Here is the design of a clinical trial:

Official Title: Preimplantation Genetic Screening in Patients With Male Factor Infertility

Included conditions:
- Infertility, Male
- Diagnosis, Preimplantation

Study Armgroups:
- {'label': 'ICSI without PGS', 'type': 'EXPERIMENTAL', 'description': 'Selection of embryos are based on blastocyst morphology criteria on day 5. A maximum of 2 embryos will be transferred for each treatment cycle.', 'interventionNames': ['Procedure: ICSI without PGS']}
- {'label': 'ICSI with PGS', 'type': 'EXPERIMENTAL', 'description': 'PGS will be applied to select embryos on day 5, only euploid embryos will be transferred.\n\nA maximum of 2 embryos will be transferred for each treatment cycle.', 'interventionNames': ['Procedure: ICSI with PGS']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'ICSI without PGS', 'description': 'Selection of embryos are based on morphology criteria on the 5th day of ICSI.', 'armGroupLabels': ['ICSI without PGS']}
- {'type': 'PROCEDURE', 'name': 'ICSI with PGS', 'description': 'PGS will be applied to selected embryos on the 5th day of ICSI.', 'armGroupLabels': ['ICSI with PGS']}

Primary Outcomes:
- {'measure': 'live birth rate', 'description': 'This will be based on the outcome of either the PGS+ICSI or the outcome of the ICSI after first embryo transfer cycle.', 'timeFrame': '42 weeks'}

Please estimate the sample size based on the assumption: 
Significance level (α) is set at 0.05, power (β) is set at 0.20, and a dropout rate of 20% is considered. The significance level for interim analysis is 0.001 and 0.05 for the final analysis.
Sample size
        According to our previous research and the average live birth rate calculated over all study sites, the live birth rate of conventional IVF with non-male factor infertility is about 35% per cycle. And the live birth rate of ICSI with male factor infertility is about 25% per cycle. If we estimated the live birth rate of our control group (conventional ICSI group) is 25%, and ICSI+PGT-A can improve the live birth rate of severe male factor infertility to about 35%. Set Î±=0.05 and Î²=0.20, according to the sample size calculation formula, we need 188 participants in each group. Plus taking consideration a dropout of 20%, the total participant recruitment number is 450 (the ratio between groups will be 1:1). For the interim analysis, we will use the Haybittle-Peto boundary. The significance level for the interim analysis will be 0.001 and 0.05 for the final analysis.16