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. 2017 May 24;2017(5):CD005070. doi: 10.1002/14651858.CD005070.pub3

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.
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.
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.
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.
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
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.