• V Q Dang, L N Vuong, T M Ho, A N Ha, Q N Nguyen, B T Truong, Q T Pham, R Wang, R J Norman, and B W Mol.
• IVFMD, My Duc Hospital, 4 Nui Thanh, Tan Binh District, Ho Chi Minh City, Vietnam.
• Hum Reprod Open. 2019 Jan 1; 2019 (2): hoz006.

Study QuestionsDoes ICSI result in a higher live birth rate as compared with conventional IVF in couples with non-male factor infertility?What Is Known AlreadyICSI 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 DurationThis 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 MethodsEligible 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 (1:1) 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 InterestsAll 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 NumberNCT03428919.Trial Registration Date8 February 2018.Date Of First Patient’s Enrolment16 March 2018.

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