Table 1.
Schedule of enrollment, interventions and assessments
| Enrollment | Pre allocation | Allocation | Post allocation | Close-out | ||||||
| Content | Screening and baseline assessment | Controlled ovarian hyperstimulation | Oocyte retrieval and semen preparation | ICSI and Assessment of embryo | Blastocyst culture and randomization | PGT-A and/or Embryo frozen | Embryo transfer | Evaluation of pregnancy | Follow-up of pregnancy | |
| Time point | T0 3 months | T1 1 month | T2 0 months | T3 1–2 days | T4 5–6 days | T5 1–2 months | T6 4–5 days | T7 1 month | T8 3–10 months | T9 3 months |
| Enrollment | ||||||||||
| Eligibility screen | √ | √ | √ | √ | √ | |||||
| Informed consent | √ | |||||||||
| Allocation | √ | |||||||||
| Interventions | ||||||||||
| Conventional ICSI | √ | |||||||||
| ICSI+PGT-A | √ | |||||||||
| Assessment | ||||||||||
| Baseline data | √ | |||||||||
| Laboratory tests | √ | √ | √ | √ | √ | √ | √ | |||
| Fertilisation | √ | |||||||||
| Embryo quality | √ | √ | ||||||||
| Pregnancy tests | √ | |||||||||
| Pregnancy outcomes | √ | √ | ||||||||
| Fetus information | √ | √ | ||||||||
| Safety assessment | √ | √ | √ | √ | √ | √ |
ICSI, intracytoplasmic sperm injection; PGT-A, preimplantation genetic testing for aneuploidies.