Recruiting

Ovarian Tissue

Sponsor:

Weill Medical College of Cornell University

Code:

NCT01558544

Conditions

Cancer

Risk of Premature Ovarian Failure

Fertility Preservation

Eligibility Criteria

Sex: Female

Age: 0 - 45

Healthy Volunteers: Not accepted

Interventions

surgery to remove ovaries or high dose chemotherapy

Study Details

Brief summary:

The study hopes to contribute to the development of technologies of ovarian tissue freezing-thawing and in vitro maturation of immature eggs such that a person at risk for premature ovarian failure might be able to conceive a genetically related child.

Conditions

Cancer

Risk of Premature Ovarian Failure

Fertility Preservation

Study ID

NCT01558544

Start date

Apr, 1997

Status verified date

Oct, 2025

Completion date

Oct 31, 2029

Anticipated

Primary completion date

Oct 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Females 0-45 years of age who are premenopausal
  • Treatment plan that will likely result in premature menopause or premature ovarian failure
  • This includes patients receiving:
  • Cancer treatment with abdominal pelvic irradiation and/or high dose chemotherapy
  • Surgery that requires removal of ovaries for medical condition or disease, e.g. Prophylactic oophorectomy in BRCA patients
  • Patient is unable or unwilling to pursue fertility preservation by freezing oocytes or embryos.
  • Previous treatment for cancer is acceptable if patient still has ovarian function
  • Patient is medically stable enough to undergo surgery (cleared for anesthesia)

Exclusion Criteria:

  • Patients not meeting the above criteria
  • Patients who have not received medical clearance from their physicians to undergo surgery
  • Patients already experiencing menopause.

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Use of high dose chemotherapy

Use of chemotherapy without removal of the disease ovary.

Interventions

surgery to remove ovaries or high dose chemotherapy

oophorectomy to remove a disease ovary.

Primary outcome measure

  • CRYOPRESERVATION OF OVARIAN TISSUE FOR POTENTIAL IN VITRO MATURATION OR AUTOLOGOUS TRANSPLANTATION [ Time Frame: 6 months to a year post surgery, hormone testing will be performed to test ovarian function. ]

Central Contacts and Locations

Central contacts

Rodriq E. Stubbs, NP

646-962-3276res2011@med.cornell.edu

Locations

Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Rodriq Stubbs, NP

646-962-3276res2011@med.cornell.edu

Mitasha C. Joseph, RN, MPA

646-962-3382mij2008@med.cornell.edu

Principal Investigator:

Glenn Schattman, MD

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Dec 10, 2025

Last verified

Oct, 2025

Keywords

  • Ovarian tissue cryopreservation
  • Ovarian tissue transplantation
  • Fertility preservation
  • Risk of premature ovarian failure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2025-12-10.