Recruiting

Ovarian Tissue Cryopreservation

Sponsor:

University of Pittsburgh

Code:

NCT05875155

Conditions

Cancer

Autoimmune Diseases

Eligibility Criteria

Sex: Female

Age: 0 - 39

Healthy Volunteers: Not accepted

Interventions

Infectious Disease Labwork

Fertility-Based Labwork

Study Details

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. 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.

Conditions

Cancer

Autoimmune Diseases

Study ID

NCT05875155

Start date

Jan 13, 2011

Status verified date

Mar, 2026

Completion date

Jan, 2031

Anticipated

Primary completion date

Jan, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0 - 39

Healthy Volunteers: Not accepted

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 Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Cryopreservation

Participants will have autologous ovarian tissue cryopreserved for fertility preservation.

Interventions

Infectious Disease Labwork

Infectious disease labs will be drawn and resulted.

Fertility-Based Labwork

Other labwork to understand fertility may be drawn.

Primary outcome measure

  • 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). [ Time Frame: [10 years] ]
  • Maintain cryopreserved ovarian tissue and/or cells for participating patients as a resource for future elective procedures to attempt fertility restoration. [ Time Frame: [10 years] ]

Central Contacts and Locations

Central contacts

Rachel Neelley, BA

4126417475fertilitypreservation@upmc.edu

Locations

Magee-Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Rachel Neelley, BA

4126417475fertilitypreservation@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Keywords

  • Fertility
  • Fertility Preservation
  • Infertility
  • Ovary
  • Ovarian
  • Oncofertility

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-03-04.