Allegra 2011.
Methods | Prospective randomised study, single centre. Randomisation method: not stated. Power analysis: not stated. Study period: not stated. Sample size: 102 women. Conflict of interest: not stated. |
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Participants | Normagonadotropic women undergoing ICSI. Age 38 to 44 years. FSH ≥ 9 mIU/ml. Exclusion criteria: basal FSH ≥ 16 mIU/ml, women age ≥ 44 years, severe endometriosis, severe male factor, secondary infertility ≤ 3 years. Baseline characteristics to compare: age, BMI, menstrual cycle length, antral follicle count. |
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Interventions | Luteal started pituitary downregulation with GnRH agonist. The supplementation of the luteal phase was assured by the administration of progesterone. Standard treatment: rFSH alone, 225‐450 IU daily. Experimental treatment: rFSH, 225‐450 IU daily and rLH 75 IU daily from the day in which at least one follicle ≥ 14 mm was detected. |
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Outcomes | Primary endpoint:
Secondary endpoints:
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Notes | Abstract only. Funding: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information was reported on random sequence generation. |
Allocation concealment (selection bias) | Unclear risk | No information was reported on allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Non‐blinding is not likely to affect the outcomes of interest as they are objectively assessed. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | No information was provided on blinding of outcome assessors but non‐blinding of outcome assessment is not likely to affect outcomes of interest as they are objectively assessed. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Although dropouts and reasons for withdrawals were given, proportions were not and reasons were not uniform between treatment groups and analysis was not on ITT basis. |
Selective reporting (reporting bias) | Unclear risk | Methods section not detailed enough to make conclusive judgement. |
Other bias | Low risk | Baseline demographic characteristics were similar between the two treatment groups. |