Here is the design of a clinical trial:

Official Title: In Vitro Fertilisation Versus Intracytoplasmic Sperm Injection in Patients Without Severe Male Factor Infertility (INVICSI): a Randomised, Controlled, Multicentre Trial

Included conditions:
- Infertility

Study Armgroups:
- {'label': 'Standard in vitro fertilisation (IVF)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Oocytes are fertilised with standard IVF. For details please see "Project Description".', 'interventionNames': ['Procedure: IVF']}
- {'label': 'Intracytoplasmic sperm injection (ICSI)', 'type': 'ACTIVE_COMPARATOR', 'description': 'Oocytes are fertilised with ICSI. For details please see "Project Description".', 'interventionNames': ['Procedure: ICSI']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'IVF', 'description': 'Fertilisation with standard in vitro fertilisation (IVF). For details please see "Project Description".', 'armGroupLabels': ['Standard in vitro fertilisation (IVF)']}
- {'type': 'PROCEDURE', 'name': 'ICSI', 'description': 'Fertilisation with intracytoplasmic sperm injection (ICSI). For details please see "Project Description".', 'armGroupLabels': ['Intracytoplasmic sperm injection (ICSI)']}

Primary Outcomes:
- {'measure': 'Cumulative live birth rate from first live birth episode of a study cycle', 'description': 'The cumulative first live birth from the oocyte collection. Includes transfer of fresh embryos and frozen-thawed embryos.', 'timeFrame': 'Minimum follow-up time is one year after inclusion'}

Please estimate the sample size based on the assumption: 
This is a superiority trial with a power of 80% and a two-sided p value of 5%. Postrandomisation exclusion is expected to be 5%.
Proposed sample size
          The rate of first live births after transfer of up to all of the transferable embryos from the first OPU is set to 45% in the conventional IVF group and 55% in the ICSI group. This is a superiority trial with a power of 80% and a two-sided p value of 5%. The sample size is estimated to be 392 patients in each group. Postrandomisation exclusion is expected to be 5%, resulting in a total of 824 patients.