to undergo In-Vitro Fertilization (IVF) and embryo 
transfer. The following explanations have been provided for your benefit. You must 
clearly understand this information before initialing each page and signing your name on 
the final page. 
 
PURPOSE OF THIS RESEARCH 
 
This prospective double-blinded randomized placebo-controlled 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.  
 

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IVF was first successfully employed on humans in 1978 during an unstimulated natural 
cycle. Due to the limited success of natural IVF cycles, gonadotropins were introduced to 
stimulate the growth and maturation of multiple antral follicles before oocyte retrieval. 
Over the years, this technique of ovarian stimulation before an oocyte retrieval has helped 
improve the success of IVF by increasing the number of mature oocytes collected and, 
ultimately, the chance of pregnancy and live birth. However, this process is expensive, 
and patients with DOR have little to no improvement in the number of mature oocytes 
retrieved and overall treatment success. For poor prognosis patients, oPRP is a novel 
therapeutic option with promising results.  
 
 
Autologous platelet-rich plasma was introduced as a transfusion product by 
hematologists in the 1970s and prescribed as a therapeutic treatment for patients suffering 
from thrombocytopenia.  PRP describes plasma with a platelet count above that of 
peripheral blood. Since its introduction, PRP has transcended its initial application and 
currently has many uses, including tissue regeneration and wound healing.  PRP is 
utilized in various medical fields, including orthopedics, cardiothoracic surgery, plastic 
surgery, dermatology, dentistry, and diabetic wound healing.i,ii The benefits of PRP on 
both ovarian and endometrial rejuvenation have been postulated based on data 
extrapolated from prior medical research.iii  It is speculated that patients with diminished 
ovarian reserve, menopause, premature ovarian failure, and thin endometrial lining may 
benefit from autologous PRP injections and infusions.  However, most of the information 
demonstrating the benefit of PRP on ovarian reserve and oocyte quality is limited to 
anecdotal evidence. To date, no large-scale randomized placebo control trial has been 
conducted to determine the true benefits and efficacy of ovarian PRP injections on 
patients undergoing in vitro fertilization (IVF) and embryo transfer.  
 
This study is intended to evaluate the benefit of oPRP when compared to a placebo. 
Ovarian PRP is suspected to improve the antral follicle count (AFC) or number of 
immature follicles for ovarian stimulation, the number of oocytes retrieved during IVF, 
and the number of embryos and euploid blastocysts formed following fertilization.  
 
Participants in this study will receive the following compensation:  
• Two significantly reduced IVF cycles with intracytoplasmic sperm injection 
(ICSI) and preimplantation genetic testing for aneuploidy (PGT-A). 
• At least one free frozen embryo transfer (FET) cycle when an embryo is available 
and deemed eligible for transfer.   
• Freezing of all additional blastocyst embryos formed and not transferred, with up 
to 1 year of free storage.   
• All additional FET cycles will be included for free, for up to 1 year following the 
initial ET or 12 months from the date of her oocyte retrieval if an embryo transfer 
is not performed. 
 
Participants (with insurance if covered) will be responsible for the following: 
• All fees and charges associated with embryo storage and embryo transfer (ET) 
starting one year after the initial ET or oocyte retrieval if no embryo transfer is 
performed. 

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• All fees and charges associated with pregnancy, if it occurs, excluding the first 
pregnancy test. 
• All IVF cycle medication costs and all charges incurred for non-study procedures 
and treatments including the initial consultation with ultrasound and bloodwork, 
uterine evaluation with hysteroscopy, and endometrial biopsy. 
 
 
 
STUDY DESIGN 
 
A randomized, double-blind, placebo-controlled trial comparing ovarian injection 
of platelet-rich plasma vs. placebo in women diagnosed with diminished ovarian reserve 
at-risk for a poor ovarian response (POR) between 35 to 42 years of age. Participants for 
this study include patients who are planning to undergo IVF with PGT-A followed by a 
frozen embryo transfer cycle. Only patients with either a euploid embryo or eligible 
mosaic embryo (following consultation with a geneticist), as determined by PGT-A, will 
be allowed to proceed with a single blastocyst FET cycle 
 
All patients will have a baseline ultrasound and blood work at the time of menses, 
approximately one month before starting their initial IVF cycle. Routine monitoring will 
be required to determine the day of ovulation. Once an lutenizing hormone (LH) surge is 
detected or if a lead follicle on pelvic ultrasound is deemed significant enough to induce 
ovulation, a "trigger" shot with 250 mcg/0.5 mL of Ovidrel® (human chorionic 
gonadotrophin or hCG) will be self-administered subcutaneously (SQ). Based upon the 
patient's randomization, either oPRP or ovarian Serum (oS) injections will be performed 
under anesthesia and within 72 hours from the day of ovulation. Following their ovarian 
injections, all patients will return for monitoring with the onset of menses approximately 
14 to 16 days from the date of ovulation.   
 
A medication protocol will be determined at the start of each IVF cycle. Either a 
natural IVF protocol (nIVF), mild IVF protocol (mIVF), or conventional IVF protocol 
(cIVF) will be chosen by the treating physician. This determination will be based on 
findings from the repeat pelvic ultrasound with AFC and blood work for anti-mullerian 
hormone (AMH), follicle stimulating hormone (FSH), lutenizing hormone (LH), estradiol 
(E2), progesterone (P4), and beta-human chorionic gonadotrophin (B-hCG). Natural IVF 
will be considered for patients with only 1-2 antral follicles, mIVF for patients with 2-4 
antral follicles observed, and cIVF for patients with four or more antral follicles 
visualized at the time stimulation started.  
 
 Patients will begin their designated protocol and return four to five days 
following medication start. A repeat pelvic ultrasound will be performed to measure the 
growth and size of all follicles visualized along with the endometrial thickness. Also, 
blood work for E2, FSH, LH, and P4 will be obtained. Monitoring for follicular and 
endometrial development will continue routinely and as needed, until the majority of all 
follicles observed have a mean diameter between 15 to 22 mm. Induction of ovulation 

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will commence 35-and-a-half hours prior to oocyte retrieval, by self-administration of 
10,000 IU hCG SQ.  
 
The patient will receive deep sedation total IV anesthesia by a board-certified 
anesthesiologist for her oocyte retrieval and placement of either her second oPRP or oS 
injections. Using transvaginal ultrasound guidance, all follicles visualized under 
ultrasound will be aspirated using standard practices by patients undergoing IVF at GNF. 
Aspirates will be collected in 10 ml test tubes. All oocytes will be assessed for maturity 
two hours post-retrieval. All oocytes that are deemed mature (MII) will undergo 
intracytoplasmic sperm injection (ICSI), to maximize fertilization rates, 2-4 hours after 
identification of the first polar body. All immature (non MII) oocytes will be isolated 
under a stereomicroscope and transferred into maturation media and incubated further in 
a triple gas mixture (90% N2, 5% CO2, and 5% O2) for up to 24 hours to allow 
maturation prior to ICSI. Following the oocyte retrieval, either oPRP or oS will be 
performed as described previously. 
 
Monitoring will recommence two weeks following the first oocyte retrieval to 
identify if any residual follicles or ovarian cysts are present. If the ovaries are deemed 
resting and no active ovarian cysts persist, then the patient will begin her second IVF 
cycle. Again, the medication protocol will be determined by findings observed on pelvic 
ultrasound including AFC and ovarian hormone testing. If the patient is deemed 
ineligible to start another IVF cycle, then she will return with the following menstrual 
period to begin her second IVF cycle. The process of monitoring patients, inducing 
ovulation, and collecting oocytes will be identical to the first oocyte retrieval. However, 
no additional oPRP or oS injections will be performed. 
 
 
NUMBER OF SUBJECTS / LENGTH OF PARTICIPATION 
 
The study population will be obtained from registered patients at Generation Next 
Fertility PLLC and include only those patients diagnosed with DOR based on the 2011 
Bologna criteriaiv and who are between the ages of 35 to 42 years old and who are 
candidates for IVF and oPRP. All patients enrolled in the study will meet the standard 
requirements of our IVF and oPRP program. No individual will be enrolled for more than 
two IVF cycles and all patients will sign a consent form in English.  
 
In short, patients will be eligible if they have a history of regular menstrual cycles defined 
as menses occurring on a routine basis between 21 to 35 days with less than five days of 
variability between cycles and at least two of the following three criteria are present:  
 
(1) Advanced maternal age (>40 years) or any other risk factor for poor ovarian response 
(POR).  
(2) A previous POR (≤3 oocytes retrieved with a conventional stimulation protocol). 
(3) An abnormal ovarian reserve test: antral follicle count (AFC) less than 7 follicles or 
an AMH below 1.1 ng/ml.  
 

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To determine the number of participants for this study, we used the Stata 15 
software (StataCorp, College Station, TX). Using a two-sided statistical test, a probability 
of Type I error (α) = 0.05 and a probability of Type II error (β) = 0.10, we calculated the 
minimum sample size needed to detect a difference between the experimental and control 
groups of 40% for average number of blastocysts formed as well as 50% or 60% for 
average numbers of immature oocytes (MI) and mature oocytes (MII) retrieved. Since 
these parameters are continuous variables, we assumed that we will be conducting 
independent sample t-tests. We relied on the preliminary data from the two retrospective 
studies performed at Generation Next Fertility (GNF) as well as data from GNF's clinical 
database to perform sample size calculations.  
 
A maximum of 230 participants will be enrolled in the study. This study 
population will be divided into two groups of 115 patients and block-randomized based 
on age, AFC, and AMH. Patients will then be randomly selected and enrolled into either 
the study group, which receives oPRP injections or the control group, which receives 
only ovarian serum (oS) injections. 
 
This study is intended to evaluate the potential benefit of oPRP when compared to a 
placebo. Ovarian PRP is suspected to improve the AFC formed for ovarian stimulation, 
the number of oocytes retrieved during IVF, and the number of embryos, blastocysts, and 
euploid blastocysts formed following fertilization. This study is designed and powered to 
analyze a suspected increase in the number of blastocyst embryos formed. Secondary 
parameters such as the number of euploid blastocysts formed and the number of 
pregnancies and live births will also be calculated for both groups. Participants in this 
study will be compensated by having two significantly reduced-cost IVF cycles with ICSI 
and PGT-A and at least one free FET cycle when an embryo is available and deemed 
eligible for transfer. They will also be eligible to freeze all additional blastocyst embryos 
formed and not transferred for up to 1 year for free. All additional FET cycles will be 
included for free for up to 1 year following the initial embryo transfer or 12 months from 
the date of her oocyte retrieval if no embryo transfer is performed. After this time, the 
patient will be responsible for all fees and charges associated with embryo storage and 
embryo transfer following the 1-year grace period. The patient will also be responsible 
for all fees and charges associated with pregnancy, if it occurs, excluding her first 
pregnancy test.  
 
Following completion or termination of this study, and if oPRP is found to improve 
IVF success rates, then all control group patients who received ovarian serum injections 
will be eligible for up to two free oPRP injection treatments. This will only apply for 
patients that elect to proceed with at least one additional IVF cycle at the standard price 
and cost to patients undergoing IVF with or without PGT-A treatment at Generation Next 
Fertility. 
 
 
WASHOUT 
 

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You will be asked to stop taking any hormonal contraception or estrogen supplements for 
at least 30 days prior to starting treatment. This is called a washout period, during which 
the effects of these medications leave your body. 
 
PROCEDURES & EXPECTATIONS 
 
SCREENING TESTS: 
 
Prior to entry into the study and starting treatment, all subjects diagnosed with DOR 
will undergo a consultation with a complete medical history and a targeted physical 
examination. A pelvic vaginal ultrasound will be performed to determine a baseline AFC 
and ascertain if the patient meets the entry criteria for participation in the study. If the 
patient meets the entry criteria, then additional bloodwork for a complete blood count 
(CBC) and ovarian reserve testing will be performed including Anti Mullerian hormone 
(AMH), follicle-stimulating hormone (FSH), and estradiol (E2) levels. Both the patient 
and her partner will require sexually transmitted disease testing for HIV, syphilis, 
Hepatitis B surface antigen (HBsAg), and Hepatitis C antibody (HcAb). The patient will 
also have urine cultures for both Gonorrhea and Chlamydia. In addition, ABO blood 
group identification, Rho typing & and genetic carrier screening will be offered to both 
the patient and her partner. Prior to embryo transfer, all patients will be screened for 
immunity against Rubella and Varicella. Patients not immune will be offered vaccination 
and then allowed to proceed with embryo transfer 1-3 months after completion of 
vaccination. A semen analysis will be performed for the patient's partner to determine if a 
male factor for infertility exists.   
 
Because some of these tests are performed on specific days of your menstrual cycle, 
two to three visits to Generation Next Fertility may be required to complete the screening 
process.   We require that you avoid excessive alcohol, vaping, cigarette smoking, and 
recreational drug usage during your participation in this study. 
 
ALL DOR STUDY PATIENTS 
 
INDICATIONS: 
All study patients must meet the definition of DOR but may be married or single and 
may use their partner's sperm or anonymous donor sperm. 
 
INITIAL CONSULTATIONS: 
Prior to your acceptance into the study, you will be required to have an initial 
consultation, which will include a meeting with Dr. Jesse Hade to review your medical 
history, and at that time a physical examination will be performed. All potential study 
participants will undergo all the necessary screening required for both oPRP injections 
and IVF with embryo transfer (as outlined above). If you meet these requirements and are 
not excluded based on the below criteria, you will be notified of your acceptance into the 
study. 
 

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EXCLUSION CRITERIA 
Exclusion criteria include a prior or known diagnosis of premature ovarian failure or 
menopause, irregular menses (menstrual cycles <21 or >35 days or having more than 5 
days of variability between menstrual cycles, history of a persistent ovarian pathology on 
pelvic ultrasound, history of recurrent pregnancy loss (defined as 2 or more consecutive 
pregnancy losses with no prior live birth) patients with known surgically untreated 
hydrosalpinx or a known history of uterine anomalies or endometrial pathology as 
deemed by hysteroscopy, any medical illness or condition where pregnancy is a 
contraindication, or any prior history of oPRP injections. Patients will also be excluded 
from participation if they have any factor in which PRP is contraindicated such as a 
history of any prior cancer including lymphoma, leukemia, breast or any gynecologic 
malignancy, or borderline ovarian tumors. Patients with a current or known history of any 
blood disorder including anemia, thalassemia, sickle cell disease, and any platelet 
dysfunction or disease including polycythemia will be excluded. Untreated or poorly 
controlled autoimmune diseases such as lupus, diabetes, and thyroid disease will also 
preclude enrollment. Patients whose partners have severe male factor infertility or with 
failed fertilization despite prior IVF and ICSI will also be excluded from this study. 
 
Please remember that there are other forms of drugs, such as smoking & alcohol, 
which we discourage & that it is extremely important that you take medications as 
directed 
 
 
IVF Protocols: 
 
nIVF Protocol: 
 
1. Prior to starting their first IVF cycle, all patients will be monitored from the onset 
of menses until ovulation occurs. Within 72 hours from ovulation, the first 
ovarian injection with either oPRP or oS will occur. The patient will have a 
hysteroscopy during this same procedure to identify and possibly treat any 
underlying endometrial abnormalities.  
2. When the patient's next menses occurs, the first IVF cycle will commence, and 
the patient will return for baseline ultrasound and blood work. 
3. Repeat monitoring of the patient will start 4-5 days following her baseline 
ultrasound and blood work and then roughly every 1-4 days to evaluate the 
growth of all follicles visualized. Once a lead follicle is found between 14-15 mm 
in diameter or if her LH rises ≥30% over baseline levels, a GnRH antagonist will 
be started to prevent premature ovulation along with 75 to 150 IU of Menopur® 
to allow folliculogenesis to continue.  
4. 10,000 IU of HCG or 250 mcg of Ovidrel® will be self-administered SQ by the 
patient when a lead follicle of 17 mm or greater is visualized. 
5. Approximately 35.5 hours after HCG administration, the patient will undergo an 
oocyte retrieval using a long 19-gauge aspiration needle followed by their second 
ovarian injection with either PRP or serum. 

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6. All eligible oocytes following retrieval will undergo the ICSI procedure for 
fertilization. 
7. Fertilization will be evaluated the following day to verify the number of polar 
bodies observed and if the normal pronuclear stage of embryonic development is 
reached. On day three of culture, all cleaving stage embryos will be evaluated and 
graded for cell number, fragmentation rate and overall cell symmetry. A grade of 
1-4 will be assigned to each embryo at this time. Next, laser assisted hatching 
(LAZ) using ZILOS-tk® will be performed on the zona pellucida of all embryos. 
Incubation to the blastocyst stage will proceed using continuous culture in micro-
drops with group cultivation. On days five through seven of embryonic culture, 
embryos reaching a blastocyst stage of 3BB or better, based on the Gardner 
grading system, will be biopsied for PGT-A analysis. Briefly, five to eight cells 
are biopsied using the ZILOS-tk® laser and the cells are then placed in 
microcentrifuge tubes per protocol by Igenomix® and later sent for analysis. All 
embryos biopsied are then vitrified using cryo-lock vitrification tubes. Remaining 
embryos which arrest in development and do not meet the above criteria for 
biopsy will be discarded. 
8. Patients will next return for monitoring with the onset of menses, approximately 
two weeks following their first oocyte retrieval and ovarian injections. If eligible, 
a second IVF cycle will commence, and a stimulation protocol will be determined 
based on the above criteria. 
 
 
mIVF Protocol: 
 
1. Prior to starting their first IVF cycle, all patients will be monitored from the onset 
of menses until ovulation occurs. Within 72 hours from ovulation, the first 
ovarian injection with either oPRP or oS will occur. The patient will have a 
hysteroscopy during this same procedure to identify and possibly treat any 
underlying endometrial abnormalities. 
2. When the patient's next menses occurs, the first IVF cycle will commence and the 
patient will return for a baseline ultrasound and blood work. Three days following 
the onset of menses the patient will begin a combination of medications including 
an oral medication of Letrozole and/or Clomiphene Citrate in conjunction with a 
daily SQ injection of FSH (Follistim® or Gonal-F®) at a dosage not to exceed 
225 IU daily. 
3. Repeat monitoring of the patient will start 4-5 days following her baseline 
ultrasound and blood work and then roughly every 1-4 days to evaluate the 
growth of all follicles visualized. Once a lead follicle is found between 14-15 mm 
in diameter or if her LH rises ≥30% over baseline levels, a GnRH antagonist will 
be started to prevent premature ovulation along with 75 to 150 IU of Menopur® 
to allow folliculogenesis to continue. All oral medication will be discontinued at 
this time and the dosage of FSH lowered so not to exceed the total daily dosage of 
225 IU of FSH. 

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4. 10,000 IU of HCG or 250 mcg of Ovidrel® will be self-administered SQ by the 
patient when the lead follicle has a mean diameter of 17 mm or greater and the 
majority of subordinate follicles have a mean diameter of ≥15 mm. 
5. Approximately 35.5 hours after HCG administration, the patient will undergo an 
oocyte retrieval using a long 19-gauge aspiration needle followed by their second 
ovarian injection with either PRP or serum. 
6. All eligible oocytes following retrieval will undergo the ICSI procedure for 
fertilization. 
7. Fertilization will be evaluated the following day to verify the number of polar 
bodies observed and if the normal pronuclear stage of embryonic development is 
reached. On day three of culture, all cleaving stage embryos will be evaluated and 
graded for cell number, fragmentation rate and overall cell symmetry. A grade of 
1-4 will be assigned to each embryo at this time. Next, laser assisted hatching 
(LAZ) using ZILOS-tk® will be performed on the zona pellucida of all embryos. 
Incubation to the blastocyst stage will proceed using continuous culture of micro-
drops with group cultivation. On days five through seven of embryonic culture, 
embryos reaching a blastocyst stage of 3BB or better, based on the Gardner 
grading system, will be biopsied for PGT-A analysis. Briefly, five to eight cells 
are biopsied using the ZILOS-tk® laser and the cells are then placed in 
microcentrifuge tubes per protocol by Igenomix® and later sent for analysis. All 
embryos biopsied are then vitrified using cryo-lock vitrification tubes. Remaining 
embryos which arrest in development and do not meet the above criteria for 
biopsy will be discarded. 
8. Patients will next return for monitoring with the onset of menses, approximately 
two weeks following their first oocyte retrieval and ovarian injections. If eligible, 
a second IVF cycle will commence, and a stimulation protocol will be determined 
based on the above criteria. 
 
cIVF Protocol: 
 
1. Prior to starting their first IVF cycle, all patients will be monitored from the onset of 
menses until ovulation occurs. Within 72 hours from ovulation, the first ovarian 
injection with either oPRP or oS will occur. The patient will have a hysteroscopy 
during this same procedure to identify and possibly treat any underlying endometrial 
abnormalities. 
2. When the patient's next menses occurs, the first IVF cycle will commence, and the 
patient will return for baseline ultrasound and blood work. Three days following the 
onset of menses the patient will begin injectable medications with a daily SQ 
injection of FSH (Follistim® or Gonal-F®) at a dosage of 225 to 300 IU plus 75 to 
150 IU of Menopur® with the total dosage of FSH not to exceed 450 IU daily. 
3. Repeat monitoring of the patient will start 4-5 days following her baseline ultrasound 
and blood work and then roughly every 1-4 days to evaluate the growth of all 
follicles visualized. Once a lead follicle is found between 14-15 mm in diameter or if 
her LH rises ≥30% over baseline levels, a GnRH antagonist will be started to prevent 
premature ovulation.  

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4. 10,000 IU of HCG or 250 mcg of Ovidrel® will be self-administered SQ by the 
patient when the lead follicle has a mean diameter of 17 mm or greater and the 
majority of subordinate follicles have a mean diameter of ≥15 mm. 
5. Approximately 35.5 hours after HCG administration, the patient will undergo an 
oocyte retrieval using a long 19-gauge aspiration needle followed by their second 
ovarian injection with either PRP or serum. 
6. All eligible oocytes following retrieval will undergo the ICSI procedure for 
fertilization. 
7. Fertilization will be evaluated the following day to verify the number of polar bodies 
observed and if the normal pronuclear stage of embryonic development is reached. 
On day three of cultivation, all cleaving stage embryos will be evaluated and graded 
for cell number, fragmentation rate and overall cell symmetry. A grade of 1-4 will be 
assigned to each embryo at this time. Next, laser assisted hatching (LAZ) using 
ZILOS-tk® will be performed on the zona pellucida of all embryos. Incubation to the 
blastocyst stage will proceed using continuous culture of micro-drops with group 
cultivation. On days five through seven of embryonic culture, embryos reaching a 
blastocyst stage of 3BB or better, based on the Gardner grading system, will be 
biopsied for PGT-A analysis. Briefly, five to eight cells are biopsied using the 
ZILOS-tk® laser and the cells are then placed in microcentrifuge tubes per protocol 
by Igenomix® and later sent for analysis. All embryos biopsied are then vitrified 
using cryo-lock vitrification tubes. Remaining embryos which arrest in development 
and do not meet the above criteria for biopsy will be discarded. 
8. Patients will next return for monitoring with the onset of menses, approximately two 
weeks following their first oocyte retrieval and ovarian injections. If eligible, a 
second IVF cycle will commence, and a stimulation protocol will be determined 
based on the above criteria. 
 
EMBRYO TRANSFER: 
Upon completion of both IVF cycles, and if the patient has an eligible embryo 
cryopreserved, she will proceed with her first frozen embryo transfer (FET) cycle. 
Patients will be treated with standard protocols used at Generation Next Fertility and will 
be required to have an elective single embryo transfer (eSET). All study participants will 
undergo a medicated hormone replacement cycle to reduce the variability between the 
time of embryo transfer in relation to progesterone exposure. After a minimum of 11 days 
of estrogen exposure and when the endometrial lining is visualized to be ≥7mm by 
vaginal ultrasound, 50 to 75 mg of intramuscular (IM) progesterone will be started daily. 
On the sixth day of progesterone exposure, the patient will have her embryo transferred. 
 
A serum pregnancy test will be conducted nine to ten days after the embryo 
transfer. If this serum pregnancy test is positive, the second serum pregnancy test will be 
performed two to three days later. If the second serum pregnancy test is positive, a 
transvaginal ultrasound will be performed within two weeks to confirm the pregnancy 
placement and number of gestational sacs and yolk sacs. This will be repeated one to two 
weeks later. However, if the patient has a negative serum pregnancy test, then the FET 
cycle process can be repeated if and only if she has additional embryos deemed eligible 

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for transfer. All patients with eligible embryos for transfer must transfer their embryos 
within 12 months of starting this study. 
 
Embryo transfer is usually performed with the woman in a reclining position with 
legs up (as if having a PAP smear) using a sterile technique. You may eat and/or drink 
before the procedure unless directed otherwise. Following the embryo transfer you will 
be given an appointment for your pregnancy test. You should then go home and relax for 
the rest of the day. 
 
RISKS & SIDE EFFECTS 
 
The treatment used in this study may cause some or none of the side effects listed. In 
addition, there is always the risk that some uncommon or unknown side effects may 
occur including death.  
 
Risks/Side Effects Associated with Estrogen and Progesterone Supplementation:   
Side effects reported in women treated with hormones such as estrogen and progesterone 
include nausea and vomiting, breast tenderness or enlargement, enlargement of benign 
tumors ("fibroids") of the uterus, retention of excess fluid leading to worsening 
conditions such as asthma, epilepsy, migraine headaches, heart disease, or kidney disease. 
Patients may also experience a spotty darkening of the skin, particularly on the face. 
These hormones may increase the patient's ability to form blood clots and increase the 
chance of a blood clot developing in the blood vessels of the leg or pelvis.This can then 
lead to embolus formation (dislodging of the blood clot which then travels in the 
circulation) resulting in potentially serious damage to the lungs, heart, or brain. 
Hormones may also increase the risk for developing a stroke or heart attack and even 
death. 
 
Risks/Side Effects Associated with gonadotropin and hCG:   
Side effects reported in women treated with gonadotropins and or menotropins (Gonal-F, 
Follistim, and Menopur) include ovarian hyperstimulation syndrome, pulmonary and 
vascular complications (such as the collapse of the lungs, acute respiratory distress 
syndrome, blood clots which may lead to inflammation of the veins, obstruction of blood 
vessels in the lungs, damage to the lung tissues, stroke, and obstruction of the arteries 
resulting in loss of a limb), blood in the abdominal cavity, enlarged ovaries, dizziness, 
increase in heart rate, shortness of breath, rapid breathing, flu-like symptoms (fever, chills, 
musculoskeletal aches, joint pain, nausea, headache, and fatigue), breast tenderness, and 
dermatological (skin) reactions (dry skin, body rash, hair loss, and hives). In rare cases, 
pulmonary (lung) complications and/or thromboembolic (clots in blood vessels) events 
have resulted in death.  
 
There have been infrequent reports of ovarian cancer in women who have undergone 
multiple drug regimens for ovulation induction; however, a causal relationship has not been 
established. In addition, ovulation induction medications have been used safely and without 
long-term adverse effects on most patients. However, the long-term safety of any one 

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patient cannot be guaranteed. In addition, breast tenderness, mood swings, hot flashes, 
nausea, pain, and swelling at the injection site may occur. 
 
The following side effects have been reported in some patients receiving Ovidrel (HCG) 
therapy: Headache, irritability, restlessness, depression, fatigue, swelling, and pain at the 
site of injection. 
 
Risks Associated with Study Procedures:   
In this study, participants will be required to have blood drawn on several occasions. This 
may lead to slight pain, bruising, swelling, and the possibility of local infection. 
Participants will also be required to take subcutaneous (SQ) or intramuscular (IM) 
injection of Follistim, Gonal-F, Menopur, HCG or Ovidrel (choriogonadotropin alfa). 
There may be risk of infection, bruising, swelling at the injection site and damage to the 
nerves with improper technique. 
 
oPRP or oS injections like IVF is a surgical procedure that requires anesthesia and 
transvaginal ultrasound guided ovarian injections. Both processes are generally 
considered safe, but risks and complications have been reported from post procedural 
blood loss and infection. The performance of the ovarian oPRP or oS injections and the 
egg retrieval may be associated with infection, abscess formation, injury to abdominal 
organs, blood vessels, and subsequent death. Participants will be given oral antibiotics to 
be taken for a period of three days following the retrieval as prescribed by the physician 
to prevent risk of infection. Complications rarely require hospitalization and intervention 
with surgery, blood transfusion and IV antibiotic administration.  
 
Anesthesia is required for the egg retrieval and ovarian injection procedures. The type of 
anesthesia administered, (I.V. deep Sedation), will be decided on an individual basis by 
the anesthesiologist physician. Side effects of anesthetic agents can include nausea and 
vomiting. Allergic reactions to anesthesia agents can include skin rash and in severe cases 
cardiac arrest and death. 
 
oPRP although considered experimental, does not demonstrate any additional risks or 
complications during the retrieval of oocytes when compared to traditional IVF. Nor has 
there been any increased rate of fetal malformations or other adverse fetal events or 
ectopic pregnancies when compared to traditional IVF without oPRP. 
 
Generation Next Fertility cannot guarantee future fertility or participants. Impaired 
fertility in the future may or may not be related to the egg retrieval process or injection of 
oPRP or oS. In addition, a participant's condition may not improve or may worsen while 
participating in this study. 
 
 
All subjects will be informed of all risks associated with the oPRP and oS 
injections and the IVF process. Immediate transportation and hospitalization for the 
management of a complication will be provided to all subjects who require such 
intervention following oocyte retrieval.   
 
Commented [MB1]: change to first person POV, should this 
be a declarative statement closer to the signature line? 

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Patient Initials: __________ 
 
If you do not understand any of the above risks, you may discuss them with Dr. Hade. If 
complications occur, Dr. Hade or his associate physicians and their team will monitor 
you closely and take appropriate medical action that may include stopping any or all 
medications and discontinuing the treatment cycle.  
 
BENEFITS 
 
This research may benefit you personally by assisting you in achieving pregnancy. 
However, pregnancy cannot be guaranteed and there may be no direct benefit to you 
especially if you are part of the control/placebo group. The information obtained from 
this study may have humanitarian benefits in enabling women with DOR undergoing IVF 
to achieve pregnancy with fewer treatments and lower cost.  
 
COMPENSATION FOR PARTICIPATION 
 
The goal of this study is to identify the true benefits of oPRP. Participants in this 
study will be compensated by having two significantly reduced IVF with ICSI and PGT-
A cycles and at least one free FET cycle when an embryo is available and deemed 
eligible for transfer. They will also be eligible to freeze all additional blastocyst embryos 
formed and not transferred for up to 1 year for free. All additional FET cycles will be 
included for free for up to 1 year following the initial ET or 12 months from the date of 
her oocyte retrieval if no ET is performed. After this time, the patient will be responsible 
for all fees and charges associated with embryo storage and embryo transfer following 
the 1-year grace period. The patient will also be responsible for all fees and charges 
associated with pregnancy, if it occurs, excluding her first pregnancy test.  
 
Following completion or termination of this study, and if oPRP is found to improve 
IVF success rates, then all control group patients who received ovarian serum injections 
will be eligible for up to two free oPRP injection treatments. This will only apply for 
patients that elect to proceed with at least one additional IVF cycle at the standard price 
and cost to patients undergoing IVF with or without PGT-A treatment at Generation Next 
Fertility. 
 
Please be advised you will NOT receive any monetary compensation for your 
participation in this study. 
 
ALTERNATIVE TREATMENT 
 
You do NOT have to participate in this study as a Study or Control Patient. 
 
Alternative therapy available to patients with DOR and infertility is to undergo 
artificial intrauterine insemination (IUI), traditional IVF with typical ovarian stimulation 
and embryo transfer protocols, or oocyte donation. You also have the right to have oPRP 
injections and not participate in this study. However, all the standard GNF fees and 
charges for oPRP injections under anesthesia will apply. 
 

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CONFIDENTIALITY 
 
 
Records of your participation in this study will be held confidential except as 
disclosure is required by law or as described in this informed consent document (under 
"Confidentiality" or "Authorization to Use and Disclose Protected Health Information"). 
The study doctor, the sponsor or persons working on behalf of the sponsor, and under 
certain circumstances, the United States Food and Drug Administration (FDA) and the 
Institutional Review Board (IRB) will be able to inspect and copy confidential study-
related records which identify you by name. Therefore, absolute confidentiality cannot be 
guaranteed. If the results of this study are published or presented at meetings, you will 
not be identified. 
 
COMPENSATION FOR INJURY 
 
I understand that in order to participate in this study, I must have my own medical 
insurance and must provide documentation of such insurance. In the event that I should 
require additional medical treatment or hospitalization as a result of my participation in 
this study, either my insurance carrier or I will carry the financial responsibility for such 
care. 
 
In the unlikely event that physical injury occurs as a direct result of your participation, 
immediate medical care will be available including hospitalization. Generation Next 
Fertility will help bill the appropriate insurance company for any additional expenses, but 
neither Generation Next Fertility nor any provider or sponsor will be directly responsible 
for the costs of such care.  
 
SOURCES OF FUNDING 
 
Funding for this research study will be provided by Generation Next Fertility. 
 
EMERGENCY CONTACT/IRB CONTACT 
 
 
During the study, if you experience any medical problems, suffer a research-
related injury, or have questions, concerns, or complaints about the study, please contact 
the study doctor at the telephone number listed on page one of this consent document. If 
you seek emergency care, or hospitalization is required, alert the treating physician that 
you are participating in a research study being conducted by the study doctor listed on 
page one of this document. 
 
If you have any questions about this study, you are injured, or you experience a 
reaction to the study medication because of your participation in this study, contact: 
 
• 
Dr. Hade, Dr. Luk or Dr. Nejat at (212) 641-0906 
 
 
If you have any questions about your rights as a research subject, and/or concerns 
or complaints regarding this research study, you should write to: 
 

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Patient Initials: __________ 
 
 
      Generation Next Fertility IRB 
 
       115 East 57th Street 
 
       Suite 500 
 
       New York, NY 10022 
 
       Telephone: 212-641-0906 
 
Do not sign this consent form unless you have had a chance to ask questions and 
have received satisfactory answers to all questions. 
 
 
VOLUNTARY PARTICIPATION & WITHDRAWAL 
 
Your participation in this study is voluntary. You may decide to not participate in this 
study. If you do participate, you may freely withdraw from the study at any time. Your 
decision will not change your future medical care at Generation Next Fertility. 
 
You will be removed from the study without your consent if: 
 
1. It appears to be medically harmful to you. You experience any side effects 
that, in the opinion of your study doctors or sponsors, will endanger your 
welfare with continued use of the medications. This includes risk of ovarian 
hyperstimulation syndrome (OHSS) and hypersensitivity reactions. 
 
2. You develop an illness that increases risk of complication(s) from the oPRP, 
oS or IVF process and procedures. 
 
3. You have to take an unacceptable medication during the study (other 
hormones, anti-inflammatory drugs, and drugs which act on the nervous 
system, such as tranquilizers), chemotherapy or other medication 
contraindicated in pregnancy. 
 
4. You fail to follow directions for participating in the study. 
 
5. It is discovered that you are ineligible. 
 
6. The study is canceled or 
 
7. For administrative reasons, including competitive enrollment - the target 
number of subjects has entered the treatment phase. 
 
If you leave the study for any reason, the study doctor may ask to perform some end-of-
study tests for your safety.  
 
PRIMARY CARE PHYSICIAN / SPECIALIST NOTIFICATION OPTION 
 
Please indicate below whether you want us to notify your primary care physician or your 
specialist of your participation in this study. 

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Patient Initials: __________ 
 
________ 
Yes, I want the study doctor to inform my primary care 
physician/specialist of my participation in this study. 
 
________ 
No, I do not want the study doctor to inform my primary care 
physician/specialist of my participation in this study. 
 
________ 
I do not have a primary care physician/specialist. 
 
________ 
The study doctor is my primary care physician/specialist. 
 
NEW FINDINGS 
 
You will be told about any new information that might change your decision to be in 
this study. 
 
CONSENT 
 
I/we have had ample opportunity to ask any questions concerning this study, and my 
participation is voluntary as reflected by the signed statement below. 
 
I/we have read this consent form and have heard the verbal explanations of these 
procedures from my study doctor. I/we understand the information about this study. I/we 
freely give my consent to participate in this research. I/we understand that I/we have the 
right to ask questions and may refuse to continue participation at any time during the 
study. 
 
During the course of the research, I/we will be informed of any new significant 
findings that may relate to my willingness to continue to participate. 
 
I/we further understand that at any time during treatment, I/we are free to discuss with 
my study doctor or the study doctor's designee or a GNF Review Board, Inc. (GNF IRB) 
representative, my rights as a subject and any side effects that might occur. 
 
I/we are deciding whether to participate in this study. My/our signature(s) indicates 
that I have decided to participate, having read (or been read) the information provided in 
this consent form.  
 
I/we authorize the release of my medical records for research or regulatory purposes to 
the sponsor, the FDA, DHHS agencies, governmental agencies in other countries, and 
Schulman Associates Institutional Review Board, Inc. (Schulman). 
 
I/we understand that existing laws do not fully address the legal issues which may be 
raised by the performances of this procedure, including but not limited to the legality of 
the procedure itself, the right and obligations of the parties participating, and the legality 
and enforceability of any contract between the embryo recipient, her partner, and the 

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ovum donor with respect to custody and parentage of any child which may be born as a 
result of this procedure. I/we have been advised to seek individual legal counsel prior to 
participation into this procedure. Because of the newness of egg donation, this is an area 
with limited legal precedence and the Diamond Institute cannot assure recipients or 
donors of the enforceability of this situation. 
 
I/we understand and agree that all medical records pertaining to testing and treatment 
performed on me/my partner as part of the egg donation process are the property of the 
Diamond Institute and will not be released to me. 
 
I/we understand that Generation Next Fertility, its physicians, and their associates 
have not made or implied any guarantee or warranty to me regarding the outcome of the 
Egg Maturation process. I/we release Generation Next Fertility from any liability or 
responsibility for the physical or mental nature of any child or children produced, or loss 
or damage, including any complication, which may result from my/our participation in 
this procedure or from the application of the law to this procedure or any agreement 
between the parties. This release is intended to and shall apply to the fullest extent 
permitted by law to any rights or claims which may be held or assisted by any third party, 
including any children which may result from this procedure. 
 
I/we acknowledge that I/we have an adequate understanding of the ovarian platelet-
rich plasma/ovarian serum injections and the In-Vitro Fertilization process as described 
above and that the physicians and their associates have provided me/us with all the 
required information that I/we have requested. I/we have been made aware of the usual 
and most frequent risks and hazards inherent in the procedures and the treatment 
associated with it. I/we understand that there may be some risks that are not known at this 
time. I/we have had the opportunity to ask all pertinent questions, and these have been 
answered to my satisfaction. If I/we choose to withdraw from the study or if the study 
doctor finds it is in my best interest to withdraw, I/we acknowledge that I/we am 
expected to return for a final visit. 
 
My partner (if applicable) and I freely consent to my voluntary participation as a 
Study or Control Patient. As a subject of the study, I will be randomly selected to 
undergo either oPRP or oS injections prior to the IVF procedure and embryo transfer. I 
fully understand this procedure and accept its risks and limitations as explained to me. 
This study is designed to identify the true benefits of oPRP prior to the IVF process. I 
understand that I must undergo several surgeries to have both ovarian injections of either 
oPRP or oS followed by IVF and surgery to recover mature eggs from my ovaries. 
Following the removal of my eggs, I/we understand that they will be fertilized in the 
laboratory with sperm from my partner or chosen sperm donor. I/we understand that only 
embryos that form a viable and eligible blastocyst, as determined by the embryology staff 
at GNF, will be biopsied to determine the chromosomal normalcy prior to transfer. Only 
embryos that are deemed "normal" or "suitable" for transfer will be transferred back to 
my uterus. All embryos ineligible for transfer will be discarded. 
 

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I/we understand and authorize and consent to the performance of micromanipulation 
on all of the mature egg(s) retrieved from the IVF process. Micromanipulation 
procedures such as ICSI involve some risk to the oocyte and/or embryo. With the ICSI 
technique, only one sperm is injected into the cytoplasm of the egg. This procedure may 
reduce the risk of abnormal fertilization. However, even with this procedure abnormal 
egg(s) and sperm may be inseminated resulting in anomalous embryos. All embryos that 
are identified as abnormal will be discarded and not used for transfer. 
 
I/we understand and agree that I/we are fully responsible for any and all offspring 
regardless of the outcome of the pregnancy.  
 
I/we understand that once the egg(s) are removed from my body and have been 
inseminated with the sperm of the male partner (or chosen donor), the resulting 
embryo(s) are my/our sole responsibility. I/we understand and agree that I/we are legally 
responsible for the resulting embryos.     
 
I/we do understand that no guarantee can be given to me/us about the success of this 
procedure. I/we realize that at any time the physician may cancel the procedure based on 
his/her judgment and experience. I/we also realize that the possibility exists that no eggs 
may be retrieved from my follicles, that the retrieved eggs may not fertilize or that 
fertilized eggs may not develop into blastocyst embryos. Finally, the blastocyst embryos 
may not be eligible for either biopsy or transfer and may not implant into the uterus 
following embryo transfer. I/we understand that there is the possibility of complications 
of childbirth or delivery, or the birth of an abnormal infant or infants, or undesirable 
hereditary tendencies of such issue, or other adverse consequences, and will not hold 
Generation Next Fertility or any of its employees responsible should such complications 
occur. Generation Next Fertility cannot guarantee future fertility or participants. I/we 
understand that impaired fertility in the future may or may not be related to the egg 
retrieval process or injection of oPRP or oS. I/we acknowledge that my condition may 
not improve or may worsen while participating in this study.  
 
In consideration of the matters set forth above, I/we release Generation Next Fertility and 
its employees from any liability or responsibility for the physical or mental nature of any 
child or children produced and any loss or damage which may result from participation in 
this procedure, including any complications which may result from participation in this 
procedure or from the application of the law to this procedure or any agreement between 
the parties. 
 
This release is intended to and shall apply to the fullest extent permitted by law to any 
rights or claims which may be held or asserted by any third party, including any children 
which may result from this procedure. I/we release Generation Next Fertility and its 
employees from any financial responsibility due to complications incurred to us or our 
offspring from this procedure. I/we also understand that if pregnancy should occur, 
further testing with either amniocentesis or chorionic villous sampling (CVS) is 
recommended to help identify all possible offspring(s) with chromosomal abnormalities. 
 

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If I/we or any of my/our offspring should require medical treatment as a result of  
participation in this procedure, the financial responsibility for such care will be 
mine/ours. 

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CONSENT   
 
I/we have read and understand the information in this informed consent document. I/we 
have had an opportunity to ask questions and all of my questions have been answered to 
my satisfaction. I/we voluntarily agree to participate in this study until I/we decide 
otherwise. I/we do not give up any of my legal rights by signing this consent document. 
I/we will receive a copy of this signed consent document. 
 
_______________________________ 
 
 
 
Subject's Printed Name  
 
______________________________ 
 
 
 
__________  
Subject's Signature 
 
 
 
 
 
 
Date 
 
___ 
____________________________  
 
 
Subject Partner's Printed Name (if applicable) 
 
______________________________ 
 
 
 
__________  
Subject Partner's Signature (if applicable) 
 
 
 
Date 
 
 
Date 
 
____________________________________ 
 
 
 
Printed Name of the Person Conducting the   
 
 
Consent Discussion   
 
_____________________________________ 
 
 
___________ 
Signature of the Person Conducting the  
 
 
 
Date 
 
Consent Discussion   
 
 
 
 
 
 
 
CONSENT FOR SUBJECTS WHO CANNOT READ   
 
The study subject has indicated that he/she is unable to read.   The consent document has 
been read to the subject by a member of the study staff, discussed with the subject by a 
member of the study staff, and the subject has been given an opportunity to ask questions 
of the study staff.    
 
______________________________ 
Printed Name of Impartial Witness  
 
______________________________ 
 
 
__________ 
Signature of Impartial Witness*  
 
 
 
 Date  
 
*Impartial Witness:  A person, who is independent of the trial, who cannot be unfairly influenced by people involved 
with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative 
cannot read, and who reads the informed consent and any other written information supplied to the subject. Guidance 
for Industry E6 Good Clinical Practice:  Consolidated Guidance  

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AUTHORIZATION TO USE AND DISCLOSE 
PROTECTED HEALTH INFORMATION 
 
 
During your participation in this research study, the study doctor Jesse Hade, 
M.D., Janelle Luk, M.D., Dr Edward Nejat, M.D. or another designated physician 
and study staff will collect or create personal health information about you (for example, 
medical histories and results of any tests, examinations, or procedures you undergo while 
in the study) and record it on study documents. The study doctor will keep this personal 
health information in your study-related records (that we will refer to as "your study 
records"). In addition, the study doctor may obtain and include in your records, 
information regarding your past, present, and/or future physical or mental health and/or 
condition. Your study doctor may ask you to sign a separate authorization to obtain some 
or all of your medical records from your doctor. Your study records may include other 
personal information (such as social security numbers, medical record numbers, date of 
birth, etc.), which could be used to identify you. Health information that could identify 
you is called Protected Health Information (or PHI). Other PHI that may be used includes 
laboratory data, photos, and images of ultrasounds, oocytes, and embryos. Information 
regarding test results for a resulting pregnancy including but not limited to birth date, 
gestational age of delivery, birth weight, size, complications of pregnancy and delivery, 
fetal malformations if it occurs, and method of delivery applies as well.  
 
 
Under federal law (the "Privacy Rule"), your PHI that is created or obtained 
during this research study cannot be "used" to conduct the research or "disclosed" (given 
to anyone) for research purposes without your permission. This permission is called an 
"Authorization."  Therefore, you may not participate in this study unless you give your 
permission to use and disclose your PHI by signing this Authorization. By signing, you 
are agreeing to allow the study doctor Jesse Hade, M.D. or another GNF physician and 
staff to use your PHI to conduct this study.  
 
By signing this Authorization, you also are agreeing to allow the study doctor Jesse Hade, 
M.D. or another GNF physician to disclose PHI as described below: 
 
• 
The sponsor of this study and anyone working on behalf of the sponsor to conduct 
this study (referred to as "the sponsor"). The sponsor will analyze and evaluate the 
PHI and may use it to develop new tests, procedures, and commercial products. The 
study staff will assign a code number and/or letters to participant records, which 
means that they will not ordinarily be identified in the records sent to the sponsor. 
The sponsor may, however, look at complete study records that identify participants. 
In addition, the sponsor may visit the study site to oversee the way the study is being 
conducted and may review participants' PHI during these visits to make sure the 
information is correct.  
• 
The Institutional Review Board ("IRB") may have access to your PHI in relation to its 
responsibilities as an Institutional Review Board. 

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Page 24 of 25 
Patient Initials: __________ 
• 
Your medical insurance company or other third-party payer and legal boards and 
other legal representatives of your choosing may request access to your PHI. 
 
The study doctor or sponsor may disclose your PHI to the United States Food and Drug 
Administration ("FDA") or similar regulatory agencies in the United States and/or 
foreign countries. 
 
These disclosures also help ensure that the information related to the research is available 
to all parties who may need it for research purposes. 
 
Except for the disclosures described above, your PHI will not be shared with others 
unless required by law. If your PHI is given to the parties listed above and/or to others 
who are not required to comply with the federal law, your PHI will no longer be 
protected by this law and could possibly be used or disclosed in ways other than those 
listed here.  
 
You have a right to see and make copies of your PHI. You are agreeing, however, by 
signing this document, not to see or copy some or all of your PHI until the sponsor has 
completed all work related to this study. At that time, you may ask to see your complete 
records. 
 
This Authorization will expire 50 years from the date you sign it unless you revoke 
(cancel or withdraw) it sooner.  
 
You have a right to revoke your Authorization at any time. If you revoke it, your PHI will 
no longer be used for this study, except to the extent the parties to the research have 
already taken action based upon your Authorization or need the information to complete 
analysis and reports for this research. To revoke your Authorization, you must write to 
the study doctor Jesse Hade, M.D. or another designated GNF physician, stating that 
you are revoking your Authorization to Use and Disclose Protected Health Information. 
If you revoke this Authorization, you will not be allowed to continue to be in this study.  
 
You will receive a copy of this Authorization after you have signed it. 
 
____________________________________ 
 
____ 
Signature of Subject 
 
 
 
 
 
Date 
 
____________________________________ 
Printed Name of Subject 
 
____________________________________ 
 
_____ 
Signature of the Person Obtaining the  
 
 
Date 
Authorization 
 
 

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Patient Initials: __________ 
 
_____________________________________ 
Printed Name of the Person Obtaining the  
Authorization 
 
 
FOR SUBJECTS WHO CANNOT READ   
 
The study subject has indicated that he/she is unable to read.  This Authorization 
document has been read to the subject by a member of the study staff, discussed with the 
subject by a member of the study staff, and the subject has been given an opportunity to 
ask questions of the study staff.    
 
______________________________ 
Printed Name of Impartial Witness  
 
 
______________________________  
 
__________ 
Signature of Impartial Witness*  
 
 
 
Date  
 
*Impartial Witness:  A person, who is independent of the trial, who cannot be unfairly influenced by people involved 
with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative 
cannot read, and who reads the informed consent and any other written information supplied to the subject. Guidance 
for Industry E6 Good Clinical Practice:  Consolidated Guidance  
 
i Conde Montero E, Fernandez Santos ME, Suarez Fernandez R: Platelet-rich plasma: applications in 
dermatology. Actas Dermosifiliogr 2015; 106: 104–111. 
ii Sommeling CE, Heyneman A, Hoeksema H, Verbelen J, Stillaert FB, Monstrey S: The use of platelet-rich 
plasma in plastic surgery: a systematic review. J Plast Reconstr Aesthet Surg 2013;66:301–311. 
iii Sills E, Rickers N, Li X, Palermo G. First data on in vitro fertilization and blastocyst formation after 
intraovarian injection of calcium gluconate-activated autologous platelet rich plasma. Gynecol Endocrinol. 
2018;34:756–60. 
iv Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund, G, Gianaroli L, et al. ESHRE working 
group on Poor Ovarian Response Definition. ESHRE consensus on the definition of ‘poor response’ to 
ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011;26:1616-24.