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. 2010 Jan 20;2010(1):CD000057. doi: 10.1002/14651858.CD000057.pub2

Fisch 1989.

Methods Randomised, double‐blind trial. Treatment allocated by one centre using a computer‐generated randomisation list. No details of allocation concealment. Four‐arm, parallel factorial design assessing CC and hCG luteal phase support. Multicentre trial in five Canadian University centres. Attrition: 148/177 women were analysed, details in quality table
Participants Canadian study of women attending University Centres. Mean female age 30 (range 20‐41) years, mean duration of infertility 4.3±1.4 years (range 2‐12). Primary subfertility only of 2 years or greater. Ovulation confirmed by BBT, luteal serum progesterone or endometrial biopsy; tubal status normal on laparoscopy; sperm normal by WHO standards. Endometriosis patients excluded. n= 177 couples enrolled, 148 included in analysis
Interventions Clomiphene 100 mg in 2x tablets taken orally on cycle days 5 to 9 followed by saline injections IM on cycle days 19,22,25 and 28 (n=37) 
 versus 
 Clomiphene 100 mg in 2x tablets taken orally on cycle days 5 to 9 followed by hCG injections IM 5000 IU on cycle days 19,22,25 and 28 (n=39) 
 versus 
 Placebo 2x tablets taken orally on cycle days 5 to 9 followed by saline injections IM on cycle days 19,22,25 and 28 (n=36) 
 versus 
 Placebo 2x tablets taken orally on cycle days 5 to 9 followed by hCG injections IM 5000 IU on cycle days 19,22,25 and 28 (n=36)
Interventions were given for 4 consecutive cycles 
 After 6 months of follow up women were offered the IVF programme
Outcomes Pregnancy confirmed by ultrasound evidence of fetal heart activity or trophoblast on pathological examination, chemical pregnancies excluded. Miscarriage, still birth and multiple pregnancies
Notes Couples were followed for 6 consecutive cycles post‐treatment
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Low risk Treatment allocated by one centre using a computer‐generated randomisation list
Allocation concealment? Unclear risk B ‐ unclear, co‐ordination of codes and drug distribution from one centre but no details of how concealment was maintained
Blinding? 
 All outcomes Low risk Double‐blind double dummy trial
Incomplete outcome data addressed? 
 All outcomes Low risk 177 women enrolled, 22 were excluded for incomplete data or missed medication (n=11), 7 dropped out, 2 had endometriosis found on review and 2 were found to have secondary infertility. Seven pregnancies occurred after enrolment but before study medication leaving 148 women for analysis
Free of selective reporting? High risk Did not report on live birth