Cited by 129Meta-analysis and systematic reviewsReproductive Health and TechnologiesStatistical Methods in Clinical Trials

Improving the reporting of clinical trials of infertility treatments (IMPRINT): modifying the CONSORT statement

Open access
The Harbin Consensus Conference Workshop Group, Conference Chairs:, Legro, Richard S., Wu, Xiaoke, Scientific Committee:, Barnhart, Kurt T., Farquhar, Cynthia, Fauser, Bart C.J.M. +38 more·2014·Human Reproduction

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.

Integrity signals

Registry

Crossref · 10.1093/humrep/deu218

Cites

98 of 98 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

The text we found for this paper looks like another document, so its claims and self-check weren’t run. The registry and citation checks still apply.

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

The text we found for this paper looks like another document, so the self-check wasn’t run.

Cites

Flagged first, then by citations

Cited by

Sorted by citations

Authors
The Harbin Consensus Conference Workshop Group, Chairs:, C., Legro, R. S., Wu, X., Scientific Committee:, Barnhart, K. T., Farquhar, C., Fauser, B. C. J. M., Mol, B., Legro, R. S., Wu, X., Barnhart, K., Niederberger, C., Ng, E. H. Y., Palomba, S., Maria, A. S., Emilia, R., Zhang, H., Farquhar, C., Rebar, R. W., Pellicer, A., Reindollar, R., Fauser, B. C. J. M., Tapanainen, J. S., Evers, H., Shankaran, S., Silver, R. M., Mol, B., Norman, R. J., Silver, R. M., Bhattacharya, S., Vanderpoel, S., Bhattacharya, S., Evers, J. L., Ng, E. H. Y., Niederberger, C., Norman, R. J., Palomba, S., Pellicer, A., Reindollar, R., Rebar, R., Shankaran, S., Silver, R. M., Tapanainen, J. S., Vanderpool, S., & Zhang, H.
Affiliations
  • Pennsylvania State University (US)
  • Heilongjiang University of Chinese Medicine (CN)
Venue
Human Reproduction
Published
2014-10-10
Volume
29
Issue
10
Pages
2075-2082
ISSN
  • 0268-1161 (ISSN-L)
  • 1460-2350
OpenAlex
W2137118345
Cited by
129
References
98
Citations by year
2026: 1 · 2025: 7 · 2024: 10 · 2023: 5 · 2022: 7 · 2021: 21 · 2020: 16 · 2019: 10 · 2018: 10 · 2017: 18 · 2016: 14 · 2015: 8 · 2014: 2
FWCI
13.65
Type
journal article
Language
en
Open access
Locations
  • Human Reproduction (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
  • Research Publications (Maastricht University) (publishedVersion, other-oa)
  • The HKU Scholars Hub (University of Hong Kong) (submittedVersion)
  • IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
  • ResearchSpace (University of Auckland) (submittedVersion)
  • Research Publications (Maastricht University) (submittedVersion, other-oa)
Funders
  • Pfizer
  • World Health Organization
  • Yale University (CT 06520)
  • UNICEF
  • Wayne State University
  • University of Pennsylvania
  • Michigan State University
  • Dartmouth College
  • Helsingin ja Uudenmaan Sairaanhoitopiiri
  • Auckland District Health Board
  • University of Aberdeen
  • University of Adelaide
  • Universiteit Maastricht
  • Universitat de València
  • University of Hong Kong
  • Heilongjiang University of Chinese Medicine
  • European Society of Human Reproduction and Embryology
  • National Institutes of Health
  • College of Engineering, Michigan State University
  • Perelman School of Medicine, University of Pennsylvania
  • Audrey and Theodor Geisel School of Medicine at Dartmouth
  • Penn State College of Medicine
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (U10HD038992)
Topics
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Health Sciences › Medicine › Reproductive Medicine › Reproductive Health and Technologies
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Keywords
infertility treatment, clinical trial reporting, CONSORT statement, reporting guidelines, live birth, cumulative live birth, adverse events, pregnancy outcomes, fetal malformations, maternal risk factors, postpartum period, neonatal outcomes, primary outcome definition
MeSH terms
China, Clinical Trials as Topic, Female, Follow-Up Studies, Humans, Infertility, Male, Pregnancy, Pregnancy Outcome, Research Design, Treatment Outcome, Reproductive Techniques, Assisted

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review