Intrauterine insemination is a commonly used method for Medically Assisted Reproduction for
patients with mild male factor infertility, anovulation, endometriosis, and unexplained
infertility. It is also the procedure of choice in cases of lesbian couples or single women,
using donor sperm.
During the IUI procedure, the sperm suspension is introduced into the uterus through the
cervix canal using an insemination catheter containing 0.4 ml sperm. Before sperm can be used
in IUI, it must first be processed. The aim of semen preparation is to select the best sperm
cell population (highly motile, morphologically normal spermatozoa with minimal DNA damage)
with the highest fertilization potential.
One of the most used sperm preparation technique is DGC. This technique allows the separation
of sperm cells based on their density. Morphologically normal and abnormal spermatozoa have
different densities. A mature morphologically normal spermatozoon has a slightly higher
density, whereas an immature and morphologically abnormal spermatozoon has a lower density.
During this procedure, raw semen sample is placed on 2 gradients: a lower phase (80%) and an
upper phase (40%) followed by centrifugation. The composition of the gradients include a
colloidal suspension of silica particles. At the end of centrifugation, each spermatozoa is
situated at the gradient level that matches its density. The highly motile, morphologically
normal, viable spermatozoa form a pellet at the bottom of the tube. This procedure is
relatively easy to perform but both the centrifugation steps and the silica particle are
considered to have a negative impact on DNA integrity.
Recently, microfluidic technology was introduced as an alternative to the conventional sperm
sorting techniques. As this procedure does not require semen processing, it reduces the sperm
preparation time and eliminates sperm DNA damaging procedures (e.g. by centrifugation). This
technology is a chemical-free method of sorting healthy normal sperm using a sterile
disposable ZyMōt Multi (850µL) sperm separation device. Sperm selected by this device proved
to have better motility and less DNA damage compared to DGC procedure. More recently, the
efficacy of this device has been reported to significantly increase ongoing pregnancy rate
when compared with DGC in IUI cycles. However, large, correct studies that investigate live
birth rate are missing.
The present study aims to determine whether the use of ZyMōt Multi (850µL) device for sperm
selection improves the live birth rate in IUI patients as compared to the standard DGC
procedure. Couples undergoing IUI procedure will be included in the study if they are planned
for IUI with fresh autologous ejaculate.
Patients that fulfill the inclusion criteria will be randomly allocated to one of the two
sperm selection methods: DGC (standard) or ZyMōt Multi (850µL) device (treatment) groups. The
randomization will be performed based on an electronically generated list. A patient
participation to the study will be limited to 3 consecutive IUI attempts (within a period of
6 months). Same semen preparation protocol used in the 1st IUI attempt [ZyMōt Multi (850µL)
or DGC] will be used in the next 2 consecutive IUIs. Following the IUI procedure (with sperm
selected with either one of the two methods), the patients will be monitored for pregnancy,
clinical pregnancy and neonatal outcome.