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Review
. 2011 Jun 30;95(8):2527-30.
doi: 10.1016/j.fertnstert.2011.02.040. Epub 2011 Mar 24.

Incomplete and inconsistent reporting of maternal and fetal outcomes in infertility treatment trials

Affiliations
Review

Incomplete and inconsistent reporting of maternal and fetal outcomes in infertility treatment trials

Lisa Dapuzzo et al. Fertil Steril. .

Abstract

Pregnancy outcomes and adverse outcomes in infertility trials are reported to varying extents; for example, 35% of clinical trials reported no information on pregnancy loss, only 43% reported adverse events during the preconception treatment period, and only 7% reported any serious adverse events. Incomplete reporting limits the value of these studies in counseling patients on the risk-benefit ratio of treatment to themselves and their infants.

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Conflict of interest statement

Conflicts of Interest: The authors report no conflicts of interest.

Figures

Figure 1
Figure 1
Flow chart of articles retrieved from the top impact journals in Obstetrics and Gynecology for this review.
Figure 2
Figure 2
The proportion of articles reporting the events of interest, e.g., pregnancy and live birth, multiple pregnancy, adverse events, etc. was calculated. with exact 95% confidence limits. Conception was defined as any positive serum hCG level, a pregnancy was defined as an intrauterine pregnancy with fetal heart motion as determined by transvaginal ultrasound, and live birth was defined as delivery of any viable infant. (IUP = intrauterine pregnancy)

References

    1. Legro RS, Myers E. Surrogate end-points or primary outcomes in clinical trials in women with polycystic ovary syndrome? Hum Reprod. 2004;19:1697–1704. - PubMed
    1. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Lancet. 2001;357:1191–1194. - PubMed
    1. Johnson NP. No more surrogate end-points in randomised trials: The PCOSMIC trial protocol for women with polycystic ovary syndrome using metformin for infertility with clomiphene. Aust N Z J Obstet Gynaecol. 2006;46:141–145. - PubMed
    1. Min JK, Breheny SA, MacLachlan V, Healy DL. What is the most relevant standard of success in assisted reproduction? The singleton, term gestation, live birth rate per cycle initiated: the BESST endpoint for assisted reproduction. Hum Reprod. 2004;19:3–7. - PubMed
    1. Legro RS, Barnhart HX, Schlaff WD, Carr BR, Diamond MP, Carson SA, et al. Clomiphene, metformin, or both for infertility in the polycystic ovary syndrome. N Engl J Med. 2007;356:551–566. - PubMed

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