OBJECTIVE: To assess the potential effect of intercessory prayer (IP) on pregnancy rates in women being treated with in vitro fertilization-embryo transfer (IVF-ET). STUDY DESIGN: Prospective, double-blind, randomized clinical trial in which patients and providers were not informed about the intervention. Statisticians and investigators were masked until all the data had been collected and clinical outcomes were known. The setting was an IVF-ET program at Cha Hospital, Seoul, Korea. IP was carried out by prayer groups in the United States, Canada and Australia. The investigators were at a tertiary medical center in the United States. The patients were 219 women aged 26-46 years who were consecutively treated with IVF-ET over a four-month period. Randomization was performed after stratification of variables in two groups: distant IP vs. no IP. The clinical pregnancy rates in the two groups were the main outcome measure. RESULTS: After clinical pregnancies were known, the data were unmasked to assess the effects of IP after assessment of multiple comparisons in a log-linear model. The IP group had a higher pregnancy rate as compared to the no-IP rate (50% vs. 26%, P = .0013). The IP group showed a higher implantation rate (16.3% vs. 8%, P = .0005). Observed effects were independent of clinical or laboratory providers and clinical variables. CONCLUSION: A statistically significant difference was observed for the effect of IP on the outcome of IVF-ET, though the data should be interpreted as preliminary.
RCT Entities:
OBJECTIVE: To assess the potential effect of intercessory prayer (IP) on pregnancy rates in women being treated with in vitro fertilization-embryo transfer (IVF-ET). STUDY DESIGN: Prospective, double-blind, randomized clinical trial in which patients and providers were not informed about the intervention. Statisticians and investigators were masked until all the data had been collected and clinical outcomes were known. The setting was an IVF-ET program at Cha Hospital, Seoul, Korea. IP was carried out by prayer groups in the United States, Canada and Australia. The investigators were at a tertiary medical center in the United States. The patients were 219 women aged 26-46 years who were consecutively treated with IVF-ET over a four-month period. Randomization was performed after stratification of variables in two groups: distant IP vs. no IP. The clinical pregnancy rates in the two groups were the main outcome measure. RESULTS: After clinical pregnancies were known, the data were unmasked to assess the effects of IP after assessment of multiple comparisons in a log-linear model. The IP group had a higher pregnancy rate as compared to the no-IP rate (50% vs. 26%, P = .0013). The IP group showed a higher implantation rate (16.3% vs. 8%, P = .0005). Observed effects were independent of clinical or laboratory providers and clinical variables. CONCLUSION: A statistically significant difference was observed for the effect of IP on the outcome of IVF-ET, though the data should be interpreted as preliminary.