Here is the design of a clinical trial:

Official Title: Improving Reproductive Function in Women With Polycystic Ovary Syndrome by High Intensity Interval Training: A Randomized Controlled Trial.

Included conditions:
- Polycystic Ovary Syndrome

Study Armgroups:
- {'label': '4x4 minutes interval training', 'type': 'EXPERIMENTAL', 'description': '4x4 minutes high intensity interval training with 4 minute intervals', 'interventionNames': ['Behavioral: 4x4 minutes high intensity interval training']}
- {'label': '10x1 minute interval training', 'type': 'EXPERIMENTAL', 'description': '10x1 minute high intensity interval training with 1 minute intervals', 'interventionNames': ['Behavioral: 10x1 minute high intensity interval training']}
- {'label': 'control', 'type': 'NO_INTERVENTION', 'description': 'Physical activity recommended'}

Interventions:
- {'type': 'BEHAVIORAL', 'name': '4x4 minutes high intensity interval training', 'description': 'Treadmill running/walking with 10 minutes varm-up at 60-70% of maximum heart rate, 4x4 minute intervals at 90-95% of maximum heart rate separated by 3-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.', 'armGroupLabels': ['4x4 minutes interval training'], 'otherNames': ['High-intensity exercise', 'Aerobic exercise']}
- {'type': 'BEHAVIORAL', 'name': '10x1 minute high intensity interval training', 'description': 'Treadmill running/walking with 10 minutes varm-up at 60-70% of maximum heart rate, ten 1-minute intervals at maximal intensity (that can be performed for one minute), separated by 1-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.', 'armGroupLabels': ['10x1 minute interval training'], 'otherNames': ['High-intensity exercise', 'Aerobic exercise']}

Primary Outcomes:
- {'measure': 'Menstrual frequency', 'description': 'Electronic menstrual diary', 'timeFrame': '1 year'}

Please estimate the sample size based on the assumption: 
Statistical power is set at 80%, significance level at 0.05, and standard deviation at 2 menstrual bleedings per year. A non-parametric test may be necessary due to non-normality, requiring a 15% increase in sample size. Additionally, a dropout rate of 10%-15% is expected.
Sample size and statistical analysis
        We computed the sample size for a one-way analysis of variance test with three groups. In women with PCOS, a menstrual frequency of on average 4.5 menstrual bleeding during 1âyear is expected.51 With a statistical power of 80%, a significance level of 0.05 and a SD of two menstrual bleeding during a 12-month period, we calculated that 48 women will be required to detect an increase in menstrual bleeding to 7.5 in the intervention groups.26 Because of the non-normality of menstrual frequency, it may be necessary to use a non-parametric test. Non-parametric tests require more participants and we, therefore, added 15% to the required sample size. Additionally, to allow for expected dropouts of 10%â15%, we aim to include 64 women in the study.
        We will perform all the statistical analyses blinded for group allocation. The primary analysis will be a comparison between groups for the number of menstrual bleeding during 12 months. We will adjust for the self-reported menstrual frequency at baseline. We will include all women who have reported menstrual frequency in the primary analysis, independent of adherence to the interventions, that is, intention-to-treat analysis. The number of pregnancies during the 16 weeks of intervention and during the 12-month follow-up will be compared between groups. Secondary outcome measures will be compared between groups after 16 weeks and after 12 months and adjusted for baseline values. We will do additional âper protocolâ analyses where we include women in the HIT groups that have completed >75% of the scheduled exercise sessions during the intervention period (for comparisons after 16 weeks) and a mean minimum of one HIT session/week during the 12-month follow-up (for comparisons at the end of follow-up).
        Results will be reported as means with 95% CIs and/or SD. We will report the effect of HIT as mean changes from baseline to 16 weeks of intervention and after 12 months of follow-up. We will use mixed models to test differences between groups. P values <0.05âwill be considered significant for both primary and secondary outcomes. We will also perform subgroup analyses to investigate differences between BMI categories and compare adherence rates and enjoyment of the two HIT protocols.