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

Matorras 2009.

Methods Single centre, randomized, parallel group, comparative study.
Randomisation method: not stated.
Power analysis: power of 80% to detect a significant difference of 20% in the number of MII oocytes retrieved and provided for a significance level of 0.05. The resulting calculation required a total of 124 enrolled patients.
Study period: January 2005 and November 2006.
Sample size: 138.
Conflict of interests: not stated.
Participants Normo‐ovulatory women with an uterine cavity capable of sustaining a pregnancy and presence of both ovaries.
Age: between 35 and 39 years.
FSH: < 10 IU/L.
Exclusion criteria: (i) human immunodeficiency virus or hepatitis B virus/hepatitis C virus positive; (ii) clinically significant condition preventing them from undergoing gonadotrophin treatment; (iii) more than two previous assisted cycles; (iv) cancellation of two previous cycles; (v) cryopreserved embryos available from previous assisted reproduction treatment; (vi) unexplained gynaecological bleeding; (vii) polycystic ovary or an ovarian cyst of unknown aetiology; (viii) pregnancy contraindication; (ix) active substance abuse; (x) simultaneous participation in another trial or reentry in the current trial; and (xi) refusal or inability to comply with the procedures set forth in the protocol.
Baseline characteristics to compare: age, BMI, infertility duration, FSH, LH, oestradiol, no. previous children, tubal factor, male factor, endometriosis, mixed cause, unknown cause, no. of previous IVF/ICSI cycles, sperm parameters.
Interventions Luteal started pituitary downregulation with Gnrh‐agonist Decapeptyl 0.1 mg/day. When serum E2 < 30 pg/ml ovarian stimulation was started with 300‐450 IU rFSH, at a fixed‐dose until stimulation day 6. After randomization 150 IU rLH was administrated until ovulation triggering with hCG.
Outcomes Primary endpoint: number of metaphase II oocytes retrieved.
Secondary endpoints: Cancellation rate, fertilisation rate, rFSH dose used, number of embryo's obtained, biochemical, clinical pregnancy rate, implantation rate and live birth rate.
Notes Funding: This study was partially supported by a grant from Merck Farma y Química, SL, an affiliate of Merck, Darmstadt, Germany. The authors thank Hannah Wills and Carol Cooper of Caudex Medical (supported by Merck Serono, Geneva) for their editorial assistance.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated list.
Allocation concealment (selection bias) Low risk Sealed envelope.
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 Low risk Numbers of women analyzed at the end of study were the same as those randomized at the beginning.
Selective reporting (reporting bias) Low risk Outcome measures were prespecified in the methods section.
Other bias Low risk Baseline characteristics were similar between the two groups.