Hwang 2004.
Methods | Single‐centre, parallel group study. Number of women recruited: 60. Number of women excluded: 4 (2 refused to participate, 2 did not meet inclusion criteria). Number of women randomized: 56 (27 in intervention group; 29 in control group). Number of withdrawals: 7 (2 in intervention group: 1 due to poor ovarian response, 1 due to personal reasons; 5 in control group: 2 due to inadequate ovarian response, 3 due to risk of severe OHSS). Number of women analyzed: 49. |
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Participants | Country: Taiwan. Inclusion criteria: PCOS. Exclusion criteria: diagnosis of congenital adrenal hyperplasia, Cushing's syndrome, androgen‐producing tumours, hyperprolactinaemia or thyroid dysfunction; aged > 38 years; serum FSH levels > 12 mIU/mL. Mean age ± SD: intervention group: 31.4 ± 3.5 years; control group: 31.7 ± 3.7 years |
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Interventions | Intervention: COCP (Diane‐35, oral) on cycle days 5‐25 for 3 consecutive cycles + GnRH antagonist (cetrorelix acetate 0.25 mg single dose, SC on post‐treatment day 3; 0.125 mg/day on post‐treatment days 4‐9; and 0.25 mg/day started post‐treatment day 10 + hMG 150 IU/day), started post‐treatment day 4. Control: GnRH agonist (buserelin acetate 500 μg/day, long protocol) started day 3 of induced or spontaneous menstruation, and 250 μg/day started day of ensuing pituitary downregulation + hMG (150 IU/day) for 6 days started when pituitary downregulation was achieved. hMG dose can be adjusted according to woman's follicular response. Pituitary downregulation achieved when serum oestradiol levels < 50 pg/mL and there was an absence of ovarian cysts > 10 mm in diameter. Both GnRH analogues and hMG were continued until hCG injection (10,000 IU, IM), administered when ≥ 2 follicles reached 18 mm in diameter with adequate oestradiol response. |
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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: "Randomization was done by opening sealed envelopes containing computer‐generated block randomization numbers with a block size of 10." |
Allocation concealment (selection bias) | Low risk | Sealed envelopes. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Quote: "The laboratory staff were blinded to the stimulation protocol." Unclear if treating physicians were blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Reasons for withdrawals and proportions of withdrawals were not balanced between groups and data were not analyzed on the basis of ITT. |
Selective reporting (reporting bias) | Low risk | Data on all planned outcomes were reported. |
Other bias | Low risk | No significant difference in baseline characteristics with regard to age, duration of infertility, BMI and hormonal levels. |