NCT01558544

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable cancer

Timeline
43mo left

Started Apr 1997

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Apr 1997Oct 2029

Study Start

First participant enrolled

April 1, 1997

Completed
14.9 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 20, 2012

Completed
17.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2029

Last Updated

December 10, 2025

Status Verified

October 1, 2025

Enrollment Period

32.6 years

First QC Date

February 16, 2012

Last Update Submit

December 9, 2025

Conditions

CancerRisk of Premature Ovarian FailureFertility Preservation

Keywords

Ovarian tissue cryopreservationOvarian tissue transplantationFertility preservationRisk of premature ovarian failure

Outcome Measures

Primary Outcomes (1)

  • CRYOPRESERVATION OF OVARIAN TISSUE FOR POTENTIAL IN VITRO MATURATION OR AUTOLOGOUS TRANSPLANTATION

    Ovarian tissue cryopreservation Survival of tissue undergoing cryopreservation, thawing and maturation of immature eggs.

    6 months to a year post surgery, hormone testing will be performed to test ovarian function.

Study Arms (1)

Use of high dose chemotherapy

OTHER

Use of chemotherapy without removal of the disease ovary.

Procedure: surgery to remove ovaries or high dose chemotherapy

Interventions

surgery to remove ovaries or high dose chemotherapyPROCEDURE

oophorectomy to remove a disease ovary.

Also known as: Use of high dose chemotherapy without removal of disease ovary.
Use of high dose chemotherapy

Eligibility Criteria

AgeUp to 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Glenn Schattman, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodriq E. Stubbs, NP

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

March 20, 2012

Study Start

April 1, 1997

Primary Completion (Estimated)

October 31, 2029

Study Completion (Estimated)

October 31, 2029

Last Updated

December 10, 2025

Record last verified: 2025-10

Locations

US(1)