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Removal of the ovary for cryopreservation is an investigational procedure. 100% of the tissue will be used for the participant's future use.

The ovarian tissue will be removed at a UK Healthcare facility and evaluated for gross disease by a pathologist, embryologist, andrologist or REI physician. The ovarian cortex will be dissected from the medulla and cut into strips in culture/holding media, washed to remove blood cells, and cryopreserved. Cryopreservation will be performed using modifications of the techniques described by Gosden et al. (1994) or will be vitrified using a modification of the techniques of Kuwayama et al., 2007.

Ovarian Cryopreservation

Lars Wagner, MD

The purpose of this research is to obtain ovarian tissue from female participants who will receive therapy which is expected to result in a loss or impairment of ovarian function and/or infertility and wish to preserve (freeze) ovarian tissue for the purpose of initiating a pregnancy in the future.

Removal of the ovary for cryopreservation is an investigational procedure. 100% of the tissue will be used for the participant's future use. There have been 86 pregnancies as a result of frozen ovarian tissue that has been re-implanted back into the pelvis and hormonal function has been restored in individuals for up to 7 years.

By doing this study, the investigators hope to learn of how to successfully freeze and thaw ovarian tissue in a manner that permits subsequent use by patients at some point in the future. Participation may also advance our knowledge of how to successfully mature follicles and oocytes (eggs) that are contained in these tissues which may help others in the future.

The research procedures will be conducted at the University of Kentucky (UK) Medical Center.

Participants in the study will provide ovarian tissue cryopreservation for their own personal use.

The duration of the study will be until the participant reaches age 41 years. Participants will be broken out into four categories:

Participants will have surgical removal of their ovarian tissue using the methods determined by their surgeon based on their medical/surgical diagnosis or treatment. Participants in one of the following categories will participant in the study:

1. Participants have elected to have one or both ovaries removed for the treatment or prevention of disease.
2. Participants who have elected to have surgery to remove all or part of one or both ovaries for medical reasons where cryopreservation of the remaining limited portions of normal ovarian cortex is the only option for fertility preservation at the time (except that ovarian cortex from the ovary that contains the mass will not be cryopreserved).
3. Participants who have elected to have surgery to remove all or part of one or both ovaries for medical reasons where cryopreservation of the remaining limited portions of normal ovarian cortex is the only option for fertility preservation at the time but who cannot or will not provide tissue to the research pool (except that ovarian cortex for the ovary that contains the mass will not be cryopreserved).
4. Participants who have elected to have one or part of one ovary removed, solely for the purpose of fertility preservation because they are not candidates for or choose not to use more mature fertility preservation technologies.

Participants undergoing elective removal of an ovary (category C above) will undergo a procedure called laparoscopy to remove the ovary. This surgery will be performed under general anesthesia and one ovary will be removed in total through an instrument channel employing standard techniques of operative laparoscopy. This surgical procedure is performed solely for fertility preservation but will potentially be coordinated with another procedure such as placement of a central line for future chemotherapy or laparotomy for another purpose. Although only one ovary will be removed, both of the participant's ovaries must appear normal for the procedure to be completed. The ovary to be removed will be chosen at the time of surgery based on appearance and ease of removal. After the surgery is complete, the participant will not have any further procedures except for a routine post-operative visit. A 0.5 cm cross section from the short axis of the ovary will be provided to the Department of Pathology for routine histological evaluation, and the remaining tissue will be processed for cryopreservation. If pathology finds evidence of cancer in the ovarian tissue provided at surgery, they may request that all of the participant's tissue (even tissue that has been frozen for their use) be returned to pathology for a more detailed examination. In this case, no tissue is available for the participant to use for fertility preservation purposes.

b. Cryopreservation: Ovarian tissue will be cryopreserved under the protocol originally established by the National Physicians Cooperative of the Oncofertility Consortium. The ovarian tissue will be removed at a UK or Norton Healthcare facility and evaluated for gross disease by a pathologist, embryologist, andrologist or a reproductive endocrinology and infertility (REI) physician. The ovarian cortex will be dissected from the medulla and cut into strips in culture/holding media, washed to remove blood cells, and cryopreserved. Cryopreservation will be performed using modifications of the techniques described by Gosden et al. (1994) or will be vitrified using a modification of the techniques of Kuwayama et al., 2007. The procedure for cryopreservation/vitrification may be modified as improvements become available.

The designated laboratory directors at UK responsible for the overall quality of the ovarian tissue cryopreservation.

c. Tissue storage: Cryopreserved participant tissues will be transferred to Reprotech, Ltd (RTL) in Roseville, Minnesota for storage and subsequent release. Reprotech, Ltd. is an FDA compliant and American Association of Tissue Banks accredited long term storage facility for reproductive tissues. Based on the extended periods of time that these tissues are likely to be stored Reprotech, Ltd. provides maximum flexibility for the participants involved. In this way, the participant can store tissues as long as they wish and ship them to a fertility treatment center of their choice at the time of use. The participant can determine how her own tissue will be used as technology changes and based on her unique circumstances. Reprotech, Ltd. does not perform fertility treatments and is not affiliated with any fertility center so there is no potential conflict of interest.

d. Infectious Disease Screening and Testing: Banking and subsequent use of ovarian tissue is regulated by the Food and Drug Administration (FDA). In order to comply with current tissue banking regulations and to be prepared for any future changes in regulations while these ovarian tissues are in storage, participants will be tested and screened for a number of infectious diseases prior to banking ovarian tissue.The testing will include but not be limited to testing for Hepatitis B and C and HIV. The testing that will be performed will be testing that is mandated for donors of leukocyte rich tissues and must be performed within 7 days of tissue procurement. In this way, the tissue could potentially be used by the participant herself and it could also be suitable for use in another individual (such as a surrogate) in the future if indicated by the participant's medical diagnosis.

If the ovarian tissue was vaginally removed during surgery the sites will also collect a vaginal swab from the participant for Gonorrhea and Chlamydia testing.

Please note that if the HIV screening test is positive, a confirmatory test will then be performed. Should the screening tests detect that participants are infected with HIV this information will be communicated confidentially to them through personal contact by a qualified professional. Participants will meet with a qualified professional who will provide HIV counseling.

There are risks associated with this study and those risks are outlined in the study informed consent document.

Benefit vs. Risk: There is no guarantee that participants will get any benefit from taking part in this study, although 86 babies have been born from transplanted frozen ovarian tissue. A females participation may provide her with a means to restore her fertility and reproductive hormonal function in the future as observed in previous reports. A females participation may also advance the investigator's understanding of how to successfully freeze and thaw ovarian tissue in a manner that permits subsequent use by the participant and other patients at some point in the future. A females participation may also advance the investigator's knowledge of how to successfully mature follicles and oocytes (eggs) that are contained in these tissues which may help the participant or others in the future. However, there is a significant possibility that there may be no direct benefit to the participant from her participation in this research study. Specifically, there is the possibility that ovarian cryopreservation will not result in successful pregnancy in the future.

There are alternatives to taking part in this study and those alternatives are addressed in the study informed consent document.

Costs: All expenses related to the research procedure will be covered by the research funds and include the oophorectomy, anesthesia, pathologist's fees and infectious disease testing.

Either the participant or their insurance company, Medicare or Medicaid will be responsible for the costs of all care and treatment that the participant would receive during this study that she would normally receive for her condition. These are costs that are considered medically reasonable and necessary and will be part of the care she receives if she does not take part in this study. This includes the confirmatory HIV testing and the follicle stimulating hormone (FSH) testing.

There are also costs associated with the handling, processing, shipping and storage of ovarian tissue. Those costs are outlined in the study informed consent document.

In the unlikely event that the participant is hurt or injured while participating in this study the medical costs related to their care and treatment will be their responsibility or submitted to their insurance.

Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis/Treatment

Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis Or Treatment Regimen

The investigator will describe the number of subjects who elect ovarian tissue cryopreservation (OTC) over a 1 year period of time to determine feasibility of OTC in oncology subjects receiving chemotherapy and radiation.

The investigator will describe the number of subjects who elect ovarian tissue cryopreservation (OTC) over a 5 year period of time to determine feasibility of OTC in oncology subjects receiving chemotherapy and radiation.

Vlad Radulescu

Professor

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Digestive System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Diabetes Mellitus

Chronic Disease

Fibrosis

Cystic Fibrosis

Pancreatic Diseases

Gastrointestinal Diseases

Lung Diseases

Respiratory Tract Diseases

Genetic Diseases, Inborn

Infant, Newborn, Diseases

Disease Attributes

Chronic Graft Versus Host Disease

The Medical Honors Program students will fill out the Patient Provider Orientation Scale (PPOS). MHP students will then interview a patient with a chronic or life limiting illness.

The patients will fill out the PPOS scale. The patient will then have an Interview performed by MHP student

Investigators are interested in the impact that our activity has on the students' patient-centeredness. Investigators will use the Patient-Practitioner Orientation Scale (PPOS), which will be completed by both the student and the patient prior to the encounter. Following the interview, the co-investigators will lead a discussion with the patient and student. Investigators will discuss differences in patient and student PPOS scores, and how each party felt the interview went. Investigators will examine if the patients feel the interview differed from typical interactions with health care providers, and how this made the patient feel. The students will describe what was learned from the patients story as well as try to explore reasons why providers may not always learn the patient's illness story.

Patient Provider Orientation Scale

The MHP students took a course called Medical Humanities in the fall of 2016. MHP students learned patient interviewing skills and the importance of gathering the patients "illness story". The students will conduct an interview with a patient with chronic illness, which will be focused on gather information about how the patients illness affects daily life as well as interactions with the health care system.

Interview performed by MHP student

Robert Lawrence, MD

A qualitative study assessing the impact of early narrative medicine practice on Medical Honors Program (MHP) students' attitudes regarding patient-centered interactions, through interviewing patients with chronic or life-limiting illnesses to obtain their illness stories.

MHP students will develop a patient narrative for the patients interviewed. These narratives will be edited by the patient, and, with the permission of the patients, may be published as a collection of stories.

Teach MHP Students about obtaining the illness story and narrative medicine. This will be done during the curriculum of the Medical Humanities class in the fall of 2016.

Recruit patients on units and floors in Shands University of Florida (UF) Health that may potentially have patients that will be good candidates for enrollment in the patient narratives. These may include pediatric hematology and oncology patients, adult hematology and oncology patients, patients with diabetes, organ transplant patients, cystic fibrosis patients, and rheumatologic disorder patients. Investigators will communicate with child life/social workers, as well as faculty medical providers on these inpatient services to help identify appropriate patients for referral and recruitment. These faculty members will obtain authorization from the patient for the investigators to approach the patient regarding recruitment.

Once a patient has been identified, a co-investigator will introduce the project to the patient, review examples of the types of questions to be asked by the MHP student, provide opportunity for questions, obtain informed consent, and provide them with the patient-practitioner orientation scale (PPOS) for completion.

A MHP student will meet with the co-investigator, fill out the PPOS, and then interview the patient. The co-investigator will be present for the interview, but the investigator would like the MHP student to conduct the interview. The interview will be voice recorded with encryption for later transcription.

Following the interview, a co-investigator will lead a discussion to determine patient and student observations/opinions about such conversations. The co-investigator will address differences in PPOS responses from patient vs student, without specifically revealing the personal answers of each, and allow for discussion of how scales can be aligned to better the patient-physician relationship. This discussion will be voice recorded for transcription and qualitative analysis by the investigators

Following the interview, the MHP students will transcribe the patient narrative. During the interview, the student and patient will agree on whether the narrative is written from the first or third person point of view.

The initial informed consent will have a specific series of check boxes to address whether the patient approves of dissemination of their story. This initial consent will specifically state that this narrative will not be published prior to their approval of the final product. The patient will also have the opportunity to declare which patient identifiers, if any, will be changed for the publication. The narrative will be presented to the patient, who will then have the opportunity to make changes and edits. If extensive edits are necessary, a subsequent narrative will be presented to the patient for final approval prior to publication. The investigators will make every effort to get the patient approval in person, however because of the possibility of the patient being discharged before the narrative has been composed, investigators will identify an acceptable method of communication with the patient outside of the hospital (email, phone call) for this purpose. In the case of the patient being discharged and needing to obtain approval, verbal approval over the phone will be obtained by a co-investigator and a witness, and will keep this documentation in a binder locked in the PI's office.

Following the completion of the interviews, the MHP students will meet for a focus group to discuss as a group their observations from their patient encounters. This focus group will be audio recorded and transcribed by the co-investigators for qualitative analysis

After all patient narratives have been completed, narratives may be published in an online or book format, following the consent that the patient provided.

Impact of Early Implementation of Narrative Medicine Techniques on Patient Centered Attitudes of Medical Students

Patients to People: Examining the Effects of Early Implementation of Narrative Medicine Techniques on Patient Centered Attitudes in Medical Students. A Qualitative Study

The PPOS is an 18 item questionnaire developed to evaluate patient centered care. The items are rated on a 6 point Likert-type scale. It has two separate parts, sharing and caring, that can be either summed or divided for scoring purposes. Higher scores indicate more patient centeredness.

Total from the questions related to "sharing" on the PPOS. The sharing portion relates to how open the provider is in sharing power in the patient-physician relationship, or in the case of the patient filling out the form, how much the patient wishes to share the power in the patient-physician relationship.

Total from the questions related to "caring" on the PPOS. The caring portion relates to how oriented the provider is in caring for the patient as a person and not just a disease.

qualitative measurement of topics and themes discussed in immediate post-interview discussion between the co-investigator, MHP student, and patient

qualitative measurement of topics and themes discussed in the focus group held following all MHP students completing their individual interviews

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Ovarian Tissue Freezing For Fertility Preservation In Women Facing A Fertility Threatening Medical Diagnosis/Treatment	NCT02678910	Cancer Hematologic Dis... Rheumatologic D... Infertility	Ovarian Cryopre...	12 Years - 41 Years	University of Kentucky
Impact of Early Implementation of Narrative Medicine Techniques on Patient Centered Attitudes of Medical Students	NCT03041571	Narrative Medic... Chronic Disease Terminal Illnes... Cancer Diabetes Mellit... Cystic Fibrosis Rheumatologic D... Oncologic Disor... Hematologic Dis...	Patient Provide... Interview perfo...	8 Years - 100 Years	University of Florida

Spots Global Cancer Trial Database for rheumatologic disorder