Improving the reporting of Clinical trials of infertility treatments (IMPRINT): Modifying the CONSORT statement

Richard S. Legro, Xiaoke Wu, Kurt T. Barnhart, Cynthia Farquhar, Bart C.J.M. Fauser, Ben Mol

Research output: Contribution to journalArticle

37 Citations (Scopus)

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), 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.

Original languageEnglish (US)
Pages (from-to)2075-2082
Number of pages8
JournalHuman Reproduction
Volume29
Issue number10
DOIs
StatePublished - Jan 1 2014

Fingerprint

Infertility
Clinical Trials
Live Birth
Pregnancy
Therapeutics
Consensus
Mothers
Checklist
Fathers
Postpartum Period
China
Research Personnel
Guidelines

All Science Journal Classification (ASJC) codes

  • Reproductive Medicine
  • Obstetrics and Gynecology

Cite this

Legro, Richard S. ; Wu, Xiaoke ; Barnhart, Kurt T. ; Farquhar, Cynthia ; Fauser, Bart C.J.M. ; Mol, Ben. / Improving the reporting of Clinical trials of infertility treatments (IMPRINT) : Modifying the CONSORT statement. In: Human Reproduction. 2014 ; Vol. 29, No. 10. pp. 2075-2082.
@article{8c44baa2611543fd8777de964e0eadd8,
title = "Improving the reporting of Clinical trials of infertility treatments (IMPRINT): Modifying the CONSORT statement",
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), 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.",
author = "Legro, {Richard S.} and Xiaoke Wu and Barnhart, {Kurt T.} and Cynthia Farquhar and Fauser, {Bart C.J.M.} and Ben Mol",
year = "2014",
month = "1",
day = "1",
doi = "10.1093/humrep/deu218",
language = "English (US)",
volume = "29",
pages = "2075--2082",
journal = "Human Reproduction",
issn = "0268-1161",
publisher = "Oxford University Press",
number = "10",

}

Improving the reporting of Clinical trials of infertility treatments (IMPRINT) : Modifying the CONSORT statement. / Legro, Richard S.; Wu, Xiaoke; Barnhart, Kurt T.; Farquhar, Cynthia; Fauser, Bart C.J.M.; Mol, Ben.

In: Human Reproduction, Vol. 29, No. 10, 01.01.2014, p. 2075-2082.

Research output: Contribution to journalArticle

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

PY - 2014/1/1

Y1 - 2014/1/1

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.

UR - http://www.scopus.com/inward/record.url?scp=84965090539&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84965090539&partnerID=8YFLogxK

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 -