Ovarian Tissue Cryopreservation for Fertility Preservation

Ovarian Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens

The goal of this observational study is to learn about fertility preservation for pre-pubertal, peri-pubertal, and adult participants that are unable to pursue clinical standard of care fertility preservation such as egg (oocyte) and embryo cryopreservation.

In addition, this study will provide research tissue for the following Specific Aims:

1. To optimize techniques for cryopreservation of ovarian tissues from patients at significant risk for infertility.
2. To investigate factors affecting successful maturation ovarian tissue.

Participants will undergo a surgical procedure to remove an ovary (oophorectomy) to preserve their gonadal tissue for fertility preservation.

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Diseases; Cancer
• Intervention / Treatment: Diagnostic test: Infectious Disease Labwork; Diagnostic test: Fertility-Based Labwork

Detailed Description

The cure rate of cancer in children, adolescents and young adults continues to increase with advances in chemotherapy and/or radiation protocols. As more pediatric oncology patients become long-term survivors, the consequences of their treatment on their quality of life have become an important thrust of clinical oncology and basic science research. One of the most common and most devastating long-term sequelae following cancer treatment is infertility. Many chemotherapy and radiation-containing regimens for cancer therapy or prior to bone marrow transplantation can cause sterility in children and young adults. Fertility-preserving options are available for adult women (embryo freezing), but not all adult women are able to take advantage of this option since it requires fertilization. Some adult women are not able to cryopreserve embryos because they lack a partner or cannot delay treatment for the time required for ovarian stimulation. Currently, no fertility-preserving options are available for prepubescent girls who are not yet producing mature gametes and post-pubescent females whose follicular pool cannot be shielded from cancer therapy. However, experimental techniques are currently being developed to provide future alternatives for patients that preserve their ovarian tissue/cells prior to gonadotoxic treatment. In order to take advantage of these and future technologies, patients must harvest and preserve their ovarian tissue and/or oocytes (eggs) prior to the initiation of gonadotoxic therapy. This study will be available to girls and women from prepubertal years through 40 years of age who will undergo potentially sterilizing treatments. The primary objective of the proposed study is to develop techniques for long-term preservation of ovarian function through cryopreservation of ovarian tissue and/or cells prior to therapies that are likely to cause infertility (e.g., chemotherapy, radiation). This study will maintain cryopreserved ovarian tissue and/or cells for participating patients as a resource for future elective procedures to attempt fertility restoration. This study will also provide long-term follow-up on the fertility status of patients that will undergo a potentially sterilizing treatment for their primary disease or condition.

Fertility status has an important impact on the post-treatment quality of life for cancer survivors and other patients that receive gonadotoxic therapies (e.g., prior to bone marrow transplantation). Established fertility preserving therapies are available for adult women, but these therapies are not accessible or appropriate for all adult female patients. Currently there are no therapies to preserve the future fertility of preadolescent girls. However, new reproductive therapies are under development and may one day offer "fertile hope" to those survivors that do not currently have access to fertility preserving therapies. Clinical management of fertility-threatening diseases and treatments must have foresight of the gonadotoxic side effects and the potential for infertility. When no established fertility sparing options are available, it is reasonable to offer harvesting and cryopreservation of ovarian tissue as a possible means of fertility preservation. This study will provide a pool of research tissue that will be used to develop and test methods for manipulation and cryopreservation of ovarian tissue. Progress in these investigations may open up a range of new fertility preservation techniques to female patients that currently have no options. At the same time, a substantial portion of the patient's ovarian tissue will be cryopreserved and reserved for her own future use.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Rachel Neelley, BA; Phone Number: 1 4126417475; Email: fertilitypreservation@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Recruiting
      • Magee-Womens Hospital
      • Contact: Rachel Neelley, BA; Phone Number: 1 412-641-7475; Email: fertilitypreservation@upmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Eligible patients who will undergo an infertility-causing treatment and for whom standard of care fertility preservation procedures are not available will be identified by their physician.

Description

Inclusion Criteria:

• Be female age less than 40 years old.
• Unable or unwilling to make use of oocyte or embryo banking alone.
• Be scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy with risk of causing permanent and complete loss of subsequent ovarian function.
• Or, have a medical condition or malignancy that requires removal of all or part of one or both ovaries.
• Or, Have newly diagnosed or recurrent disease. Those who were not enrolled at the time of initial diagnosis (i.e., patients with recurrent disease) are eligible if they have not previously received therapy that is viewed as likely to result in complete and permanent loss of ovarian function.
• Have two ovaries if undergoing elective removal of an ovary for fertility preservation only.

Exclusion Criteria:

• Diagnosed with psychological, psychiatric, or other conditions which prevent giving fully informed consent.
• Diagnosed with an underlying medical condition that significantly increases their risk of complications from anesthesia and surgery.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cryopreservation; Participants will have autologous ovarian tissue cryopreserved for fertility preservation.	Diagnostic test: Infectious Disease Labwork; Infectious disease labs will be drawn and resulted.; Diagnostic test: Fertility-Based Labwork; Other labwork to understand fertility may be drawn.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Develop techniques for long-term preservation of female ovarian function through cryopreservation (freezing) of ovarian tissue and/or cells prior to therapies that are likely to cause infertility (e.g., chemotherapy, radiation).	Treatment with specific chemotherapeutic agents and regimens induces prolonged absence of menstrual cycle in women of reproductive age. Sterilizing agents are thought to act directly on the ovary and produce premature ovarian insufficiency. Techniques will be developed through utilizing scientifically proven standards for long-term preservation of ovarian tissue and/or cells prior to gonadotoxic treatment.	[10 years]
Maintain cryopreserved ovarian tissue and/or cells for participating patients as a resource for future elective procedures to attempt fertility restoration.	Ovarian tissue containing immature oocytes has been successfully cryopreserved in several animal models. When thawed, this tissue can be grafted into a host with resumption of both endocrine and reproductive function. Ovarian tissue cryopreservation has the important advantage of not requiring controlled ovarian hyperstimulation, thus, eliminating the delay in cancer therapy as well as elevated estradiol levels in patients with hormone sensitive cancers. After cancer therapy, participants can utilize their frozen ovarian tissue for transplantation or other applications, as eligible.	[10 years]

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: Kyle Orwig, PhD, University of Pittsburgh/ University of Pittsburgh Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2011
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Infertility; Ovary; Fertility; Ovarian; Fertility Preservation; Oncofertility
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: STUDY19080200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators will publish individual participant data. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.
• IPD Sharing Time Frame: We will only share IPD with the patient (and only the patient) within one year of enrollment. We share study protocol and ICF with collaborating sites annually.
• IPD Sharing Access Criteria: De-identified research data will be shared with collaborators via a-mail, and with the broader scientific community via publication and presentations at national/international meetings.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No