Ye 2009.
Methods | Parallel group study. Number of women randomized: 220 (109 in intervention group; 111 in control group). Number of withdrawals: none reported. Number of women analyzed: 208 cycles (103 in intervention group; 105 in control group) and numbers of cycles were equivalent to numbers of participants. |
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Participants | Country: China. Inclusion criteria: aged 25‐35 years; BMI 18‐25 kg/m2; number of previous IVF cycles < 3, and no previous poor response to ovarian stimulation (poor ovarian response characterised by cancellation of the cycle due to either poor follicular development or ≤ 4 cumulus‐oocyte‐complexes collected at oocyte retrieval); normal ovulatory cycles (25‐35 days); both ovaries present and normal uterus; no hormone therapy within the past 3 months; no current or past diseases affecting ovaries, gonadotrophin, sex steroid secretion, clearance or excretion. Exclusion criteria: not explicitly reported. Age range: 25‐35 years. Setting: IVF centre, China. |
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Interventions | Intervention: oral oestradiol valerate (4 mg/day) preceding the IVF cycle from day 21 until day 2 of next cycle before GnRH antagonist protocol. Control: standard long GnRH agonist protocol. |
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Outcomes |
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Notes | Outcomes measured as per 'embryo transfer cycle' but numbers of cycles transferred were equivalent to numbers of women randomized. Power calculation for sample size: not reported. ITT analysis: not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Randomization allocation sequence was generated from a table of computer‐generated random numbers." |
Allocation concealment (selection bias) | Unclear risk | Not reported. |
Blinding (performance bias and detection bias) All outcomes | High risk | "This study was not blind." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals reported, cycle cancellation (number of cycles were equivalent to numbers of women randomized) similar between groups. |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported. |
Other bias | Low risk | Groups comparable at baseline with respect to demographic characteristics. |
17‐βE2: 17‐beta oestradiol; AMH: anti‐mullerian hormone; BMI: body mass index; COCP: combined oral contraceptive pill; COH: controlled ovarian hyperstimulation; COS: controlled ovarian stimulation; FSH: follicle‐stimulating hormone; rFSH: recombinant follicle‐stimulating hormone; GnRH: gonadotrophin‐releasing hormone; GnRHa: gonadotrophin‐releasing hormone analogue; hMG: human menopausal gonadotrophin; IM: intramuscular; ITT: intention to treat; IU: international unit; IUI: intrauterine insemination; IVF: in vitro fertilisation; IVF‐ET: in vitro fertilisation with embryo transfer; LH: luteinising hormone; OCP: oral contraceptive pill; OHSS: ovarian hyperstimulation syndrome; PCOS: polycystic ovary syndrome; PO: per os (oral); rhCG: recombinant human chorionic gonadotropin; SC: subcutaneous; SD: standard deviation; SEM: standardized mean difference; TESE: testicular epididymal sperm extraction; WHO: World Health Organization.