Randomised double-blind controlled study protocol of the cumulative live birth rate of in vitro fertilisation...

Semen samples are commonly processed by a density gradient centrifugation method to isolate the most motile spermatozoa for fertilisation during in vitro fertilisation (IVF). Centrifugation can cause considerable damage to spermatozoa by the reactive oxygen species produced during the process, which has a negative effect on the IVF success. A microfluidic chip is an alternative sperm preparation technique using a miniaturised device containing channels and chambers in the microscale range for nanoparticle preparation. This technology enables the selection of mobile spermatozoa from semen samples without the need of centrifugation, leading to reduced DNA fragmentation. This study aims to compare the cumulative live birth rate of IVF following sperm preparation by a microfluidic chip method versus a density gradient centrifugation method.

This is a randomised double-blind study. Infertile patients attending the Centre of Assisted Reproduction and Embryology, Queen Mary Hospital and Kwong Wah Hospital for IVF will be recruited. With an anticipated 10% increase in live birth rate following the use of a microfluidic chip method, the calculated sample size is 516 women in each group to give a power of 0.8 and type 1 error of 0.05. Assuming a 10% drop-out rate, the total sample size is set to be 1136 or 568 women in each group. They will be randomly assigned on the day of oocyte retrieval by a laboratory staff into one of the following two groups: (1) the microfluidic chip group and (2) the density gradient group for sperm preparation and subsequent use in fertilisation. Other IVF procedures will be the same as our standard practice. Both patients and clinicians were blinded from the group allocation. The primary outcome is the cumulative live birth rate defined as the number of pregnancies leading to live birth within 6 months of randomisation. The cumulative live birth rates between the two groups will be analysed by χ² test.

Ethical approval was granted from the Institutional Review Board of The University of Hong Kong/Hospital Authority Hong Kong West Cluster (Approval Number: UW 23-293) and the Institutional Review Board of Kwong Wah Hospital (Approval Number: KC/KE-23-0108/FR-4). A written informed consent will be obtained from each woman before any study procedure according to good clinical practice. The results of this randomised trial will be disseminated in a peer-reviewed journal.

NCT06005311.