Hwang 2004.
Methods | RCT, single‐centre Part II trial | |
Participants | 60 PCOS infertile women undergoing IVF/ICSI Inclusion criteria: PCOS included: (i) chronic anovulation manifested by the symptoms of oligomenorrhoea (0.40 days per cycle), amenorrhoea or irregular menstrual cycle and confirmed by a basal body temperature chart or serum progesterone determination; (ii) ultrasonographic evidence of polycystic ovaries an enlarged ovary with > .10 peripherally located follicles of 3 – 8 mm diameter around a dense central stroma; and (iii) at least one of the two hormonal abnormalities (a) normal FSH concentration (3 – 10 mIU/ml) and elevated LH concentration ( .10 mIU/ml) or LH /FSH ratio .2; and (b) hyperandrogaenemia (serum testosterone concentrations .0.8 ng/ml). A diagnosis of congenital adrenal hyperplasia, Cushing’s syndrome, androgen‐producing tumours, hyperprolactinaemia and thyroid dysfunction were all excluded Exclusion criteria: Women older than 38 years or with serum FSH levels .12 mIU/ml. Baseline characteristics: age (years) 31.4 ± 3.5 vs 31.7 ± 3.7. Duration of infertility (years) 4.4 ± 1.9 vs 4.4 ± 1.6. BMI (kg/m2) 23.2 ± 2.8 vs 23.4 ± 2.9. Baseline FSH 5.8 ± 1.2 vs 5.4 ± 1.7 |
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Interventions |
GnRH antagonist: Diane‐35/day from day 5 of the cycle for 21 days + cetrorelix acetate was then initiated with a single dose of 0.25 mg administered SC + from day 4 to day 9, cetrorelix acetate was reduced to 0.125 mg/day + 150 IU of hMG (Pergonal) every day. The dose of cetrorelix acetate was increased to 0.25 mg/day from day 10 until the day before hCG (Pregnyl; NY Organon) injection, and the dose of HMG (Fixed)
GnRH agonist: GnRH agonist long protocol. A GnRH agonist, buserelin acetate (Supremon), 500mg/day was administered from day 3 of induced or spontaneous menstruation. After 14 days of buserelin injection, buserelin was continued until the day of hCG injection, while the dosage was decreased to 250 mg/day at the beginning of hMG administration + 150 IU/day hMG was prescribed for six days beginning from the day of ensuing pituitary down‐regulation Oocyte maturation triggering: hCG, 10,000 IU, was administered IM when at least two follicles reached 18 mm in diameter with adequate E2 response Oocyte retrieval: was performed 36 hrs later Embryo transfer: was performed three days after oocyte recovery Luteal phase support: 600 mg of vaginally administered micronised progesterone (Utrogestan) daily starting from the day after oocyte retrieval Follow up: clinical pregnancy was defined as a visible fetal heart beat on ultrasonography at seven weeks of gestation |
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Outcomes |
The primary outcome measures: fertilisation, pregnancy and implantation rates The secondary outcome measures: serum LH and testosterone status upon starting and during HMG administration, and the total days of injection |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated block randomisation numbers with a block size of 10 |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
Blinding (performance bias and detection bias) All outcomes | Low risk | The laboratory staff were blinded to the stimulation protocol |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data, however LBR not addressed by the study |
Selective reporting (reporting bias) | Low risk | The study protocol was not available, but it is clear that the published reports included most expected outcomes |
Other bias | Low risk | The study appears to be free from other sources of bias. |