IVF with preimplantation genetic screening, a promising new treatment with unexpectedly negative health outcomes: the Hippocratic role of Data Monitoring Committees
Authors: Ankum, Willem M.; Reitsma, Johannes B.; Offringa, Martin
Source: Human Reproduction, Volume 23, Number 1, 13 January 2008 , pp. 1-3(3)
Publisher: Oxford University Press
Abstract:A recently published randomized controlled trial showed preimplantation genetic screening (PGS) as part of an IVF programme to reduce ongoing pregnancy rates by 1/3 in comparison to the control group without PGS: rate ratio (RR) 0.69 (0.510.93), P 0.01. A masked interim analysis already showed significant differences between treatment arms: RR 0.58 (0.350.94), P 0.02. Despite this finding, the trial's Data Monitoring Committee decided not to stop, but to continue the trial. This paper argues why this decision was sound, since it was based on (i) explicit statistical criteria and (ii) the trade-off between risks and benefits for current and future IVF patients. The trial's findings confront the medical community once again with the general problem of new technologies being implemented without randomized evidence of effectiveness.
Document Type: Opinion
Publication date: 13 January 2008
- Human Reproduction features full-length, peer-reviewed papers reporting original research, clinical case histories, as well as opinions and debates on topical issues. Papers published cover the scientific and medical aspects of reproductive physiology and pathology, endocrinology, andrology, gonad function, gametogenesis, fertilization, embryo development, implantation, pregnancy, genetics, genetic diagnosis, oncology, infectious disease, surgery, contraception, infertility treatment, psychology, ethics and social issues. The highest scientific and editorial standard is maintained throughout the journal along with a rapid rate of publication.