Ovarian Tissue Cryopreservation for Fertility Preservation

NCT05875155 | Recruiting

• 1 other identifier: STUDY19080200
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer; Autoimmune Diseases

Keywords

Fertility; Fertility Preservation; Infertility; Ovary; Ovarian; Oncofertility

Outcome Measures

Primary Outcomes (2)

• 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]

Study Arms (1)

Cryopreservation

Participants will have autologous ovarian tissue cryopreserved for fertility preservation.

Diagnostic Test: Infectious Disease Labwork; Diagnostic Test: Fertility-Based Labwork

Interventions

Fertility-Based Labwork DIAGNOSTIC_TEST

Other labwork to understand fertility may be drawn.

Cryopreservation

Infectious Disease Labwork DIAGNOSTIC_TEST

Infectious disease labs will be drawn and resulted.

Cryopreservation

Eligibility Criteria

• Age: Up to 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Ovarian Tissue

MeSH Terms

Conditions

Neoplasms; Autoimmune Diseases; Infertility

Condition Hierarchy (Ancestors)

Immune System Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Kyle Orwig, PhD

  University of Pittsburgh/ University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Neelley, BA

CONTACT

4126417475; fertilitypreservation@upmc.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 13, 2023
• First Posted: May 25, 2023
• Study Start: January 13, 2011
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• 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.
• 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.

Locations

US (1)