Kim 2011.
Methods | Parallel group study. Number of women randomized: 120. Number of withdrawals: 0. Number of women analyzed: 120. Duration of study: 1 cycle. |
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Participants | Country of authors: South Korea. 120 poor responders (repeated day 3 levels of FSH > 8.5 mIU/mL or antral follicle count ≤ 5, or both). 40 in each group. Inclusion criteria: not clearly stated. Exclusion criteria: PCOS (Rotterdam criteria). Mean age ± SD: group 1: 36.7 ± 3.1 years; group 2: 35.9 ± 2.8 years; group 3: 36.4 ± 3.3 years. Setting: university‐based infertility clinic, Seoul. Korea. |
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Interventions | Pretreatment was ethinyl oestradiol 0.03 mg and levonorgestrel 0,15 mg for 21 days in the cycle preceding COS. Group 1: GnRH antagonist multiple dose protocol after OCP pretreatment. Ovarian stimulation started 5 days after OCP discontinued using rFSH (225 IU/day, dose adjusted every 3‐4 days). Cerotide (0.25 mg) started when lead follicle was 14 mm diameter and continued until day of hCG injection. Group 2 GnRH antagonist multiple dose protocol without OCP pretreatment. Ovarian stimulation started on cycle day 3 using rFSH (225 IU/day, dose adjusted every 3‐4 days). Cerotide (0.25 mg) started when lead follicle was 14 mm diameter and continued until day of hCG injection. Group 3: GnRH agonist luteal low‐dose long protocol without OCP pretreatment. Daily injection of decapeptyl (0.1 mg) started from mid‐luteal phase and continued until menses followed by a dose reduction to 0.05 mg daily and continued until day of hCG injection. |
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Outcomes | Primary:
Secondary:
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Notes | Power calculation: yes. ITT analysis: yes. Earlier publications were Kim 2005 and Kim 2009. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Computer generated lists." |
Allocation concealment (selection bias) | Unclear risk | Quote: "The sequence of allocation to the three groups was provided to the investigating physicians." |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | In groups 1 and 3 there were no losses, withdrawals or cancellations. In group 2, 1 cycle was cancelled before embryo transfer; all women randomized were included in data analysis. |
Selective reporting (reporting bias) | Low risk | All outcomes listed were reported although multiple pregnancy was reported it is not listed a priori. |
Other bias | Low risk | Groups similar at baseline with respect to demographic characteristics. |