Comparing Microfluidic Chip and Density Gradient Centrifugation for Sperm Preparation in IVF with Preimplantation Genetic Testing

What this Trial Is About

This research investigates two sperm preparation methods used during in vitro fertilization IVF for infertile women undergoing preimplantation genetic testing PGT. The study aims to compare the microfluidic chip method and density gradient centrifugation to evaluate their effects on the euploidy rate of embryos and other IVF outcomes such as pregnancy rates and obstetric complications. Eligible couples will be recruited during ovarian stimulation for IVF, and randomization will take place on the day of oocyte retrieval in a double-blind manner. Participants will be assigned to either the microfluidic chip group, where sperm will be prepared using a specialized device following the manufacturers instructions, or the density gradient centrifugation group, where sperm will be separated using a gradient centrifugation method and washed before fertilization. Women will undergo ovarian stimulation using injections and monitoring, followed by oocyte retrieval. Fertilization is performed via intracytoplasmic sperm injection using the prepared sperm samples. Embryos will be tested genetically, and only chromosomally normal blastocysts will be used for frozen embryo transfer in subsequent cycles. During the study, semen samples will be collected and evaluated for quality and DNA damage. Pregnancy outcomes will be tracked through urine tests and ultrasounds, with detailed data collected on pregnancy progress, delivery, birth weights, and any complications. The primary outcome measured is the euploid rate of blastocysts within three months, and secondary outcomes include live birth rates and pregnancy outcomes over three years. Participants will be closely monitored throughout the IVF process and follow-up periods.

Microfluidic Chip vs Density Gradient Centrifugation on the Euploidy Rate of Pre-implantation Genetic Testing