Here is the design of a clinical trial:

Official Title: Graceful Lifestyle Changes Intervention Study for Women With PCOS and Infertility

Included conditions:
- Polycystic Ovary Syndrome
- Infertility

Study Armgroups:
- {'label': 'Graceful Lifestyle Changes & MYO', 'type': 'EXPERIMENTAL', 'description': 'The 12-week lifestyle intervention will incorporate three lifestyle changes: a low-glycemic diet, increased exercise, and stress reduction through meditation and mindfulness.\n\nIn addition, this group will take myo-inositol (6 grams in juice or water every morning).', 'interventionNames': ['Behavioral: Graceful Lifestyle Changes', 'Dietary Supplement: Myo-inositol']}
- {'label': 'Graceful Lifestyle Changes', 'type': 'EXPERIMENTAL', 'description': 'The 12-week lifestyle intervention will incorporate three lifestyle changes: a low-glycemic diet, increased exercise, and stress reduction through meditation and mindfulness.\n\nIn addition, this group will take a white powder placebo (6 grams in juice or water every morning).', 'interventionNames': ['Behavioral: Graceful Lifestyle Changes']}
- {'label': 'Letrozole & MYO', 'type': 'PLACEBO_COMPARATOR', 'description': 'The women assigned to the fertility medication group will be prescribed letrozole. The initial dose will be 5 mg daily for five days and the dose can be increased by 2.5 mg to a total daily dose of 7.5 mg if necessary depending on ovulatory response, as in clinical practice. This treatment regimen will continue for three cycles (approximately the same period of time as the treatment group) or until pregnancy is achieved.\n\nIn addition, this group will take myo-inositol (6 grams in juice or water every morning).', 'interventionNames': ['Dietary Supplement: Myo-inositol', 'Drug: Letrozole']}
- {'label': 'Letrozole', 'type': 'PLACEBO_COMPARATOR', 'description': 'The women assigned to the fertility medication group will be prescribed letrozole. The initial dose will be 5 mg daily for five days and the dose can be increased by 2.5 mg to a total daily dose of 7.5 mg if necessary depending on ovulatory response, as in clinical practice. This treatment regimen will continue for three cycles (approximately the same period of time as the treatment group) or until pregnancy is achieved.\n\nIn addition, this group will take a white powder placebo (6 grams in juice or water every morning).', 'interventionNames': ['Drug: Letrozole']}

Interventions:
- {'type': 'BEHAVIORAL', 'name': 'Graceful Lifestyle Changes', 'description': 'Participants will be educated in small groups of 8-10. A wellness booklet designed by physicians and researchers at Grace Fertility Centre will be provided.The target diet for our study is 45% carbohydrates and 55 grams of glycemic load. Participants will keep a 3-day food diary at baseline, 4, 8 and 12 weeks. Secondly, participants will be provided a pedometer and a goal to reach 10,000 steps a day. The third aspect of the program will be to decrease overall stress through mindfulness. Educational sessions will be held to teach the relaxation response and meditation techniques such as breathing and grounding exercises. Participants will be required to meditate for at least 20 minutes each day and record this.', 'armGroupLabels': ['Graceful Lifestyle Changes', 'Graceful Lifestyle Changes & MYO'], 'otherNames': ['GLC']}
- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Myo-inositol', 'description': 'Myo-inositol will be consumed in juice or water every morning (6 grams) for 12 weeks.', 'armGroupLabels': ['Graceful Lifestyle Changes & MYO', 'Letrozole & MYO'], 'otherNames': ['Inositol', 'MYO']}
- {'type': 'DRUG', 'name': 'Letrozole', 'description': 'Letrozole will be administered to patients. The initial dose will be 5 mg daily for five days and the dose can be increased by 2.5 mg to a total daily dose of 7.5 mg if necessary depending on ovulatory response, as in clinical practice. This treatment regimen will continue for three cycles (approximately the same period of time as the treatment group) or until pregnancy is achieved.', 'armGroupLabels': ['Letrozole', 'Letrozole & MYO']}

Primary Outcomes:
- {'measure': 'Ovulation Occurence', 'description': 'Ovulation is the primary outcome and expressed as any ovulation (categorical "yes" or "no") during the 12-week (84-day) study. This length allows observation of 3 potential ovulatory cycles. The upper limit of a normal ovulatory cycle is 35 days, so to accommodate for this, documentation of ovulation with a progesterone test may extend to the end of week 14.', 'timeFrame': '12 weeks'}
- {'measure': 'Ovulation Frequency', 'description': 'Ovulation is the primary outcome can be expressed in according to frequency (nominal "0", "1", "2, or "3") during the 12-week (84-day) study. This length allows observation of 3 potential ovulatory cycles. The upper limit of a normal ovulatory cycle is 35 days, so to accommodate for this, documentation of ovulation with a progesterone test may extend to the end of week 14.', 'timeFrame': '12 weeks'}

Please estimate the sample size based on the assumption: 
The power calculation uses a 5% significance level and 80% power for comparing two proportions. A drop-out rate of 32% is also considered.
Sample size and power calculations
        Assuming no interactions between the two main effects as discussed earlier, the target sample size will be 240 participants (120 participants in the GLC group and 120 participants on oral medication). This is based on: a power calculation using a 5% significance level, 80% power comparing two proportions, and current knowledge of the average ovulation rates of lifestyle interventions and letrozole, our primary comparison. We explored a number of combinations of the ovulation rates from letrozole and lifestyle interventions and chose the most conservative estimate to ensure that our sample size was adequate, i.e., 91 in each group. By enrolling 120 participants in each group, we have allowed for a drop-out rate of 32%. TableÂ 1 describes the lowest and highest reported ovulation rates for letrozole and lifestyle interventions, the sample size required in each scenario comparing the two proportions, and the three highest sample sizes required from our calculations, accounting for the length of lifestyle intervention and the start dose of letrozole.Table 1Sample size calculation based on previous literatureRange of reportedovulation ratesLetrozole ovulation rateLifestyle ovulation rateTotal sample size neededLowest62%a38%b130Highest86%c67%d150Median70%50%182aLegro et al. [29]bPalomba et al. [36]cZeinalzadeh et al. [37]dKarimzadeh and Javedani [38]
        When calculating the sample size necessary to assess the effect of myo-inositol on ovulation rates, we reviewed the few published studies available acknowledging that these studies all had small sample size. One randomized controlled trial reported an ovulation rate of 70% when myo-inositol was given to women with PCOS versus a 21% ovulation rate in controls [24]. Similarly, another randomized controlled trial reported an ovulation rate of 65% using myo-inositol in PCOS [32]. Using these rates in a comparison of two proportions, a total sample size of 26 is needed, and easily covered by our original calculation above.