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Vitrification of Oocytes From Female Cancer Patients to Preserve Their Fertility Potential


N/A
14 Years
42 Years
Not Enrolling
Female
Fertility

Thank you

Trial Information

Vitrification of Oocytes From Female Cancer Patients to Preserve Their Fertility Potential


Inclusion Criteria:



- Patients must be 14-42 year old females with a cancer diagnosis.

- Clearance letter from treating oncologist.

- Approval by program oncologist or her designee.

- Informed consent has to be signed after consultation with the program physician.
Minors require consent of a parent or a legal guardian and assent from the
participant.

- Life expectancy (predicted by their malignancy) of 5 or more years.

- Cancer diagnosis should have an expected cure rate of 50% or more, based upon
clinico-pathologic features.

Exclusion Criteria:

- Patients whose oncologist and the program oncologist concur that immediate oncologic
care should be rendered, not allowing sufficient time for a course of gonadotropin
therapy and egg retrieval.

- FSH level >20 MIU/ml, indicating abnormal ovarian function.

- Patients with stage IV cancers (*age appropriate women with stage IV advanced
Hodgkin's Lymphoma will be considered, as there is a significant long term survival
rate with this advanced disease).

- Patients with incurable cancer diagnoses.

- Patients who are unable or unwilling to sign the informed consent.

- Women cannot have an embryo transfer beyond age 50.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

successful pregnancy

Outcome Description:

the primary objective of this study is the establishment of a successful pregnancy, following a disease-free interval after treatment for her cancer; this interval will be patient-dependent and will undoubtedly vary between participants.

Outcome Time Frame:

nine months after transfer of embryo(s)

Safety Issue:

No

Principal Investigator

Avner Hershlag, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Center for Human Reproduction

Authority:

United States: Institutional Review Board

Study ID:

10-204A

NCT ID:

NCT01268592

Start Date:

October 2010

Completion Date:

March 2013

Related Keywords:

  • Fertility
  • fertility preservation
  • oocyte cryopreservation
  • vitrification
  • egg freezing
  • fertility preservation in female cancer patients

Name

Location

Center for Human ReproductionManhasset, New York  11030