Here is the design of a clinical trial:

Official Title: Randomized Control Study on the Impact of a Pozzi Tenaculum Forceps Use on the Success Rate of Intrauterine Insemination (IUI)

Included conditions:
- Infertility
- Insemination

Study Armgroups:
- {'label': 'Pozzi for intrauterine insemination', 'type': 'ACTIVE_COMPARATOR', 'description': 'Treatment done with a pozzi tenaculum forceps', 'interventionNames': ['Procedure: Intrauterine insemination']}
- {'label': 'No Pozzi for intrauterine insemination', 'type': 'ACTIVE_COMPARATOR', 'description': 'Treatment done without a tenaculum forceps', 'interventionNames': ['Procedure: Intrauterine insemination']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'Intrauterine insemination', 'description': 'Obligatory use of a Pozzi forceps tenaculum during intrauterine insemination', 'armGroupLabels': ['No Pozzi for intrauterine insemination', 'Pozzi for intrauterine insemination']}

Primary Outcomes:
- {'measure': 'Rate of live births', 'description': 'Live born delivery resulting from an intrauterine insemination cycle', 'timeFrame': '10 months after positive pregnancy test'}

Please estimate the sample size based on the assumption: 
Significance level of 0.05, power of 63% for 400 cases and 80% for 800 cases using Fisher's exact test; power of 43% for 400 cases and 80% for 800 cases using GEE logistic model; 1-3 cycles of inseminations; bootstrap resampling with 1000 samples; SAS V.9.4 used for estimation
Sample size
        The total sample of 400 cases at the time of the interim analysis provides 63% power of Fisherâs exact test to detect 17.7% of pregnancy following the use of Pozzi forceps compared with 10.7% of pregnancy without the use of forceps. The same estimation with 800 cases provides 80% of the power. All power was estimated using GPower V.3.1 with a significance level of 0.05.
        To estimate the power of a generalised estimating equation (GEE) logistic model that takes into account 1â3 cycles of inseminations, a sample of 400 simulated cases was created with a 17.7% pregnancy prevalence following the use of Pozzi forceps and 10.7% prevalence of pregnancy without the use of Pozzi forceps. A total of 1000 samples were resampled using bootstrap unrestricted random sampling from the simulated database. The power of the GEE logistics model was 43% for a total sample of 400 cases. The same procedure for a total sample of 800 cases provides 80% power for GEE logistic regression model. All estimation was done using SAS V.9.4.
        Finally, this sample size estimation (â¥180 cases by group) is in agreement with the recommendations of Rochon for GEE logistic regression with three repeated measurements (new).10