Franco Jr 2003.
Methods | Parallel group study. Number of women recruited: 22. Number of women randomized: 22 (16 in intervention group; 6 in control group). Number of withdrawals: 1 (both in intervention group, due to spontaneous pregnancies). Number of women analyzed: 20. |
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Participants | Country of authors: Brazil. Inclusion criteria: women without specific ovulatory dysfunction, aged ≤ 37 years, who would be submitted to ovarian stimulation. Exclusion criteria: not reported. Mean age ± SD: intervention group: 32.2 ± 2.1 years; control group: 31.8 ± 1.9 years. |
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Interventions | Intervention: oestradiol valerate (4 mg/day) for 14 days, started cycle day 21 + rFSH (150‐300 IU) (fixed dose for 5 days), started post‐treatment day 1 + GnRH antagonist (ganirelix acetate 0.25 mg/day), started when follicular diameter ≥ 15 mm. Control: GnRH agonist (nafarelin acetate 200 μg twice daily, nasal), started cycle day 21 + rFSH (150‐300 IU) (fixed dose for 5 days), started stimulation day 14. Both rFSH and GnRH analogues continued until hCG injection (5000‐10,000 IU), administered when ≥ 2 follicles were ≥ 17 mm in diameter. |
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Outcomes |
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Notes | Power calculation performed: no. ITT analysis performed: no |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation by drawing lots after constructing a table of distribution. 2:1 randomization (intervention:control). |
Allocation concealment (selection bias) | High risk | After drawing lots, clinicians and participants could see in the table to which treatment they were assigned to. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Insufficient information to make a conclusive judgement. |
Incomplete outcome data (attrition bias) All outcomes | High risk | There was imbalance in the proportions of withdrawals between the 2 groups and data analyzed on the basis of ITT. |
Selective reporting (reporting bias) | High risk | All planned outcomes not reported. |
Other bias | Low risk | No significant difference in baseline characteristics with regard to age. |