Infertility Clinical Trial
Official title:
A Comparison of Two Freezing Techniques
Verified date | October 2012 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this study is to determine the best way to freeze eggs in order to preserve the fertility potential of young women.
Status | Completed |
Enrollment | 18 |
Est. completion date | October 2012 |
Est. primary completion date | February 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 21 Years to 50 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | North Shore University Hospital | Manhasset | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health | EMD Serono |
United States,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Achievement of a pregnancy, as determined by a fetal heartbeat | 2 months | No | |
Secondary | Percentage of eggs that result in blastocyst formation | 1 week | No | |
Secondary | Oocyte survival (the percentage of eggs that survive the freeze-thaw procedure) | 2 days | No | |
Secondary | ICSI fertilization rate (percentage of eggs that fertilize) | 2 days | No | |
Secondary | Incidence rate of embryo formation (percentage of embryos formed/number of eggs fertilized) | 2 days | No |
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