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Table 1 Inclusion and exclusion criteria for participation in the MicroSort a clinical study: Genetic Disease Prevention (GDP) and Family Balancing (FB) indications b

From: The effectiveness of flow cytometric sorting of human sperm (MicroSort®) for influencing a child’s sex

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
  1. aMicroSort is a process of flow cytometric sorting human sperm to increase the proportion of X- or Y-chromosome-bearing cells in the sorted specimen. The differential fluorescence emitted by stained X- vs. Y-chromosome-bearing sperm enables the identification and selection of X- or Y-bearing cells such that the sorted specimen is enriched in the targeted sperm. Sorted sperm may be used to attempt to establish pregnancy so as to influence the likelihood that the baby will be of a particular sex.
  2. bIndications = GDP, FB: Participation in the MicroSort clinical study to reduce the risk of sex-linked/ sex-limited genetic disease in future children (GDP) or to balance the sex ratio among current children (FB).