Huirne 2006c.
Methods | Multicentre (8 IVF centres), parallel group study. Number of women recruited: 216. Number of women excluded: 34 (reasons not reported). Number of women randomized: 182 (91 in each group). Number of withdrawals: 22 (10 in intervention group: 1 due to hepatitis B, 1 due to non‐compliance, 1 due to personal reasons, 2 due to insufficient follicular response, 1 due to conversion to IUI, 1 due to absence of mature oocytes, 3 due to absence of viable embryos; 12 in control group: 2 due to spontaneous pregnancy, 3 due to failure of desensitisation, 1 due to personal reasons, 1 due to stimulation failure, 3 due to absence of 'mature' oocytes, 2 due to failure of fertilisation). Number of women analyzed: 182. |
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Participants | Country of authors: the Netherlands, Belgium, France and Austria. Inclusion criteria: regular IVF/ICSI indication, male partner with viable sperm in the ejaculate, aged 18‐39 years. Exclusion criteria: any previous ART cycles with < 3 oocytes or ≥ 3 consecutive ART cycles without a clinical pregnancy, any contraindication to ART, gonadotrophins or OCPs, significant systemic disease. Mean age ± SD: intervention group: 32.8 ± 3.8 years; control group: 32.2 ± 4.2 years. |
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Interventions | Intervention: COCP (ethinyl oestradiol 30 μg + levonorgestrel 150 μg daily), started within 5 days of onset of menses for 21‐28 days (stop on a Sunday) + r‐hFSH (150‐225 IU/day), started post‐treatment day 5 (= stimulation day 1) + GnRH antagonist (cetrorelix acetate 0.25 mg/day, SC), started stimulation day 6. Control: GnRH agonist (buserelin acetate 500 μg/day, SC), started cycle day 18‐22 (reducing dose to 200 μg/day when downregulation was achieved) + r‐hFSH (150‐225 IU/day), started when downregulation was achieved. After 5 days of r‐hFSH treatment, the dose could be adjusted by steps of 75 IU (maximal dose 450 IU/day), according to the ovarian response. Both rhFSH and GnRH analogues were continued until hCG injection, administered when the largest follicle reached a mean diameter ≥ 18 mm and ≥ 2 other follicles had a mean diameter ≥ 16 mm. |
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Outcomes |
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Notes | Power calculation performed: yes. ITT analysis performed: no. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "182 were randomly allocated to...", "The treatment assigned to each patient was determined according to a computer‐generated concealed randomization list. Randomization was performed by centre." |
Allocation concealment (selection bias) | Unclear risk | "Concealed randomization list," method not reported. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All women randomized were included in final analysis. |
Selective reporting (reporting bias) | Low risk | Data on all planned outcomes reported. |
Other bias | Low risk | No significant difference in baseline characteristics with regard to age, race, duration of infertility, cause of infertility, smoking habits, primary infertility, number of previous ART attempts, number of follicles, endometrial thickness, FSH levels and oestradiol levels. P value of BMI was 0.04. |