MicroSort^® Family Balancing Policy

Family balancing is the process of bringing the number of children of each gender in a family closer to equal. This term cannot apply to a first child, nor can it apply to a family, in which there are already an equal number of boys and girls. MicroSort® is a procedure that is currently in an FDA clinical trial. The only couples who are eligible for the MicroSort® clinical trial are couples who want to be able to choose the gender of the child either for family balancing or for genetic disease prevention. In order to help assure that couples seeking to use MicroSort® for family balancing have an unequal number of children and are not seeking to influence the gender of a first child or increase an imbalance, GIVF is requiring couples to provide copies of birth certificates for all of their children.

For those couples whose pregnancy will involve a gestational carrier, another requirement of the clinical trial is that a couple may employ MicroSort® for only one pregnancy attempt at a time. This relates to a requirement that couples avoid situations where family imbalance is likely to result from multiple simultaneous pregnancies, and it likewise relates to a requirement to provide MicroSort® with the outcome of all ongoing pregnancies. In many case, two simultaneous pregnancies could create a reasonable chance that two (or more) children will produce another family imbalance (in the opposite direction). For initial and continued enrollment, the MicroSort® clinical trial also requires that all children be reported, including any ongoing pregnancy.

Consistent with this policy, additional vials of sorted semen may be released only if its intended use is consistent with this definition of family balancing (or genetic disease prevention), and if it is consistent with knowing the outcome of all prior pregnancies, including ongoing pregnancies. Any circumstances that may be inconsistent with family balancing or that avoids full reporting of all pregnancies may result in exclusion from entry to the clinical trial or exclusion from further participation in the clinical trial.