Hauzman 2013.
Methods | Parallel group study. Number of women randomized: 100 (50 in each group). Number of withdrawals: 16 (7 in intervention group; 9 in control group). Number of women analyzed: 100 (ITT analysis). |
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Participants | Country: Spain. Inclusion criteria: aged 18‐38 years, regular normo‐ovulatory menstrual cycles (26‐35 days), BMI < 30 kg/m2, normal cycle day 3 basal serum hormone levels (FSH < 10 IU/L and oestradiol < 60 pg/mL) and < 3 previous IVF/ICSI attempts. Exclusion criteria: previous ovarian surgery, low ovarian response (cancellation of cycle due to poor follicular development after ≥ 7 days of gonadotropin stimulation or < 5 oocytes retrieved) in previous IVF/ICSI cycle and PCOS. Mean age ± SD: intervention group: 33.9 ± 3.4 years; control group: 34.5 ± 3.1 years. Setting: single hospital clinic in Madrid, Spain. |
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Interventions | Intervention: COCP: (ethinyl oestradiol 30 μg + levonorgestrel 150 μg) on day 1 or 2 of cycle prior to IVF/ICSI and continued for 12‐16 days, with stimulation starting 5 days after stopping pretreatment. Control: (oestradiol valerate 4 mg/day (2 mg × 2)) from day 20 of menstrual cycle for 5‐12 days until the day before starting stimulation. In both groups, GnRH antagonist (ganirelix 0.25 mg/day) started when the leading follicle reached 13 mm in diameter and ovarian triggering performed with rhCG (250 μg) (when 2 leading follicles reached ≥ 17 mm mean diameter). |
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Outcomes | Primary:
Secondary:
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Notes | Power calculation for sample size: yes but not achieved because this was a single‐centre study. ITT analysis: yes. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random number list. |
Allocation concealment (selection bias) | Low risk | Consecutively numbered opaque envelopes. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Although personnel involved in data collection and data analysis blinded it was not reported whether other personnel and participants were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons for withdrawals and proportions of withdrawals were fairly balanced between groups and data were analyzed on the basis of ITT. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported. |
Other bias | Low risk | Groups balanced at baseline with respect to demographic characteristics. |