This revision supplement to our grant, Subfertility and Assisted Conception Study of Parent and Child Health Outcomes, adds laboratory data to an existing database to enable the study of the effect of laboratory manipulations on the health of infants and children born of assisted reproductive technology (ART) treatment. The parent grant links data from the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS) database to birth certificates, hospital discharges and other vital records in Massachusetts. One goal of that grant is to evaluate the long term health of ART treatment and underlying subfertiltiy on the health of infants and long term health of children. The hypothesis for this revision is that variations in ART culture conditions and freeze protocols have direct effects on both the success rates of treatment and the health of offspring deriving from that treatment.
The aims of this study are as follows:
Aim 1 : To investigate the association between culture media type and cycle outcomes, obstetric outcomes, perinatal outcomes (perinatal mortality, preterm, very preterm birth, birthweight, and SGA or LGA), and subsequent health of offspring. Hypothesis: Birth rates and perinatal outcomes are improved by use of culture media containing 19-22 as compared with 8-11 amino acids. We will compare outcomes according to a major differentiating factor in commercial media, the amino acid content (19-20 amino acids vs. 8-11 amino acids.). We will control for the day of embryo transfer and other culture conditions including protein supplementation (Synthetic Serum Supplement vs. Human Serum Albumen), oxygen tension, use of oil overlay in embryo culture dishes, embryo density (one or more embryos per dish), and other potential confounders such as maternal characteristics (age, race subfertility, chronic disease), and ART treatment parameters (intracytoplasmic sperm injection, assisted hatching, preimplantation genetic diagnosis/screening, cleavage vs. blastocyst transfer, number of embryos transferred).
Aim 2 : To determine whether freeze methodology (slow freezing vs. vitrification) is associated with cycle outcomes (implantation, pregnancy, miscarriage and live birth rate), obstetric outcomes, perinatal outcomes (preterm, very preterm, birthweight, and small and large for gestational age birthweight), and subsequent health of offspring. Hypothesis: Use of vitrification results in improved live birth rates, perintatal outcomes and subsequent child health, compared with use of slow freeze methodology. Outcomes will be adjusted for culture conditions, as well as for other ART parameters such as day of transfer, use of assisted hatching and preimplantation genetic diagnosis/screening, and underlying parental subfertility and medical conditions of the mother.
This project revision supplement will add laboratory data to our existing Massachusetts Outcome Study of Assisted Reproductive Technology database to study the effect of laboratory culture media and embryo freeze protocols on the health of resulting infants and children. The parent grant links data from a national Assisted Reproductive Technology(ART) database with vital records data in Massachusetts to enable the study of the health of infants and health of children to age four born to fertile mothers, subfertile mothers and mothers treated with ART. The addition of laboratory data from two large clinics provides an excellent opportunity to directly study the effect of the laboratory conditions on the health of these children.
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