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. 2016 Apr 29;2016(4):CD001750. doi: 10.1002/14651858.CD001750.pub4

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
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
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
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.