Study period | ||||||||
Enrolment | Pre-allocation | Allocation | Post-allocation | Close-out | ||||
Content | Screening and baseline assessment | Controlled ovarian hyperstimulation | Oocyte retrieval and randomisation | Assessment of embryo | Embryo transfer | Evaluation of pregnancy | Follow-up of pregnancy | |
Time point | T0 −3 month | T1 −1 month | T2 0 month | T3 1–3 days | T4 3 days | T5 1 month | T6 3–10 months | T7 12 months |
Enrolment | ||||||||
Eligibility screen | × | × | × | |||||
Informed consent | × | |||||||
Allocation | × | |||||||
Interventions | ||||||||
ICSI | × | |||||||
Conventional IVF | × | |||||||
Assessments | ||||||||
Baseline data | × | |||||||
Laboratory tests | × | × | × | × | × | × | × | |
Fertilisation | × | |||||||
Embryo quality | × | |||||||
Pregnancy tests | × | |||||||
Pregnancy outcomes | × | × | ||||||
Fetus information | × | × | ||||||
Neonate information | × | × | ||||||
Safety assessment | × | × | × | × | × | × |
ICSI, intracytoplasmic sperm injection; IVF, in vitro fertilisation.