Ferraretti 2004.
Methods | Prospective, randomized study, single centre. Randomisation method: not stated. Power analysis: Study period: January 2002 to April 2004. Sample size: 1009. Conflicts of interest: not stated. |
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Participants | Normo‐ovulatory women with inadequate response on COS and no previous ovarian stimulation within 6 months, normal uterine cavity, presence of both ovaries, normal karyotypes in both partners. Age < 37 years. BMI < 27 kg/m2. AFC > 10. Baseline characteristics to compare: age and indication IVF. Exclusion criteria: not stated. |
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Interventions | Luteal started pituitary downregulation with an GnRH agonist. 150 IU rFSH was started for ovarian stimulation in patients < 30 years, 225 IU 30‐37, and 300 IU >= 38 years. Standard treatment: increasing the dosage of rFSH to 450 IU alone. Experimental treatment: rFSH in combination with 75‐150 IU rLH until ovulation triggering with HCG. |
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Outcomes | Primary endpoints: pregnancy rate (not defined) per embryo transfer, implantation rate (number of gestational sacs per total number of embryos transferred), live birth rate per started cycles. Secondary endpoints: rFSH dose used, mean number of oocytes, fertilisation rate, cleavage rate, number of cryopreserved oocytes for OHSS, number of fresh embryo transfer's, number of pregnancies after 2PN thawing, abortion rate. |
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Notes | BMI and duration of infertility not stated. Miscarriage rate not stated. Incidence of multiple pregnancies was not stated. The data the third group C is not included. 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 given on random sequence generation. |
Allocation concealment (selection bias) | Unclear risk | No information given 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 whether or not outcome assessors were blinded 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 | High risk | Proportions of withdrawals/losses to follow‐up were imbalanced between the two treatment groups (Group A: 0/54; Group B: 4/54) and analysis was not based on ITT. |
Selective reporting (reporting bias) | Low risk | Outcome measures were prespecified in the methods section. |
Other bias | Unclear risk | Insufficient information to make a conclusive judgement. |