Large randomized controlled trials in infertility
Rui Wang, M.D., Ph.D.a, Zi-Jiang Chen, M.D., Ph.D.b,c,d, Lan N. Vuong, M.D., Ph.D.e, Richard S. Legro, M.D.f, Ben W. Mol, M.D., Ph.D.a and Jack Wilkinson, Ph.D.g
As the first paper in this series of Views and Reviews on randomized controlled trials (RCTs), we aim to provide the basics of RCTs in infertility research. In this paper, we discuss the need and ethical considerations of large trials in infertility research and important aspects to guarantee the quality of a trial, including protocols, registrations and monitoring, issues of study design and analysis, and reporting standards. Because most of the treatment effects we would like to study represent relatively small signal-to-noise ratios, large RCTs are required to provide sufficient power to answer these questions. Trial protocols, registrations, and monitoring facilitate the transparency of conduct, analysis, and reporting of the trial. Issues of trial design and analysis, such as nonblinding and misuse of the denominators, are common in published trials in this area and could be further improved. Finally, following the current reporting standard facilitates complete and transparent reporting, critical appraisal, and interpretation.
Randomized controlled trials, infertility, ethics, statistical analysis, reporting
Review Recombinant follicle-stimulating hormone and recombinant luteinizing hormone versus recombinant follicle-stimulating hormone alone during GnRH antagonist ovarian stimulation in patients aged ≥ 35 years: a randomized controlled trial
[ T.N.L. Vuong1,2,*, H.T. Phung2, and M.T. Ho2,3 ]
Does luteinizing hormone (LH) supplementation improve live birth rate after in vitro fertilization...
- Review Pessary Compared With Vaginal Progesterone for the Prevention of Preterm Birth in Women With Twin Pregnancies and Cervical Length Less Than 38 mm A Randomized Controlled Trial: In Reply [ Dang, Vinh Q. MD1; Pham, Toan D. BSc1;Nguyen, Linh K. MD1; Mol, Ben W. MD, PhD2 ]
Review Developing a core outcome set for future infertility research: an international consensus development study
[ J. M. N. Duffy a,b; H. AlAhwany,c; S. Bhattacharya,d; B. Collura,e; C. Curtis,f,g; J. L. H. Evers,h; R. G. Farquharson,i; S. Franik,j; L. C. Giudice,k,l; Y. Khalaf,m J. M. L. Knijnenburg,n; B. Leeners,o; R. S. Legro,p S. Lensen,q; J. C. Vazquez-Niebla,r; D. Mavrelos,s; B. W. J. Mol,t; C. Niederberger,u; E. H. Y. Ng,v,w; A. S. Otter,x; L. Puscasiu,y; S. Rautakallio-Hokkanen,z; S. Repping,aa; I. Sarris,a; J. L. Simpson,bb; A. Strandell,cc; C. Strawbridge,dd; H. L. Torrance,ee; A. Vail,ff M. van Wely,aa; M. A. Vercoe,gg; N. L. Vuong,hh; A. Y. Wang,ii; R. Wang,t; J. Wilkinson,ff; M. A. Youssef,jj; C. M. Farquhargg and the Core Outcome Measure for Infertility Trials (COMMIT) initiative,z. ]
Study Question: Can a core outcome set to standardize outcome selection, collection, and reporting ac...
Review The early luteal hormonal profile in IVF patients triggered with hCG
[ Vuong LN1,2,3, Ho TM2,3, Pham TD2,3, Ho VNA2,3, Andersen CY4, Humaidan P5,6,7 ]
What is the early luteal phase hormonal profile...
Review A protocol developing, disseminating and implementing a core outcome set for infertility
[ J.M.N. Duffy1,2,*, S. Bhattacharya3, C. Curtis4,5, J.L.H. Evers6, R.G. Farquharson7, S. Franik8, Y. Khalaf9, R.S. Legro10, S.Lensen11, B.W. Mol12, C. Niederberger13, E.H.Y. Ng14, S. Repping15, A. Strandell16, H.L. Torrance17, A. Vail18, M. van Wely15, N.L. Vuong19, A.Y. Wang20, R. Wang21, J. Wilkinson18, M.A. Youssef22, and C.M. Farquhar11, on behalf of COMMIT: Core Outcomes Measures for Infertility Trials ]
We aim to produce, disseminate and implement a core outcome set for future infertility research.<...