Olive, D. L. (1986). Analysis of clinical fertility trials: a methodologic review. Fertility and Sterility, 45(2), 157-171. https://doi.org/10.1016/s0015-0282(16)49148-x
Olive DL. Analysis of clinical fertility trials: a methodologic review. Fertil Steril. 1986;45(2):157-171. doi:10.1016/s0015-0282(16)49148-x
Olive, D. L. "Analysis of clinical fertility trials: a methodologic review." Fertility and Sterility, vol. 45, no. 2, 1986, pp. 157-171.
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University of Arkansas for Medical Sciences00xcryt71
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RRM Academy Synopsis
Fertility trials without a control group can overstate success
A 1986 review examined how fertility studies are set up. It drew on psychiatry, liver surgery, and infertility trials from one journal. Uncontrolled psychiatry and liver-surgery studies reported success far more often than controlled ones.
Key Findings
In a review of 52 published uncontrolled trials in psychiatry, 85% reported a therapeutic success. Only 25% of 20 controlled trials did.
Among 53 published studies of a liver-shunt surgery, 75% of the 32 uncontrolled studies reached a strongly favorable conclusion. None of the 6 well-controlled trials did.
Among trials in four sampled years of one journal, 27 came in 1983, more than the other three years combined; only 3 were experimental and 40% had no control group.
Leridon and Spira, cited by the author, projected that among couples unable to conceive for 3 years, pregnancy in the fourth year could be as high as 41% to 48%.
Reviewing 50 non-IVF fertility trials from five later journal volumes, only 15 used life-table analysis; of those, 5 ran no further statistical test.
Interpretation
This methods commentary reviewed how fertility studies are designed and analyzed, comparing psychiatry and liver-shunt surgery trials to show how a missing control group inflates reported success. Uncontrolled studies in both fields reported strong success far more often than controlled studies did. The paper explains why the way a pregnancy rate is calculated, and whether a study has a control group, changes how much its reported success can be trusted. The findings support designing fertility studies with control groups and life-table analysis.
RRM Context
This paper predates restorative reproductive medicine (RRM) by decades, but its lessons still apply. RRM outcome studies increasingly report pregnancy over time using life tables, a shift this paper argued for. The author cites Leridon and Spira: as many as 41% to 48% of long-infertile couples conceive on their own in the fourth year, with no treatment. A treatment's raw success number means little without a comparison group.
Our editorial summary of this paper, not the article's abstract.
Research Methods › Study Design › Randomized Controlled Trials
PMID 3512311 3512311 DOI 10.1016/s0015-0282(16)49148-x 10.1016/s0015-0282(16)49148-x Olive et al. 1986, Olive 1986
Keywords
Actuarial Analysis/methods, Clinical Trials As Topic/methods, Female, Humans, Infertility/therapy, Male, Pregnancy, Random Allocation, Research Design, Statistics As Topic
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