Pezzuto 2010.
Methods | Prospective randomized study. Randomisation:computer‐generated randomization list. Power analysis: not stated. Study period: March 2004 to October 2007. Sample size: 80. Conflict of interests: No conflicts of interest. |
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Participants | Healty woman undergoing IVF, with a regular mens. cycle and a normal uterine cavity after hysteroscopy. Age: between 20 and 39 years. FSH: < 10 IU/L. Exclusion criteria: not stated. Baseline characteristics to compare: mean age, BMI, baseline serum FSH, baseline serum LH, number of tubal factors, male factors, unexplained factors and endometriosis. |
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Interventions | Long GnRH agonist protocol. Standard treatment: 14 days after downregulation with leuprorelin, ovarian stimulation was initiated only with rFSH 225 IU. Experimental treatment: at the same time stimulation was initiated with rFSH 225 IU associated with rLH 75 IU on cycle day 6 of stimulation. |
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Outcomes | Primary endpoint: oocytes quality, classified into four maturation stages depending on the maturity of the oocyte‐cumulus‐corona complex. Secondary endpoints: duration of stimulation, FSH dose, serum E2 levels, follicular fluid VEGF levels, fertilisation rate, pregnancy rate. |
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Notes | Funding: not stated, but the authors declare that they are alone responsible for the content and writing of the paper. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization list. |
Allocation concealment (selection bias) | Unclear risk | Not stated. |
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 | Non‐blinding of outcome assessors is not likely to affect the outcomes of interest as they are objectively assessed. |
Incomplete outcome data (attrition bias) All outcomes | High risk | The reported outcomes were not specified in the methods section. |
Selective reporting (reporting bias) | Low risk | No dropouts. |
Other bias | Low risk | Baseline characteristics similar between the two treatment groups. |