The effectiveness of ICSI versus conventional IVF in couples with non-male factor infertility: study protocol for a randomised controlled trial.

ABSTRACT

STUDY QUESTIONS Does ICSI result in a higher live birth rate as compared with conventional IVF in couples with non-male factor infertility? WHAT IS KNOWN ALREADY ICSI is primarily indicated for severe male factor infertility. While the use of ICSI for couples with non-male factor infertility has been increasing worldwide, this is not supported by data from randomised controlled trials. Evidence from non-randomised studies suggest no benefit from ICSI compared with conventional IVF in non-male factor infertility, if not a harm. STUDY DESIGN SIZE DURATION This randomised, open-label, multi-centre trial aims to compare the effectiveness of one ICSI cycle and one conventional IVF cycle in infertile couples with non-male factor infertility. A total of 1064 couples will be randomly allocated to an ICSI group and a conventional IVF group. The estimated duration of the study is 30 months. PARTICIPANTS/MATERIALS SETTING METHODS: Eligible couples are those whose husbands' total sperm count and motility are normal, have undergone ≤2 previous IVF/ICSI attempts, use antagonist protocol for ovarian stimulation, agree to have ≤2 embryos transferred and are not participating in another IVF study at the same time. Women undergoing IVM cycles, using frozen semen or having a poor fertilisation (≤25%) in previous cycle will not be eligible. Couples will be randomised to undergo ICSI or conventional IVF (11) with ongoing pregnancy resulting in live birth after the first embryo transfer of the started treatment cycle as the primary endpoint. All analyses will be conducted on an intention-to-treat basis. Effect sizes will be summarised as relative risk (RR), with precision evaluated by 95% CIs. STUDY FUNDING/COMPETING INTERESTS All authors declare having no conflict of interests with regards to this trial. This work was supported by a grant from MSD [MISP #57508]. TRIAL REGISTRATION NUMBER NCT03428919. TRIAL REGISTRATION DATE 8 February 2018. DATE OF FIRST PATIENT'S ENROLMENT 16 March 2018.