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 |
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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 |