Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT): modifying the CONSORT statement
TLDR
It is proposed to track the change in quality that these guidelines may produce in published trials testing infertility treatment to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and couples.Abstract:
Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public (such as live birth) nor on the harms, including maternal risks during pregnancy and fetal anomalies. This is complicated by the multiple participants in infertility trials which may include a woman (mother), a man (father), and result in a third individual if successful, their offspring (child), who is also the desired outcome of treatment. The primary outcome of interest and many adverse events occur after cessation of infertility treatment and during pregnancy and the puerperium, which create a unique burden of follow-up for clinical trial investigators and participants. In 2013, because of the inconsistencies in trial reporting and the unique aspects of infertility trials not adequately addressed by existing Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modifications to the CONSORT checklist to improve the quality of reporting of clinical trials testing infertility treatment. The consensus group recommended that the preferred primary outcome of all infertility trials is live birth (defined as any delivery of a live infant ≥20 weeks gestations) or cumulative live birth, defined as the live birth per women over a defined time period (or number of treatment cycles). In addition, harms to all participants should be systematically collected and reported, including during the intervention, any resulting pregnancy, and during the neonatal period. Routine information should be collected and reported on both male and female participants in the trial. We propose to track the change in quality that these guidelines may produce in published trials testing infertility treatments. Our ultimate goal is to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and couples.read more
Citations
More filters
Journal ArticleDOI
The International Glossary on Infertility and Fertility Care, 2017
Fernando Zegers-Hochschild,G. David Adamson,Silke Dyer,Catherine Racowsky,Jacques de Mouzon,Rebecca Z. Sokol,Laura Rienzi,Arne Sunde,Lone Schmidt,Ian D. Cooke,Joe Leigh Simpson,Sheryl van der Poel +11 more
TL;DR: A consensus-based and evidence-driven set of 283 terminologies used in infertility and fertility care was generated to harmonize communication among health professionals and scientists as well as the lay public, patients and policy makers.
Journal ArticleDOI
The International Glossary on Infertility and Fertility Care, 2017
Fernando Zegers-Hochschild,G. David Adamson,Silke Dyer,Catherine Racowsky,Jacques de Mouzon,Rebecca Z. Sokol,Laura Rienzi,Arne Sunde,Lone Schmidt,Ian D. Cooke,Joe Leigh Simpson,Sheryl van der Poel +11 more
TL;DR: A consensus-based and evidence-driven set of 283 terminologies used in infertility and fertility care was generated to harmonize communication among health professionals and scientists as well as the lay public, patients and policy makers.
Journal ArticleDOI
Fresh versus Frozen Embryos for Infertility in the Polycystic Ovary Syndrome
Zi-Jiang Chen,Zi-Jiang Chen,Yuhua Shi,Yun Sun,Bo Zhang,Xiaoyan Liang,Yunxia Cao,Jing Yang,Jiayin Liu,Daimin Wei,Ning Weng,Li Feng Tian,Cuifang Hao,Dongzi Yang,Feng Zhou,Juanzi Shi,Yongle Xu,Jing Li,Junhao Yan,Yingying Qin,Han Zhao,Heping Zhang,Richard S. Legro +22 more
TL;DR: Among infertile women with the polycystic ovary syndrome, frozen-embryo transfer was associated with a higher rate of live birth, a lower risk of the ovarian hyperstimulation syndrome, and a higher risk of preeclampsia after the first transfer than was fresh-embyo transfer.
Journal ArticleDOI
Pregnancy complications in women with polycystic ovary syndrome
Stefano Palomba,Marlieke A. de Wilde,Angela Falbo,Maria P.H. Koster,Giovanni Battista La Sala,Bart C.J.M. Fauser +5 more
TL;DR: The strategies for prevention and management of pregnancy complications in women with PCOS, and whether long-term health of these women is influenced, and to what extent, by pregnancy and/or pregnancy complications, remain to be elucidated are summarized.
Journal ArticleDOI
Randomized trial of a lifestyle program in obese infertile women
Meike Mutsaerts,Anne M. van Oers,Henk Groen,Jan M. Burggraaff,Walter K. H. Kuchenbecker,Denise A. M. Perquin,Carolien A.M. Koks,Ron J. T. van Golde,Eugenie M. Kaaijk,Jaap M. Schierbeek,G.J.E. Oosterhuis,Frank J. M. Broekmans,Wanda J. E. Bemelmans,Cornelis B. Lambalk,M. F. G. Verberg,Fulco van der Veen,Nicole F. Klijn,Patricia E. A. M. Mercelina,Yvonne M. van Kasteren,Annemiek W. Nap,Egbert A. Brinkhuis,Niels E. A. Vogel,Robert J. A. B. Mulder,Ed T. C. M. Gondrie,Jan Bruin,J. Marko Sikkema,Mathieu H. G. de Greef,Mathieu H. G. de Greef,Nancy C. W. ter Bogt,Jolande A. Land,Ben W.J. Mol,Annemieke Hoek +31 more
TL;DR: In this paper, the authors randomly assigned infertile women with a body-mass index (the weight in kilograms divided by the square of the height in meters) of 29 or higher to a 6-month lifestyle intervention preceding treatment for infertility or to prompt treatment for fertility.
References
More filters
Journal ArticleDOI
CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
TL;DR: The Consort 2010 Statement as discussed by the authors has been used worldwide to improve the reporting of randomised controlled trials and has been updated by Schulz et al. in 2010, based on new methodological evidence and accumulating experience.
Journal ArticleDOI
International Statistical Classification of Diseases and Related Health Problems
TL;DR: There is substantial global variation in the relative burden of stroke compared with IHD, and the disproportionate burden from stroke for many lower-income countries suggests that distinct interventions may be required.
Journal ArticleDOI
International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy.
Pregnancy Study Groups Consensus Panel,Boyd E. Metzger,Steven G. Gabbe,Bengt Persson,Thomas A. Buchanan,Patrick A Catalano,Peter Damm,Alan R. Dyer,Alberto de Leiva,Moshe Hod,John L Kitzmiler,Lynn P. Lowe,H. David McIntyre,Jeremy Oats,Yasue Omori,Maria Inês Schmidt +15 more
TL;DR: The Brazilian study provided evidence that adverse perinatal outcomes are associated with levels of maternal glycemia below those diagnostic of GDM by American Diabetes Association or World Health Organization criteria, however, the results were potentially confounded by the treatment of G DM.
Journal ArticleDOI
CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials.
TL;DR: The CONSORT (Consolidated Standards of Reporting Trials) statement as discussed by the authors is used worldwide to improve the reporting of randomized, controlled trials. Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience.
Journal ArticleDOI
Effects of Torcetrapib in Patients at High Risk for Coronary Events
Philip J. Barter,Mark J. Caulfield,Mats Eriksson,Scott M. Grundy,John J.P. Kastelein,Michel Komajda,Jose Lopez-Sendon,Lori Mosca,Jean-Claude Tardif,David D. Waters,Charles L. Shear,James H. Revkin,Kevin A. Buhr,Marian R. Fisher,Alan R. Tall,Bryan Brewer +15 more
TL;DR: Although there was evidence of an off-target effect of torcetrapib, it cannot rule out adverse effects related to CETP inhibition, and the trial was terminated prematurely because of an increased risk of death and cardiac events.