TY - JOUR
T1 - Improving the reporting of Clinical trials of infertility treatments (IMPRINT)
T2 - Modifying the CONSORT statement
AU - Legro, Richard S.
AU - Wu, Xiaoke
AU - Barnhart, Kurt T.
AU - Farquhar, Cynthia
AU - Fauser, Bart C.J.M.
AU - Mol, Ben
N1 - Funding Information:
This study, participants' travel and their attendance to the meeting was funded from by the National Clinical Trial Base in TCM, National Key Discipline/Specialty, Longjiang Scholars' Program, and Innovative Team of Heilongjiang Province Universities.
Funding Information:
This study, participants' travel and their attendance to the meeting was funded from the National Clinical Trial Base in Traditional Chinese Medicine, National Key Discipline/Specialty, and the Longjiang Scholars Program and Innovative Team of Heilongjiang Province Universities.
Funding Information:
Dr. Wu has received research funding from the National Clinical Trial Base in Traditional Chinese Medicine (TCM), National Key Discipline/Specialty, and the Longjiang Scholars Program and Innovative Team of Heilongjiang Province Universities. Dr. Legro has received funding from the National Institutes of Health (NIH), the Longjiang Scholars Program, and the 1000-Plan Scholars Program of the Chinese Government, has served as a chair of the Steering Committee for the National Clinical Trial Base in TCM, a consultant to the NIH, Food and Drug Administration, Ferring Pharmaceuticals, Astra Zeneca, and Euroscreen, is a member of the Board of Directors of the American Society of Reproductive Medicine (ASRM), is an Associate Editor of Fertility and Sterility and Seminars in Reproductive Medicine, and is on the editorial boards of Endocrinology and Endocrine Reviews. Dr. Niederberger is Co-Editor-in-Chief of Fertility and Sterility, Section Editor of Journal of Urology, and co-founder and Chief Technology Officer of Nexhand. Dr. Ng has received research funding from Bayer Healthcare, Ferring, Merck Serono, and MSD. Prof. Palomba is Co-Editor-in-Chief of Journal of Ovarian Research, Editor-in-Chief of Current Drug Therapy, and Associate Editor of Human Reproduction. Dr. Zhang has received funding from the NIH, the 1000-Plan Scholars Program of the Chinese Government, and served as a consultant to the Heilongjiang University of Chinese Medicine. Dr. Rebar serves as a Contributing Editor to NEJM Journal Watch Women's Health and has served on several Data Safety Monitoring Committees. Dr. Pellicer is Co-Editor-in-Chief of Fertility and Sterility and reports ownership/stock of Biomedical Supply (Dibimed), Unisense Fertilitech, and Iviomics. Dr. Reindollar is Executive Director of the ASRM and a recipient of NIH funding. Prof. Fauser has received fees and grant support from Actavis, Andromed, Ardana, COGI, Euroscreen, Finox Biotech, Ferring, GenOvum, Gedeon-Richter, Merck Serono, MSD, Organon, OvaScience, Pantharei Bioscience, Preglem, Roche, Schering, Schering Plough, Serono, Uteron, Watson Laboratories, and Wyeth. Prof. Tapanainen has received funding from the Academy of Finland and the Sigrid Juselius Foundation and is chairman of the European Society for Human Reproduction and Embryology (ESHRE) and chairman of the Publication Subcommittee of ESHRE. Dr. Barnhart has received funding from NIH, has served as a consultant to Bayer, Pfizer, and Swiss Precision Diagnostics, is an Associate Editor for Fertility and Sterility, and is a member of the Board of Directors of the ASRM. Dr. Evers is Editor-in-Chief of Human Reproduction. Dr. Silver has received research funding from NIH. Prof. Mol has received fees for lecturing and consultancy from Ferring Pharmaceuticals, MSD, and Besins Healthcare. Prof. Norman has received travel support from Merck Serono and Merck Sharp and Dohme. Prof. Farquhar, Prof. Shankaran, and Dr. van der Poel have nothing to disclose.
Funding Information:
Funding: This study, participants' travel and their attendance to the meeting was funded from the National Clinical Trial Base in Traditional Chinese Medicine, National Key Discipline/Specialty, and the Longjiang Scholars Program and Innovative Team of Heilongjiang Province Universities.
Funding Information:
Conflicts of interest: Dr. Wu has received research funding from the National Clinical Trial Base in Traditional Chinese Medicine (TCM), National Key Discipline/Specialty, and the Longjiang Scholars Program and Innovative Team of Heilongjiang Province Universities. Dr. Legro has received funding from the National Institutes of Health (NIH), the Longjiang Scholars Program, and the 1000-Plan Scholars Program of the Chinese Government, has served as a chair of the Steering Committee for the National Clinical Trial Base in TCM, a consultant to the NIH, Food and Drug Administration, Ferring Pharmaceuticals, Astra Zeneca, and Euroscreen, is a member of the Board of Directors of the American Society of Reproductive Medicine (ASRM), is an Associate Editor of Fertility and Sterility and Seminars in Reproductive Medicine, and is on the editorial boards of Endocrinology and Endocrine Reviews. Dr. Niederberger is Co-Editor-in-Chief of Fertility and Sterility, Section Editor of Journal of Urology, and co-founder and Chief Technology Officer of Nexhand. Dr. Ng has received research funding from Bayer Healthcare, Ferring, Merck Serono, and MSD. Prof. Palomba is Co-Editor-in-Chief of Journal of Ovarian Research, Editor-in-Chief of Current Drug Therapy, and Associate Editor of Human Reproduction. Dr. Zhang has received funding from the NIH, the 1000-Plan Scholars Program of the Chinese Government, and served as a consultant to the Heilongjiang University of Chinese Medicine. Dr. Rebar serves as a Contributing Editor to Journal Watch Women's Health and has served on several Data Safety Monitoring Committees. Dr. Pellicer is Co-Editor-in-Chief of Fertility and Sterility and reports ownership/stock of Biomedical Supply (Dibimed), Unisense Fertilitech, and Iviomics. Dr. Reindollar is Executive Director of the ASRM and a recipient of NIH funding. Prof. Fauser has received fees and grant support from Actavis, Andromed, Ardana, COGI, Euroscreen, Finox Biotech, Ferring, GenOvum, Gedeon-Richter, Merck Serono, MSD, Organon, OvaScience, Pantharei Bioscience, Preglem, Roche, Schering, Schering Plough, Serono, Uteron, Watson Laboratories, and Wyeth. Prof. Tapanainen has received funding from the Academy of Finland and the Sigrid Juselius Foundation and is chairman of the European Society for Human Reproduction and Embryology (ESHRE) and chairman of the Publication Subcommittee of ESHRE. Dr. Barnhart has received funding from NIH, has served as a consultant to Bayer, Pfizer, and Swiss Precision Diagnostics, is an Associate Editor for Fertility and Sterility, and is a member of the Board of Directors of the ASRM. Dr. Evers is Editor-in-Chief of Human Reproduction. Dr. Silver has received research funding from NIH. Prof. Mol has received fees for lecturing and consultancy from Ferring Pharmaceuticals, MSD, and Besins Healthcare. Prof. Norman has received travel support from Merck Serono and Merck Sharp and Dohme. Prof. Farquhar, Prof. Shankaran, and Dr. van der Poel have nothing to disclose.
PY - 2014
Y1 - 2014
N2 - 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), whois also the desired outcome oftreatment. The primary outcome of interestand many adverse events occur after cessationofinfertility 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 inconsistenciesin trial reporting and the unique aspects of infertility trials not adequately addressed byexisting Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modificationsto 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 shouldbe collected and reportedonboth male and female participants in the trial.We propose totrack 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.
AB - 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), whois also the desired outcome oftreatment. The primary outcome of interestand many adverse events occur after cessationofinfertility 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 inconsistenciesin trial reporting and the unique aspects of infertility trials not adequately addressed byexisting Consolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modificationsto 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 shouldbe collected and reportedonboth male and female participants in the trial.We propose totrack 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.
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U2 - 10.1093/humrep/deu218
DO - 10.1093/humrep/deu218
M3 - Article
C2 - 25217611
AN - SCOPUS:84965090539
VL - 29
SP - 2075
EP - 2082
JO - Human Reproduction
JF - Human Reproduction
SN - 0268-1161
IS - 10
ER -