Fernandez‐Ramirez 2006.
Methods | Prospective, randomized study, single centre. Randomisation method: Power analysis: not stated. Study period: between January and June 2006. Sample size: 34 patients. Conflict of interests: not stated. |
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Participants | Women in good health with a regular menstrual cycle and both ovaries present. Age: < 37 years. BMI < 30. Exclusion criteria: known HIV, HBV or HCV, prolactin serum level of > 25 ng/ml, suffering any clinically significant systemic disease mind, hypothalamic or pituitary tumour, ovarian, uterine or breast cancer, endocrine disease and/or medical, biochemical or hematological disorders, to have followed more than 3 previous cycles of assisted reproduction, have cryopreserved embryos with the same partner, presence of vaginal bleeding of unknown cause, PCOS, known allergy to gonadotropins, drug abuse, drug abuse or alcoholism in the past five years. Baseline characteristics to compare: age, BMI, years infertility, cause of infertility. |
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Interventions | Short pituitary downregulation with GnRH antagonist cetrorelix. Standard treatment: on second or third day of the menstrual cycle 300 rFSH or 400 rFSH was started. Experimental treatment: rFSH and 75 IU rLH twice daily and when the leading follicle reached 14 mm. |
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Outcomes | Primary endpoint: not stated. Secondary endpoints: number of punctured follicles oocytes, number of metaphases II, IVF fertilisation rate and ICSI fertilisation rate, progesterone levels, E2, FSH, LH. |
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Notes | Article in Spanish. Funding: this study is a part of Serono Laboratories |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information was given on random sequence generation. |
Allocation concealment (selection bias) | Unclear risk | No information was 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 | 29.4% cancellation rate. |
Selective reporting (reporting bias) | High risk | Outcome measures were not prespecified in the methods section. |
Other bias | Low risk | Baseline demographic characteristics similar between the two treatment groups. |