Inclusion criteria | Criterion for GDP? | Criterion for FB? |
---|---|---|
The man and woman (couple) are married. | Yes | Yes |
The couple combined must have at least one child (biological, adopted or stepchild). | No | Yes |
The couple desires the under-represented gender among all of their children (biological, adopted or stepchild). | No | Yes |
The couple wishes to minimize the risk of genetic disorders that are known or believed to be sex-linked or sex-limited. | Yes | No |
The husband and wife, and donor and/or surrogate mother (if applicable) have negative laboratory test results for HIV-1 antibody, Hepatitis B surface antigen, and Hepatitis C antibody. | Yes | Yes |
The wife or the donor of the eggs must be between the ages of 18–39 at the time of egg retrieval or insemination. | No | Yes |
Both husband and wife agree to participate in the ongoing follow-up, as evidenced by providing signed medical release forms to obtain newborn and pediatric records for any children conceived during the clinical study. | Yes | Yes |
Both husband and wife have signed an informed consent. | Yes | Yes |
Exclusion criteria | ||
A history of a major congenital malformations or known chromosomal abnormality in the husband, wife or donor (egg or sperm) or in their prior children. | No | Yes |
A clinically significant disease in the woman who will be carrying the pregnancy. | Yes | Yes |
Abnormal, undiagnosed, gynecological bleeding in the woman who will be carrying the pregnancy. | Yes | Yes |
Known allergy or hypersensitivity to the dye used for DNA staining in the woman who will be carrying the pregnancy. | Yes | Yes |
Known current substance abuse in couple (husband and wife) that is the intended parents, or in the woman who will be carrying the pregnancy. | Yes | Yes |