Investigational Oocyte Cryopreservation for Medical and Non Medical Indications
Phase: NA
Conditions: Infertility, Female, Deferred Childbearing
Sponsor: University of Illinois at Chicago

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Investigational Oocyte Cryopreservation for Medical and Non Medical Indications 
 
Principal Investigator 
Sana Salih, MD, MS 
University of Illinois at Chicago 
College of Medicine 
Department of Obstetrics and Gynecology 
salih@uic.edu 
312-355-3245 
 
 
Co-Investigators 
 
Nicola Winston, PhD 
University of Illinois at Chicago 
College of Medicine 
Department of Obstetrics and Gynecology 
nicolaw@uic.edu 
312-996-1773 
 
Michelle Fierro, BS 
University of Illinois at Chicago 
College of Medicine 
Embryologist, Department of Obstetrics and Gynecology 
mpucci1@uic.edu 
312-355-2706 
 
Frank Gonzalez, MD 
University of Illinois at Chicago 
College of Medicine 
Department of Obstetrics and Gynecology 
frgz12@uic.edu 
312-413-1984 
 
 
 
 
Study site:  University of Illinois Hospital & Health Sciences System – IVF Program in 
the Fertility Center (Outpatient Care Center, Suite 4A) 
 
 
 
 
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Date: 03/28/2022 
 

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Introduction 
 
Oocyte cryopreservation is a procedure offered currently by commercial facilities 
throughout the United States not only to cancer patients, but also to healthy women who 
wish to delay childbearing. Nevertheless, little follow-up data regarding the actual 
efficacy of this approach or the health of infants born following its use are available. To 
this end, the Ethics Committees of the American Society for Reproductive Medicine 
(ASRM; 2005) and Committee on Gynecologic Practice of the American College of 
Obstetricians and Gynecologists (ACOG; 2008) have both stated that while oocyte 
cryopreservation holds significant promise for fertility preservation, the procedure is still 
considered investigational and may only be offered with appropriate informed consent in 
a research setting and with the oversight of an institutional review board (IRB). 
 
The technical ability to cryopreserve gametes for future use provides important options 
for patients who wish to preserve their childbearing potential before facing therapy that 
is anticipated to result in the termination of gonadal function.  Most commonly, the 
desire for fertility preservation is seen in individuals who are about to undergo either 
chemotherapy or radiation therapy for various malignancies.  It has been possible to 
successfully freeze and thaw semen samples for many years; more recently, it has 
become feasible for couples to cryopreserve zygotes. Until very recently, however, for a 
variety of technical reasons, successful cryopreservation of mature oocytes has been 
problematic. Mature oocytes can be retrieved following hormonal stimulation identical to 
that used for in vitro fertilization and cryopreservation (Chen, 1986). Historically, post-thaw 
recovery of cryopreserved oocytes with subsequent fertilization and embryo transfer led to 
disappointing results (Porcu et al., 1999; Marina & Marina, 2003).  An assessment of egg 
quality and an understanding on how it may be impacted based on demographics such as 
age and various chemotherapeutics is an essential next step in offering the technology. 
Hundreds of babies have now been born worldwide following oocyte 
cryopreservation with reportedly no apparent increase in birth anomalies and the 
technique holds clinical and practical promise for many patient populations (Noyes, 2009). 
Consequently, it is appropriate to offer this emerging technology as an investigational 
procedure with appropriate informed consent, in a research setting and with the 
oversight of an institutional review board (IRB). Patients who are candidates for this 
investigational procedure are young women at risk of potential fertility loss due to 
medical reasons, such as chronic disease and / or treatments using radiation or 
chemotherapy, or a genetic disposition to infertility, and non medical reasons; 
unforeseen necessity to halt an IVF treatment cycle (adverse reactions to hormonal 
hyperstimulation, inappropriate endometrial receptivity or inability of the partner to 
produce a viable sperm sample), patients concerned with ethical and legal issues 
related to embryo cryopreservation, and women who fear their childbearing may be 
deferred to an advanced age.  
 
We believe that the process of undergoing a fertility preservation consultation and/or 
undergoing an oocyte harvest in itself has a potential therapeutic benefit.  Focusing on, 
“after” a patient’s cancer diagnosis has been suggested to have a positive effect on a 

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patient’s psychosocial state.  We wish to explore this theory with implementation of a 
follow-up interview and the validated Ferti-Qol questionnaire to assess a patient’s 
quality of life. (Boivin et al, 2011) We also plan to assess egg quality in all of our 
patients 
to 
determine 
the 
impact 
of 
patient 
demographics 
and 
various 
chemotherapeutics. 
 
 
Purpose & Objective 
 
Purpose: This investigational study will permit patients to cryopreserve their oocytes, 
after first obtaining full written informed consent, for the purpose of potential future use 
under the oversight of the institutional review board, as specified by ASRM and ACOG 
current guidelines. The data obtained will also contribute to the knowledge base 
surrounding quality of life issues and fertility preservation in general, and oocyte 
cryopreservation in particular.  
 
Objective: To determine the long term benefits, in particular impact on patient quality of 
life and clinical outcomes associated with the use of oocyte cryopreservation as an 
investigational option for women who wish to preserve their fertility, to  assess egg 
quality and determine how patient demographics and various chemotherapeutics may 
affect it. 
 
Hypothesis: Oocyte cryopreservation, which is currently investigational and requires IRB 
oversight, may be an effective and safe method of fertility preservation for women who 
may be facing the loss of future fertility due to medical or non medical reasons, with 
resulting future successful pregnancies. The process of fertility preservation will have a 
perceived improvement on patient quality of life. Egg quality will be impacted by patient 
age and alkylating chemotherapy but not other agents or demographic characteristics. 
 
Rationale: Fertility preservation is an important quality of life issue for cancer patients. 
For instance, when considering the long term sequelae of cancer therapy, infertility 
surfaces as a primary concern, particularly among female survivors (Zeltzer, 1993). 
Unlike other late effects of cancer treatment, such as complications in cardiovascular or 
liver function, female infertility has biological and psychosocial implications that cannot 
be narrowly defined, nor easily addressed given the number of ethical and legal 
questions surrounding fertility preservation (Patrizio et al., 2005). Women may also be 
at risk of experiencing fertility loss due to many non-oncological conditions such as 
endometriosis, diminished ovarian reserve / premature ovarian failure, chromosomal 
abnormalities (for example Turner’s syndrome) and autoimmune disorders that may 
require treatment with gonadotoxic agents which can lead to premature ovarian failure. 
Women whose childbearing may be delayed may also desire fertility preservation. 
Finally, patients who are undergoing in vitro fertilization to treat infertility may 
experience situations that result in a halt in their treatment cycle due to problems such 
as adverse reactions to hormonal hyperstimulation, inappropriate endometrial 
receptivity or inability of the partner to produce a viable sperm sample on the day of 
their egg retrieval (e.g. partner unexpectedly out of town, unable to collect sample), or 

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who do not wish to inseminate all the oocytes collected that may result in the production 
of an excessive number of embryos, or who wish not to cryopreserve embryos for 
ethical reasons can utilize oocyte cryopreservation so that their retrieved oocytes are 
not wasted. 
 
Chen reported the first successful attempt at cryopreserving and thawing a human 
oocyte – a twin pregnancy resulted after in vitro fertilization and embryo transfer (Chen, 
1986). Progress in the field moved slowly for the next decade after murine data 
suggested that cryopreserved oocytes showed higher levels of chromosomal anomalies 
when compared with fresh oocytes (Johnson & Pickering, 1987). However, work in the 
early 1990s by Gook et al. demonstrated that cryopreservation was not as detrimental 
as originally thought, leading to renewed research interest in human oocyte 
cryopreservation (Gook et al., 1994). By 2004, 100 human babies had been born from 
cryopreserved oocytes.  However, these infants were produced with great inefficiency 
(Stachecki & Cohen, 2004). For instance, Marina & Marina (2003) reported a 4% live 
birth rate from 99 frozen oocytes and results with larger sample sizes were even less 
impressive; 16 pregnancies from 1502 thawed oocytes (Porcu et al., 1999).  
Breakthroughs made by Italian researchers in optimizing freezing and thawing methods 
greatly improved pregnancy rates with mature human oocytes yielding pregnancy rates 
per thaw cycle of 10% which compares favorably with the natural fecundity rate of 20% 
per cycle (Coticchio et al., 2006; Paynter et al., 2005; Fabbri et al., 2001; Bianchi et al., 
2007; Borini et al., 2004; Borini et al., 2006; Grifo and Noyes, 2009; Nagy et al., 2009). 
However, these results are still well below the pregnancy rates for fresh IVF cycles in 
women under the age of 37 years (45-55% live-birth rate).  
 
There is little doubt that oocyte cryopreservation offers a reasonable fertility 
preservation option for cancer patients. However, it is imperative that follow-up data 
regarding the actual efficacy of this approach and the health of infants born following its 
use be prospectively generated, notwithstanding the difficulties inherent in the time 
frame over which patients might need to be followed.   
 
The ASRM and ACOG practice guidelines stating that oocyte cryopreservation is still 
considered investigational and may only be offered with appropriate informed consent in 
a research setting with IRB oversight necessitate more rigorous investigation into the 
methods and consequences of oocyte cryopreservation in order for it to evolve from an 
experimental to a standard procedure,. To this end, this protocol has been designed to 
identify suitable candidates for oocyte cryopreservation and to systematically follow 
them in order to assess the long term benefits and outcomes associated with its use.  
During our investigation we will explore egg quality and quality of life measures. 
 
Lastly, the implementation of fertility preservation counseling and obtaining of oocytes 
for future use is believed to have a positive impact on a cancer patient’s quality of life. 
We will obtain a structured fertility focused quality of life questionnaire and survey to 
assess one year after harvest the impact of the process. We will compare cancer 
patients to those patients undergoing oocyte cryopreservation for non-medical reasons. 
 

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Study Design 
 
Research Design & Methodology: We will conduct a prospective study to assess the 
long term benefits and outcomes of the existing oocyte cryopreservation methods for 
fertility preservation in women with a potential medical or non medical risk of loss of 
fertility. Women wishing to preserve their oocytes using cryopreservation will be 
informed of the risk and limitations of the procedures involved in ovarian 
hyperstimulation, oocyte recovery, cryopreservation and subsequent viability after 
warming. Women who consent to the procedure will undergo standard controlled 
ovarian hyperstimulation (COH) and oocyte retrieval procedures currently in use for IVF. 
Following harvest all eggs obtained will be evaluated for degree of fragmentation and 
maturation status. The oocytes will be cryopreserved using kits of media and devices 
currently approved for use in the vitrification of fertilized eggs and embryos, and the 
cryopreserved oocytes will be stored for future patient use in a long term storage facility 
in Minnesota (Reprotech Ltd.). Patients with stored oocytes will be contacted annually to 
determine the outcome of any oocyte warming procedures (oocyte thawing, fertilization 
and embryo transfer). 
We will obtain a structured fertility focused quality of life questionnaire (FertiQol) and 
survey to assess one year after harvest the impact of the process. We will compare 
cancer patients to those patients undergoing oocyte cryopreservation for non-medical 
reasons. FertiQol is scored based on the standards of the assessment tool in a 
quantitative manner. The structured interview will be assessed in a qualitative manner. 
Duration: Until the completion of our investigational study and the patient outcome 
follow-up one year following oocyte harvest. 
 
Location: Female patients will be identified and consented and all study procedures will 
be conducted through the Division of Reproductive Endocrinology and Infertility, 
Department of Obstetrics and Gynecology, University of Illinois at Chicago (UIC).   
 
 
Participant Selection and Enrollment 
 
This study will enroll up to 50 women of reproductive age over 5 years at UIC, in three 
different categories: 
 
1. Women of reproductive age who are diagnosed with cancer or any disease 
whose treatment or its progression may impair their reproductive potential.   
2. Women undergoing standard In Vitro Fertilization to treat infertility who 
experience unforeseen events that halt the treatment cycle, such as adverse 
reactions to hormonal hyperstimulation, inappropriate endometrial receptivity, 
inability of the partner to provide a semen sample on the day of the egg retrieval 
or who are unable to consent to freezing of embryos so that the eggs can be 
cryopreserved and not discarded, as is standard procedure currently.(e.g., failed 
testicular sperm aspirations, inability to collect or unexpected need to be out of 
town or patients with ethical objections to freezing of embryos). 

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3. Women seeking oocyte cryopreservation for non medical reasons such as 
deferred childbearing.  
 
Women seeking fertility preservation are referred for a comprehensive consultation with 
a Reproductive Endocrinologist to discuss the range of treatment options available to 
her. Only patients who choose oocyte cryopreservation as their method of fertility 
preservation will be enrolled in the study. 
 
Informed Consent Procedure: Participation in this study is entirely voluntary.  Choosing 
to not participate will not impact the care received at this institution.  Following selection 
and counseling as outlined above, all subjects will be required to provide informed 
consent for participation in the study.  All potential subjects will be informed of the risks 
of the procedure. Information about oocyte retrieval and cryopreservation will be 
provided and the experimental nature of oocyte cryopreservation will be emphasized.  
They will be informed of the extent to which they may benefit from the study. The 
subject will be granted time to read the informed consent document, and all questions 
will be answered to her satisfaction. 
 
Inclusion Criteria:  
• Women aged >18 and <  40years. 
• Women able to defer definitive cancer therapy for 21 to 30 days. 
• Women diagnosed with cancer or any disease whose treatment or its progression 
may impair their reproductive potential (this would include but not be limited to 
cancer patients requiring treatment with chemotherapy or radiation, patients with 
rheumatologic diseases such as lupus, rheumatoid arthritis and ulcerative colitis and 
patients with genetic predisposition to cancers. 
• Women undergoing standard In Vitro Fertilization to treat infertility who experience 
unforeseen events that halts the treatment cycle. 
• Women seeking oocyte cryopreservation for non medical reasons, such as deferred 
childbearing. 
• Women who are carriers of BRCA mutations predisposing them to cancer. 
• Otherwise healthy females. 
• Ability and willingness to comply with study protocol 
• Informed written consent, prior to any study-related procedure not part of normal 
care, with the understanding that the subject may withdraw consent at any time 
without prejudice to their future medical care 
 
Exclusion Criteria: 
• Current pregnancy 
• Serum FSH > 10 mIU/ml for patients having egg freezing for a medical indication  
• Serum FSH > 10 mIU/ml for patients having egg freezing for social reasons 
• Women who upon undergoing psychological assessment are found to be unable 
to provide informed consent or are expected to be unable to cope with the rigor 
of the study) 
• Patients with extensive disease whose therapy is deemed palliative by the 
medical oncologist. 

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Compensation to Subjects for Participation:   
 
Subjects will not receive compensation for participation in the study. No direct 
reimbursement will be made to the subjects or to their families. All costs will be billed to 
the subject or subject’s insurance. All non-covered services are the subject’s 
responsibility.   
 
In the event of injury or illness resulting from the research procedures, medical 
treatment for injuries or illness is available through the University of Illinois at Chicago 
Medical Center.  Payment for this treatment will be the subject’s responsibility. 
 
 
Study Procedures 
 
Following selection, potential subjects must be informed fully about the process involved 
and clinical outcomes that can be reasonably expected. Counseling by a qualified 
mental health professional will also be required. After obtaining informed consent, 
enrolled subjects will participate in the following:  
 
Standard Oocyte Harvesting Procedure: Subjects will undergo controlled ovarian 
hyperstimulation according to established clinical protocols utilized in the In Vitro 
Fertilization Program at UIC.  Briefly, they will be treated with variable dosages of 
injectable gonadotrophins over a period of 8 to 12 days. Response will be monitored 
using vaginal ultrasound and serum estradiol levels. When appropriate follicle 
maturation has been achieved, a single dose of human chorionic gonadotropin (hCG) 
will be administered to induce final oocyte maturation. Thirty-six hours after hCG 
administration, the subject will undergo standard transvaginal oocyte retrieval under 
ultrasound guidance. The procedure takes approximately 20 minutes and is carried out 
under conscious sedation with Fentanyl and Versed. The oocytes are immediately 
handed off to the embryology technicians in the IVF laboratory.  
 
Investigational Oocyte Cryopreservation:  Oocyte cryopreservation will be carried out 
using the technique of vitrification, which has resulted in high oocyte survival, 
fertilization, pregnancy and implantation rates in case series reported in the literature 
(Oktay et al, 2006; Fadini et al, 2009; Cao et al, 2009, Smith et al, 2010). Oocytes will be 
cryopreserved using modifications of vitrification techniques described by Cao et al, 2009, 
Griffo and Noyes, 2009, Nagy et al, 2009 and Smith et al, 2010. Prior to 
cryopreservation, when eggs are being evaluated by the embryologist; 
fragmentation score and maturation status will be formally evaluated and recorded. 
 
Standard Oocyte Storage: All cryopreserved oocytes will be transferred to Reprotech, Ltd. 
(RTL) in St. Paul, MN for storage and subsequent release. Reprotech, Ltd. is an FDA-
compliant and American Association of Tissue Banks (AATB)-accredited long term storage 
facility for reproductive tissues. Patients will execute a separate storage agreement with 
Reprotech, Ltd which defines the length of storage, shipping requirements, infectious 

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disease screening and testing and disposition of the tissues in the event of the patient’s 
death. 
 
Standard Infectious Disease Screening and Testing: Banking and subsequent use of 
oocytes is regulated by the Food and Drug Administration (FDA). In order to be 
prepared for any future requirement, patients will be tested and screened for a number 
of infectious diseases prior to banking their oocytes. The screening and testing that will 
be performed are the same as would be performed on an anonymous reproductive 
tissue donor and include a physical examination and a standard questionnaire for 
reproductive tissue donors. The testing that will be performed is mandated for donors of 
reproductive tissues and must be performed within 30 days of oocyte retrieval. The 
testing will be performed by LifeSource Blood Services, IL and Viromed Laboratories, 
MN. This way, the tissue could potentially be used by the patient herself, but it could 
also be suitable for future use in another individual (such as a gestational surrogate) if 
indicated by the patient’s medical condition (e.g., IVF with embryo transfer to a 
gestational carrier for a patient without a uterus). In addition, a sample of the patient’s 
blood (plasma) will be stored with the oocytes at Reprotech Ltd., St. Paul, MN, to permit 
any future testing requirements under federal tissue banking regulations. In spite of 
storing blood plasma, it is still possible that federal regulations may change and 
therefore, it may not be possible to perform the appropriate testing to permit 
heterologous use of the tissue in the future..  
 
Establishment and Maintenance of the Outcome Data: Subjects in the study will agree 
to maintain contact with the investigators, as outlined in the consent form.  
 
Quality of Life Assessment 
Specifically, they will agree to notify the investigators of any changes in their contact 
information. Study participants will be contacted on an annual basis using the 
“Investigational Oocyte Cropreservation Follow-up Call Script” to determine any 
subsequent attempts to utilize the stored oocytes for the purpose of initiating a 
pregnancy, along with the outcome of the attempt. An additional follow up email script 
will also be added to this research.  In addition, patients will complete the Ferti-Qol 
questionnaire at the one year time point. All other dispositions of the oocytes will also be 
recorded. Individual files will be kept active until all oocytes have been utilized, disposed 
of in some other way, or ten years following storage, whichever comes first. Patients will 
be assigned a research number and data will be de-identified. All de-identified data and 
the master code list will be stored in a locked file cabinet in a locked office and in a 
password-protected computer in a locked office by the PI and only the co-investigators 
and the PI will have access to the data. 
 
The subject’s participation in this study may involve the following risks;  
 
Standard Ovarian Stimulation: The ovarian stimulation step often causes a sense of 
fullness or bloating, which usually goes away within a few days after the retrieval. In 
about 1% cases, patients will develop ovarian hyperstimulation syndrome (OHSS) a 
serious complication resulting in the accumulation of fluid in the abdominal cavity. This 

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complication is self-limited, but severe cases may require several days of hospitalization 
for fluid management. In patients facing a cancer diagnosis, the use of fertility 
medication will cause a significant increase in two ovarian hormones, estrogen and 
progesterone, which could potentially worsen the prognosis for the cancer. However, in 
the case of most cancers the use of fertility drugs does not appear to worsen the 
chances for cure. Nevertheless, patients will need to discuss with their medical 
oncologist the pro’s and con’s of fertility drug use prior to undertaking oocyte 
cyropreservation.    
 
Standard Oocyte Retrieval: Risks of oocyte retrieval include infection, damage to 
internal organs, or bleeding problems as a result of the insertion or manipulation of the 
needle used to recover the oocytes. The chance hospitalization or more extensive 
surgery for the management of such complications is about 1/1000. Such 
complication(s) may necessitate a delay in further chemotherapy or radiation therapy 
treatments for the subject’s disease. Minor complications, such as temporary abdominal 
pain or cramping, are common. 
 
Standard Conscious Sedation: The sedation step is very safe and rarely results in 
complications. In unusual cases, sedation may result in cessation of breathing efforts 
(apnea), and medications to counteract the sedating drugs may need to be 
administered. This complication occurs in about 1/1000 cases.   
 
Investigational Cryopreservation: Although care will be taken, damage to the retrieved 
oocytes may occur during any part of the cryopreservation (freezing) or storage 
process. The effects of cryopreservation and long term storage on human oocytes are 
not known and possible damage to the oocytes may occur. The risk of birth defect(s) 
and/or genetic damage to any child who may be born following such a procedure is also 
unknown. Thousands of children have been born worldwide from frozen embryos and 
there has been no report of increased risk of birth defects in these children. Hundreds of 
children have been born worldwide from the use of frozen eggs and there does not 
appear to be an increased incidence of birth defects but more data must be collected. 
The oocytes removed may not yield usable eggs, or pregnancy may not result when the 
eggs are ultimately used. Oocytes could be lost or made unusable due to equipment 
failure, or unforeseeable natural disasters beyond the control of this program. 
 
Emotional Risks: Participation in this study may subject the participant to additional 
emotional risks beyond those directly related to her planned treatment. 
 
Risk/Benefit Ratio: The oocytes stored for the patients’ own use can eventually be used 
successfully to initiate a pregnancy. Participation in this research study may indirectly 
help other women who could benefit from information about the efficacy and safety of 
oocyte cryopreservation, long term oocyte storage and use of frozen oocytes. The risks 
are small in comparison to the benefit and are the same as those encountered by all 
infertility patients undergoing routine in vitro fertilization (IVF) procedures in our Division. 
  
Alternatives: The subject has the alternative to choose not to participate in this study.  

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If the subject is undergoing medical cancer treatments she may receive chemotherapy 
or radiation therapy without undergoing retrieval and storage of oocytes. If she has a 
partner, she has the option of undergoing treatment with in vitro fertilization in order to 
cryopreserve (freeze) embryos for future use. She also has the alternative of 
undergoing therapy GnRH agonists prior to your cancer treatment.  There is some 
evidence that such treatment reduces the risk of damage to the ovaries by either 
chemotherapy or radiation therapy. This treatment is still considered experimental. It is 
not approved for this use at this time. She also has the option of undergoing ovarian 
tissue cryopreservation which is also an experimental procedure. 
   
If the subject is undergoing IVF, has had eggs retrieved but the sperm sample needed 
to fertilize the oocytes is not available or she is unable to give consent for freezing of 
embryos, the eggs can be discarded.  
 
If the subject is freezing eggs for social reasons, she can decide not to do that. 
 
Protection of Subjects: The principal investigator and co-investigators will only access 
data collected as part of this study. All information will be kept confidential and will not 
be shared except as may be required by law. No information by which the subject can 
be identified will be released or published in connection with this study. All data will be 
stored in a confidential database.   
 
Information will only be used for the purpose of this study. The following groups of 
people may have access to the research information: the research team, the Hospital’s 
ethics committee (Institutional Review Board), and the Food and Drug Administration 
and the Center for Disease Control as required by federal law. 
 
Data Safety & Monitoring: The principal investigator and co-investigators will monitor the 
subject records every 6 months for completeness and to determine whether any new 
information has become available, which may impact continuation of this study. Any 
adverse events or complaints will be reported to the IRB with the appropriate notification 
form.   
 
Criteria for Terminating the Study: Once the risk/benefit ratio of the protocol becomes 
unfavorable, where the subject is exposed to greater harm than potential benefit, the 
study will be terminated.  Notice of study termination will be submitted to the University 
of Illinois at Chicago’s IRB.  
 
Procedures for Reporting Deviations from the Original Plan: Any deviations from the 
original protocol that take place during the course of the study will be reported in a 
timely fashion to University of Illinois at Chicago’s IRB in the form of a revision or 
safety/other submission.   
 
 
 
 

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Conclusion 
 
Fertility preservation ranks as one of the greatest concerns for women diagnosed with 
cancer as well as those fearing loss of fertility due to deferred childbearing. Therefore, 
establishing the effectiveness and safety of oocyte cryopreservation as a fertility 
preservation option would greatly impact the reproductive destinies of women 
undergoing fertility-threatening treatment. The psychosocial impacts of fertility 
preservation and oocyte harvest are not well established. At the conclusion of the study, 
we hope to have sufficient data to assess the long term benefits and outcomes of 
oocyte cryopreservation, including information regarding the future use of cryopreserved 
oocytes, their survival and viability, pregnancy and live birth outcomes, as well as 
quality of life assessment, so as to confidently offer the procedure as a safe and 
effective method of fertility preservation.  We also hope to build on the current 
understanding of the factors that impact egg quality; another key aspect of success and 
thus patient consultation. 
 
Anticipated Results & Potential Pitfalls: It is anticipated that oocyte cryopreservation will 
provide a scientifically sound fertility preservation option for cancer patients and for 
women who wish to delay child bearing. While the cryopreservation procedure is still 
experimental, early findings have demonstrated promising results. The findings from this 
study will contribute to the existing knowledge base by providing valuable evidence 
about how to perfect the cryopreservation process and increase pregnancy rates in 
women whose oocytes have been frozen and thawed and to document the long term 
outcomes from the use of these oocytes (pregnancy rates and rate of birth defects).   
 
 
 
References 
 
American College of Obstetrics and Gynecologists. (2008) ACOG Committee Opinion. 
Ovarian tissue and oocyte cryopreservation.  Obstet Gynecol; 111(405):1255-56. 
 
American Society for Reproductive Medicine. (2005) Fertility preservation and 
reproduction in cancer patients. Fertil Steril; 83:1622-28.   
 
Bianchi V, Coticchio G, Distratis V, DiGuisto N, Flamigni C, & Borini A. (2007) 
Differential sucrose concentration during dehydration (0.2 mol/l) and rehydration (0.3 
mol/l) increases the implantation rate of frozen human oocytes. RBM OnLine; 14:64-71. 
 
Bagchi A, Woods EJ, et al. (2008) Cryopreservation and vitrification: recent advances in 
fertility preservation technologies. Expert Review of Medical Devices; 5:359-70. 
 
Borini A, Bonu M, Coticchio G, Bianchi V, Cattoli M, & Flamigni C. (2004) Pregnancies 
and births after oocyte cryopreservation. Fertil Steril; 82:601-5. 
 

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Version 13 
 
 
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Page 12 of 13
Borini A, Sciajno R, Bianchi V, Sereni E, Flamigni C, & Coticchio G. (2006) Clinical 
outcome of oocyte cryopreservation after slow cooling with a protocol utilizing a high 
sucrose concentration. Hum Reprod; 21:512-17. 
 
Cao Y-X, Xing Q, Li L, et al. (2009) Comparison of survival and embryonic development 
in human oocytes Cryopreserved by slow-freezing and vitrification. Fertil Steril; 92:1306-
11. 
 
Chen C. (1986) Pregnancy after human oocyte cryopreservation. Lancet; 1:884-886. 
 
Chian RC, Huang JY, et al. (2009) Obstetric outcomes following vitrification of in vitro 
and in vivo matured oocytes. Fertil Steril; 91:2391-8. 
 
Coticchio G, DeSantis L, Rossi G, Borini A, Albertini D, Scaravelli G, et al. (2006) 
Sucrose concentration influences the rate of human oocytes with normal spindle and 
chromosome configurations after slow-cooling cryopreservation. Hum Reprod; 21:1771-
76. 
 
Fabbri R, Porcu E, Marsella T, Rocchetta G, Venturoli S, & Flamigni C. (2001) Human 
oocyte 
cryopreservation: 
New 
perspectives 
regarding 
oocyte 
survival. 
Hum 
Reprod;16:411-16.  
 
Fadini R, Brambillasca F, Renzini MM et al. (2009) Human oocyte cryopreservation: 
comparison between slow and ultrarapid methods. RBM Online; 19:171-80. 
 
Gook D, et al. (1994) Fertilization of human oocytes following cryopreservation: Normal 
karyotypes and absence of stray chromosomes. Hum Reprod; 9:684-91. 
 
Grifo JA, Noyes N (2009) Delivery rate using Cryopreserved oocytes is comparable to 
conventionsl in vitro fertilization using fresh oocytes: potential fertility preservation for 
female cancer patients. Fertil Steril; 92:In press. 
 
Johnson M. & Pickering S. (1987) The effect of dimethylsulphoxide on the microtubular 
system of the mouse oocyte. Development; 100:313-24. 
 
Kuwayama M. (2007) Highly efficient vitrification for cryopreservation of human oocytes 
and embryos: The Cryotop method. Theriogenology; 67:73-80. 
 
Marina F. & Marina S. (2003) Comments on oocyte cryopreservation. RBM Online; 
6:401-2. 
 
Nagy ZP, Chang CC, Shapiro DB, et al. (2009) Clinical evaluation of the efficiency of an 
oocyte donation program using egg cryo-banking. Fertil Steril; 92:520-26. 
 
Noyes N. (2009) Over 900 oocyte cryopreservation babies born with no apparent 
increase in congenital anomalies. RBM Online; 18:769-76. 

Investigational Oocyte Cryopreservation for Medical and Non Medical Indications  
Version 13 
 
 
03/28/2022 
Page 13 of 13
 
Oktay K, Cil AP, Bang H (2006) Efficiency of oocyte cryopreservation: a meta-analysis. 
Fertil Steril; 86:70-80. 
 
Patrizio P, Butts S, & Caplan A. (2005) Ovarian tissue preservation and future fertility: 
Emerging technologies and ethical considerations. Journal of the National Cancer 
Institute Monograph; 34:107-110. 
 
Paynter S, Borini A, Bianchi V, DeSantis L, Flamigni C, & Coticchio G. (2005) Volume 
changes of mature human oocytes on exposure to cryoprotectant solutions used in slow 
cooling procedures. Hum Reprod; 20:1194-1199. 
 
Porcu E, Fabbri R, Ciotti PM, et al. (1999) Cycles of human oocyte cryopreservation 
and intracytoplasmic sperm injection: Results of 112 cycles. Fertil Steril; 72 (Suppl. 
1):S2. 
 
Porcu E, Fabbri R, Damiano G, Fratto R, Giunchi S, Venturoli S. (2004) Oocyte 
cryopreservation in oncological patients.  European J Obstet Gynecol & Reprod Biol; 
113:S14-S16. 
 
Smith GD, Serafini PC, Fioravanti J, Yadid I, Coslovsky M, Hassun P, Alegretti JR, 
Motta EL. Fertil Steril (In Press). 
 
Stachecki J, Cohen J (2004) Cryopreservation and assisted human conception: An 
overview of oocyte cryopreservation. RBM OnLine; 9:152-63. 
 
Zeltzer LK. (1993) Cancer in adolescents and young adults: Psychosocial aspects in 
long-term survivors.  Cancer; 71 (Suppl):3463-68. 
 
Boivin, J., Takefman, J., & Braverman, A. (2011). The Fertility Quality of Life (FertiQoL) 
Tool: Development and general psychometric properties. Fertility and Sterility. 
 
Aarts JW, Huppelschoten AG, van Empel IW, Boivin J, Verhaak CM, Kremer JA, Nelen 
WL. How patient-centred care relates to patients' quality of life and distress: a study in 
427 women experiencing infertility. Hum Reprod. 2011 Nov 22.