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. |
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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. |
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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. |
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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. |