Status:
COMPLETED
A Comparison of Two Freezing Techniques
Lead Sponsor:
Northwell Health
Collaborating Sponsors:
EMD Serono
Conditions:
Infertility
Eligibility:
FEMALE
21-50 years
Phase:
NA
Brief Summary
The purpose of this study is to determine the best way to freeze eggs in order to preserve the fertility potential of young women.
Detailed Description
Human egg freezing is rapidly becoming a vital tool in Assisted Reproductive Technology. Candidates for egg freezing include women without partners who wish to preserve their fertility; cancer patient...
Eligibility Criteria
Inclusion
- donors: women ages 21-32 who wish to donate their eggs; must pass medical, physical and psychological screening.
- recipients: women under the age of 50 who wish to have eggs donated to them through the Donor Egg Program and who aslo pass the medical, physical and psychological screening.
Exclusion
- donors: those who do not pass the genetic screening or psychological testing, as described below
- recipients: those who do not pass the screening.
- The genetic screening of donors will involve the following:
- All donors will be screened for Cystic Fibrosis, Fragile X and Spinomuscular Atrophy (SMA).
- In addition, donors of Ashkenazi Jewish origin will be screened for Gaucher's disease, Canavan,Tay -Sachs, Familial Dysautonomia, Niemann Pick, Fanconi's Anemia, Bloom and Mucolipidosis Type IV.
- Donors of African-American origin will be screened for Sickle-Cell disease.
- Donors of Asian, Mediterranean, Latino or Hispanic origins will be screened for Thalassemia.
- Recipient Screening: A Reproductive Endocrinologist (RE) at the Center will take a detailed history and perform a physical examination on all potential recipients. The RE will assess the health of the potential recipient in order to assess her capacity to carry a pregnancy. Previous IVF cycles, successful or unsuccessful, will have no implication on recipient selection.
- The recipient and her partner (if applicable) will meet with the program psychologist. The psychological evaluation is detailed below.
- Psychological evaluation: A psychological evaluation will be conducted of the Recipient, her partner (if applicable) and the Donor. The purpose of these evaluations is to determine the suitability of the parties to participate in the Donor Egg Program. Psychological tests will be administered by the Center as part of the evaluation process.
- These evaluations may result in a recommendation that one and/or all of the parties not participate in the Donor Egg Program. The psychologist will not be providing any advice or treatment to the Donor or Recipient(s). Nor will the Donor or Recipient(s) be entitled to the results of the Psychologist's evaluation. The Psychologist will provide the results of his/her evaluations to the Center for Human Reproduction.
- As with our standard Donor Egg Program practices, there will be an upper age limit of 50 years for all recipients participating in the study.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00852306
Start Date
February 1 2009
End Date
October 1 2012
Last Update
October 10 2012
Active Locations (1)
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1
North Shore University Hospital
Manhasset, New York, United States, 11030