Tarlatzis 2006.
Methods | Prospective, randomized, placebo‐controlled trial.
Randomisation: by means of a computer programme generated by Serono International S.A.
Power analysis: In order to detect a difference of 2.5 in the mean number of MII oocytes between the two groups a 100 patients were needed. Study period: Not stated. Sample size: 123 patients. Conflict of interests: Not stated. |
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Participants | Patients with a normal uterus and two ovaries with an indication for IVF or ICSI.
Age: between 18 and 37 years. FSH: maximum 12 IU/l. Exclusion criteria: previous poor respondents. Baseline characteristics to compare: mean age, BMI, duration of infertility, primary/secondary infertility, cause of infertility: tubal factor, male factor, Semen characteristics: normal, abnormal. |
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Interventions | Follicular started, pituitary downregulation with a GnRH agonist buserelin 200 mg subcutaneous until serum E2 < 200 pmol/l and no follicle > 15 mm. 150 IU rFSH was started adjusted if necessary on stimulation day 5. Once the leading follicle reached > 14 mm, patients were randomized. Standard treatment: r‐hLH (lutropin alfa; Luveris, Laboratoires Serono S.A.), 75 IU subcutaneously for a maximum of 10 days. Experimental treatment: placebo. |
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Outcomes | Primary endpoint: mean number of MII oocytes. Secondary endpoints: duration of stimulation, the dose of rFSH required for stimulation, the number of fertilised embryo's, the number of cleaved oocytes, the pregnancy rate and live birth rate. | |
Notes | No data on cryo‐survival. No data on multiple pregnancies. All IVF cycles were converted to ICSI. Funding: this study was supported by Serono. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated. |
Allocation concealment (selection bias) | Low risk | Adequate, sealed envelopes. |
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 reported on blinding of outcome assessment although non‐blinding of outcome assessment is not likely to affect the outcomes of interest as they are objectively assessed. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up; ITT analysis. |
Selective reporting (reporting bias) | Low risk | Outcome measures were specified in the methods section. |
Other bias | Low risk | Baseline demographic characteristics similar between the two treatment groups. |