Comparing Live Birth Rates Using ZyMt Multi Device Versus Density Gradient Centrifugation for Intrauterine Insemination in Infertility Treatment

What this Trial Is About

This research aims to compare two sperm preparation methods for couples undergoing Intra Uterine Insemination IUI as a treatment for infertility, including mild male factor infertility, anovulation, endometriosis, unexplained infertility, lesbian couples, or single women using donor sperm. The study evaluates whether using the ZyMt Multi 850L sperm separation device improves live birth rates compared to the standard Density Gradient Centrifugation DGC method. This pilot randomized controlled trial is conducted at a single center and plans to enroll couples referred for IUI with fresh autologous semen. Participants will be randomly assigned to either the standard DGC sperm preparation or the ZyMt Multi device group. The DGC method separates sperm based on density using centrifugation steps with silica particle gradients, while the ZyMt Multi device uses a chemical-free, microfluidic sorting process without centrifugation to select motile, morphologically normal sperm. The selected sperm are then used in up to three consecutive IUI attempts within six months, maintaining the assigned sperm preparation method throughout. During the study, couples will undergo IUI procedures using the sperm selected by their assigned method, followed by monitoring for pregnancy, clinical pregnancy, and neonatal outcomes. The primary outcome measured is the cumulative live birth rate after three IUIs within nine months. Secondary outcomes include pregnancy and miscarriage rates within specified timeframes. The study includes detailed semen processing, ultrasound monitoring of follicles and tubes, and follow-up on pregnancy outcomes.

Live Birth Rate After Sperm Selection Using ZyMōt Multi (850µL) Device for Intra Uterine Insemination