Blockeel 2012.
Methods | Parallel group study. Number of women randomized: 86 (44 in intervention group; 42 in control group). Number of withdrawals: 14 (9 in intervention group due to cyst development, protocol violation, insufficient ovarian response, did not undergo treatment, did not receive embryo transfer; 5 in control group due to insufficient ovarian response, did not receive embryo transfer). Number of women analyzed (for pregnancy outcome): 72 (35 in intervention group; 37 in control group). |
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Participants | Country: Belgium. Inclusion criteria: women aged ≤ 36 years, BMI 18‐29 kg/m2, underwent a first or second treatment cycle of IVF with ICSI, serum FSH on day 3 of the menstrual cycle < 12 IU/L, normal ultrasound scan regular ovulatory menstrual cycle of 21 to 35 days. Exclusion criteria: oocyte donors, women with endometriosis ≥ grade 3, endocrine or metabolic abnormalities, PCOS or previous history of poor ovarian response (defined as development of < 4 follicles in previous IVF or ICSI cycle). Mean age ± SD: intervention group: 29.2 ± 3.0 years; control group: 30.2 ± 3.0 years. Setting: assisted reproduction programme in Belgium. |
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Interventions | Intervention: oestradiol valerate (2 × 2 mg/day) during 6‐10 consecutive days (from cycle day 25 onwards) prior to start of rFSH stimulation so that the first day of stimulation occurred between Friday and Sunday. Control: no pretreatment; standard GnRH antagonist protocol. Both groups received rFSH (150 IU) and on day 6 of stimulation GnRH antagonist protocol (ganirelix 0.25 mg/day). |
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Outcomes | Primary:
Secondary:
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Notes | Power calculation: not reported. ITT analysis: not reported. Objective of the study was to assess the ability of oestradiol to control the oocyte retrieval of GnRH antagonist cycles prior to COS. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization list. |
Allocation concealment (selection bias) | Low risk | Consecutive sealed opaque envelopes. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Blinding not reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons for, and proportions of, withdrawals balanced between the 2 treatment groups and data were analyzed on the basis of ITT. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported, |
Other bias | Low risk | Groups comparable at baseline, |