Human Reproduction extended abstractclinicalstudy manuscript

Use MESH* terms in title and abstract.

Please complete all sections; please do not remove or change headings.

Title:[if RCT, identify the trial as being randomised in title]

Abstract

Study question: [A SINGLE question (ending in a question mark), limited to the PRIMARY objective of the study ONLY (do not include secondary questions)]

Summary answer: [The main conclusion. A single sentence, this should be limited to the primary results of the study, without any discussion of their implications]

What is known already: [One or two short sentences]

Study design, size, duration: [RCT, cohort study, case control study, cross sectional study, diagnostic test; sample size calculation; total number of subjects involved; time period in which study was performed]

  • If RCT: briefly describe size and duration, intervention(s), blinding, randomization procedure, allocation concealment
  • If cohort study: briefly describe size and duration, prospective/retrospective, (lost to) follow-up, attrition
  • If case control study: briefly describe number of cases and controls, duration, exposures
  • If cross sectional study: briefly describe size
  • If diagnostic test study: briefly describe size and duration, reference standard and comparator/index test, blinding

Participants/materials, setting, methods: [matching criteria (for matched studies), numbers exposed/unexposed, numbers of controls per case, distribution of severity of disease in those with target condition]

Main results and the role of chance:

  • If RCT: include absolute event rates for primary outcome(s) among experimental and control groups, p value(s) and confidence intervals, relative risk reduction, number needed to treat or harm.
  • If cohort study: include absolute event rates over time in exposed and unexposed, relative risk reduction.
  • If case control study: include odds ratio for strength of association between exposure and outcome.
  • If cross sectional study: include response rate
  • If diagnostic test study: include sensitivity, specificity, positive and negative predictive values, likelihood ratios. Number needed to screen (if screening study)

Limitations, reasons for caution: [bias, confounding, power]

Wider implications of the findings: [generalisability to other populations, agreement/disagreement with literature, resolution of previous disparity, new insights]

Study funding/competing interest(s):[an ICMJE Disclosure form must be completed if any competing interest is declared]

Trial registration number: [if the study is an RCT, a trial number from an ICMJE-recognised trial registry (see must be included]

Trial registration date: [if the study is an RCT, the date of registration in an ICMJE-recognised trial registry must be included]

Date of first patient’s enrolment:[if the study is an RCT, the date of enrolment of the first patient into the trial must be included]

* for MESH terms see PubMed at

Version 2.7 02/04/2015