Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT)

Modifying the CONSORT statement

Harbin Consensus Conference Workshop Group

Research output: Contribution to journalArticle

33 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 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 creates 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 after ≥20 weeks' gestation) 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 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.

Original languageEnglish (US)
Pages (from-to)952-959.e15
JournalFertility and sterility
Volume102
Issue number4
DOIs
StatePublished - Oct 1 2014

Fingerprint

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

All Science Journal Classification (ASJC) codes

  • Obstetrics and Gynecology
  • Reproductive Medicine
  • Medicine(all)

Cite this

Harbin Consensus Conference Workshop Group. / Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT) : Modifying the CONSORT statement. In: Fertility and sterility. 2014 ; Vol. 102, No. 4. pp. 952-959.e15.
@article{ab802c40a1064302926c2365b551664d,
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 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 creates 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 after ≥20 weeks' gestation) 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 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.",
author = "{Harbin Consensus Conference Workshop Group} and Richard Legro and Xiaoke Wu",
year = "2014",
month = "10",
day = "1",
doi = "10.1016/j.fertnstert.2014.08.002",
language = "English (US)",
volume = "102",
pages = "952--959.e15",
journal = "Fertility and Sterility",
issn = "0015-0282",
publisher = "Elsevier Inc.",
number = "4",

}

Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT) : Modifying the CONSORT statement. / Harbin Consensus Conference Workshop Group.

In: Fertility and sterility, Vol. 102, No. 4, 01.10.2014, p. 952-959.e15.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Improving the Reporting of Clinical Trials of Infertility Treatments (IMPRINT)

T2 - Modifying the CONSORT statement

AU - Harbin Consensus Conference Workshop Group

AU - Legro, Richard

AU - Wu, Xiaoke

PY - 2014/10/1

Y1 - 2014/10/1

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 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 creates 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 after ≥20 weeks' gestation) 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 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.

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 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 creates 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 after ≥20 weeks' gestation) 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 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.

UR - http://www.scopus.com/inward/record.url?scp=84908212105&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84908212105&partnerID=8YFLogxK

U2 - 10.1016/j.fertnstert.2014.08.002

DO - 10.1016/j.fertnstert.2014.08.002

M3 - Article

VL - 102

SP - 952-959.e15

JO - Fertility and Sterility

JF - Fertility and Sterility

SN - 0015-0282

IS - 4

ER -