The cover letter should state that the material contained in the manuscript has not been published, has not been submitted, or is not being submitted elsewhere for publication. Each author's role in the manuscript should be detailed, and any other persons who contributed to the manuscript (providing writing assistance, for example) should be disclosed. Please note in the cover letter any manuscripts that have been published, submitted, or are in press that are similar to the submission to Fertility and Sterility and include in your submission copies of these so that the editors can be assured that there is no overlap. All authors' agreement to submission of the manuscript should be noted.
Author names and affiliations: Please include each author's full name and highest earned academic degree(s). Where the family name may be ambiguous (e.g., a double name), please indicate this clearly. Present the authors' affiliations below the names. Include the department (if applicable), institution name, city, and state/country. Indicate all affiliations with a lower-case superscript letter immediately after the author's name and in front of the appropriate affiliation. If an author's affiliation has changed since the work was done, the new affiliation also should be listed.
Corresponding author: Only one corresponding author may be designated. Clearly indicate who will handle correspondence at all stages of refereeing and publication, also post-publication. Ensure that phone numbers (with country and area code) are provided in addition to the e-mail address and the complete postal address. Contact details must be kept up to date by the corresponding author.
Disclosure Statement: In the interest of transparency, we ask you to disclose all relationships/activities/interests that are related to the content of your manuscript. "Related" means any relation with for-profit or not-for-profit third parties whose interests may be affected by the content of the manuscript. Disclosure represents a commitment to transparency and does not necessarily indicate a bias. If you are in doubt about whether to list a relationship/activity/interest, it is preferable that you do so.
The author's relationships/activities/interests should be defined broadly. For example, if your manuscript pertains to stimulation for ART, you should declare all relationships with manufacturers of such medication, even if that medication is not mentioned in the manuscript. All authors must disclose any financial and personal relationships with other people or organizations that could influence the design, conductor or reporting of their work. Report all support for the work reported in this manuscript without time limit. For all other items, the time frame for disclosure is the past 36 months. Examples of potential conflicts of interest include employment, consultancies, stock ownership, honoraria, paid expert testimony, patent applications/registrations, and grants or other funding. If there are no competing interests, then please state this for each author: Disclosure: "none'.
All authors are required to report potential conflicts of interest on the title page of the manuscript. The Conflict of Interest form can be found at: ICMJE | Disclosure of Interest. The full form for all authors is required at revision and not submission.
CRediT Authorship Contribution Statement: List each author and their role in the paper choosing from the following options: Conceptualization, Data curation, Formal analysis, Funding acquisition, Investigation, Methodology, Project administration, Resources, Software, Supervision, Validation, Visualization, Writing – original draft, Writing – review & editing
Authors need to identify what will be will be made available to others (i.e. the raw data, individual patient data, a data dictionary that defines each field in the data set, and supporting documentation such as statistical/analytic code). If data will be shared, information on when, where, and how the data will be available (eg, a link to a data repository) and if there will be any restrictions on the use of the data. Authors also have the option to explain why data may not be shared. For more information and examples of data sharing statements, please see the ICMJE data sharing guidelines.
A structured abstract, by means of appropriate headings, should provide the context or background for the research and should state its purpose, basic procedures (selection of study subjects or laboratory animals, observational and analytical methods), main findings (giving specific effect sizes and their statistical significance, if possible), and principal conclusions. It should emphasize new and important aspects of the study or observations. The target word limit for the abstract is 350 words. Do not include abbreviations, acronyms or commercial names in the abstract.
The structured abstract for all study types except systematic reviews should include the sections: Objective (beginning with a phrase like "To study..."), Design, Subjects, Intervention (for RCT) or Exposure (for observational studies), Main Outcome Measures, Results, and Conclusion.
Immediately after the abstract, provide 3–5 keywords, using American spelling and avoiding general and plural terms and multiple concepts (avoid, for example, 'and', 'of'). Be sparing with abbreviations: only abbreviations firmly established in the field may be eligible. These keywords will be used for indexing purposes.
The word limit for the text is 3,500 words. Authors are strongly encouraged to limit article length to 3,500 words for effective and efficient communication. Article length does not include the running title, cover page, capsule, abstract, or references. Only standard medical acronyms should be used and defined with the first use. Authors who feel their English language manuscript may require editing to eliminate possible grammatical or spelling errors and to conform to correct scientific English may wish to use the English Language Editing service available from Elsevier's Author Services.
A clinical trial is a research project that prospectively and randomly assigns human participants to intervention or comparison groups to study the cause-and-effect relationship between an intervention and a health outcome. Interventions include but are not limited to drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes. Trials must be prospectively registered, prior to patient enrollment, in a publicly accessible database such as clinicaltrials.gov.
Required elements to be reported in the manuscript include: The primary hypothesis of the trial must be clearly stated. All outcomes should be clearly specified as primary, secondary or exploratory. Primary outcome must be reported in the abstract. Deviation or amendments from the protocol or original statistical plan should be listed. Target samples size (with underlying assumptions) and final sample should be reported. Inclusion and exclusion criteria should be clearly stated. The essential features of the intervention, blinding (if applicable) and allocation of subject should be clearly delineated. Dates of trial activation, first and last subject enrolled and database lock should be reported in the manuscript. Data for all specified outcomes should be listed, preferably as absolute numbers as well as relative difference (with 95% confidence intervals). The number needed to treat/harm should be presented (when applicable). Post Hoc analysis much be labeled as such. Unexpected and expected adverse events need to be reported. The discussion section should place the results in c ontext with the published literature and address study limitations.
Authors of manuscripts reporting clinical trials must submit trial protocols (including the complete statistical analysis plan) along with their manuscripts. Protocols in non-English languages should be translated into English. The protocol may be redacted of proprietary information, but must include information on the patient flow, statistical plan, samples size and outcomes. Journal editors may ask for more information on redacted protocols.
Cohort and case control studies are observational research when subjects are characterized by a specific exposure and outcome without randomization. The study design, if prospective or retrospective, should be clearly stated along with the a priori hypothesis. A cohort study compares exposed to non-exposed participants to evaluate a specific outcome. A case-control study selects participants based on the outcome (for example pregnant versus non-pregnant participants) and then looks back at exposure, such as a treatment or a risk factor. Each study should include specified detail about the population studied including clear inclusion and exclusion criteria (including the study setting and dates). The exposure and outcome must be clearly defined. If there are multiple exposures or outcomes each must be clearly identified and primary, secondary or exploratory. The data source should be clearly described and data validation methods explicitly stated. Confounding variables available (and pertinent variables not available), should be described. The rationale for the sample size or the power of the study should be stated (even if the study is a sample of convenience). The amount of missing data and how it was managed in the analysis should be stated. Results should be presented clearly and include both crude and adjusted associations with 95% confidence intervals. Statistical methods should be concisely and clearly reported. Causal language should not be used in describing results. The discussion section should place the results in context with the published literature and address study limitations.
Each manuscript should clearly state an objective or hypothesis. The design and methods should be clearly stated. Important information (as applicable to each study type) should include the study setting and dates, patients or participants with inclusion and exclusion criteria, participation or response rates, or data sources (and how the data was validated) should be clearly presented. The essential features of any interventions or exposures and the main outcome (including those a priori noted as primary, secondary or exploratory) must be clearly described. Statistical methods should be concisely and clearly presented. The main results of the study should include crude and adjusted analyses (as applicable). The discussion section should place the results in context with the published literature and address study limitations. Data included in research reports must be original and should be as timely and current as possible.
The EQUATOR Reporting Guidelines should be followed including: STARD for a report of diagnostic test, CHEERS for reports of cost-effective analysis and decision analysis, STREGA for a genetic association study, CHEERS for reporting economic evaluation of health intervention, SQUIRE for reporting on quality improvement in health care.
A meta-analysis is a systematic, critical assessment of literature and data sources pertaining to clinical topics that includes a statistical technique for quantitatively combining the results of multiple studies that measure the same outcome into a single pooled or summary estimate. In absence of statistical pooling, such a systematic assessment of the literature is called a systematic review (see below). We encourage these studies to be prospectively registered (prior to literature search) on a publicly accessible database such as PROSPERO.
Eliran Mor MDAll articles or data sources searched, and selected systematically for inclusion and critically evaluated, and the search and selection process should be described in the manuscript. The specific type of study or analysis, population, intervention, exposure, and tests or outcomes should be described for each article or data source. The data sources should be as current as possible, ideally with the search having been conducted within several months of manuscript submission. Meta-analyses of observation studies should include adjustment for pertinent confounding variables. Heterogeneity, publication bias, as well as quality and trustworthiness of evidence from the source studies should be assessed and reported.
As it is becoming more and more apparent that a substantial part of the medical literature, including randomized clinical trials, is not trustworthy, Fertility and Sterility now has the policy that published and unpublished randomized clinical trials that are included in meta-analysis should be assessed for their quality.
The EQUATOR Reporting Guidelines should be followed. Authors of reports of meta-analyses of clinical trials should submit the PRISMA flow diagram and checklist. Authors of meta-analyses of observational studies should submit the MOOSE checklist. Checklists are not required but attestations that checklists were followed should be listed in the title page.
A systematic review (without meta-analysis) is a critical assessment of the literature and data sources pertaining to clinical topics. Systematic Reviews should address a specific question or issue that is relevant for clinical practice and provide an evidence-based, balanced, patient-oriented review on a focused topic.
A research letter is a concise, focused report of original research. A research letter can include any of the study types listed under Original Investigation and is not a review, case report, or editorial content. Original research may include sub-analyses or updates of previously published research, pilot studies or pre-clinical research but must not duplicate other material published or submitted for publication. A research letter is considered a scientific publication; authors must meet all requirements regarding responsible conduct of research (e.g. appropriate IRB approval, data integrity, data retention) and the policies outlined in the journal's Instructions for Authors likewise apply.
A laboratory based study provides original data from research performed in vitro or in vivo that address questions not amenable to the study of human subjects. Such studies can involve database analysis, bench, or other laboratory techniques, but the methods required must be sufficiently detailed to allow for replication of experiments in other laboratories. The hypothesis or objective must be clear and concise, with experiments providing data that supports or refutes the central hypothesis. Statistical methods should be concisely and clearly presented. The discussion section should place the results in context with the published literature, identify controversies, address implications, and identify areas for future advancement.
A Letter to the Editor and Reply must include a title page, conflict of interest disclosure, and a Statement of Authorship signed by all authors. These submissions are subject to minor editorial alterations, may be shortened without the authors' approval, and are published both in print and on the Journal website.
Selected Letters to the Editors that focus on at least 1 article published in Fertility and Sterility within the previous 12 issues are considered for publication. Letters to the Editors are limited to 3 authors, 400 words (not counting the title page or references), and 1 to 4 references. At least one of the references must cite the related Journal article(s). All data presented must be fully citable and cited in the supporting reference list (unpublished data must not be described in the letter).
The editors routinely invite the author(s) of the related article to respond in writing. Letters that include specific questions for the original article's authors are prioritized for publication. Published letters are accompanied by either a reply from the original authors or the statement "Reply declined."
Video submissions are peer reviewed, citable and indexed as publications in PubMed. The video article format allows you to provide a video demonstration of both the data and technique of your study. The following categories are taken into consideration during the review process: educational/scientific merit and clinical relevance of the topic; clarity of video; use of innovative surgical technique; and video editing or use of marking tools on the video to highlight important features or surgical landmarks.
Video articles should provide a significant contribution to the medical literature. They should include original data or provide a review of a subject. The visual demonstration of the topic is a key component and the video should demonstrate information beyond what would be in text alone. Videos should NOT be a series of text-only slides.
Videos should have an audio narration track. Silent videos will not be likely to be accepted. Music should be used with careful consideration. When utilized creatively, music can enhance some videos. If music is used, the author must obtain permission from the copyright holder or documentation that the music is royalty- free. The start of the video should include the title of the video and the author's name and institution. Commercial-type messages should not be used.
Aspect ratio: We prefer videos to be in 16:9 format because we use 16:9 aspect ratio players. If you are uploading a non-16:9 file, it will be processed and displayed correctly as well, with pillar boxes or letter boxes provided by the player. If you want to fit the player perfectly, encode at these resolutions: 1080p: 19201080, 720p: 1280720
Any patient identification must be removed or masked.Include the following statement of consent in both the written abstract and the video (include within the first 30 seconds). The patient(s) included in this video gave consent for publication of the video and posting of the video online including social media, the journal website, scientific literature websites (such as PubMed, ScienceDirect, Scopus, etc.) and other applicable sites.
Consider This pieces are published on the main Fertility and Sterility website and have subcategories as follows: •Consider the Ethics: an opportunity for you to dissect the ethical implications of an idea, product, or approach •Consider the Moment: an opportunity for you to reflect on how a current event impacts the field of reproductive medicine •Consider this Idea: an opportunity for you to generate a novel hypothesis or propose a novel approach to an old problem •Consider this Paper: an opportunity to reflect on a paper published either in the Fertility and Sterility family of journals or other journals All submissions go through a peer review process and are citable via a DOI and unique URL. They are not indexed on PubMed but are archived on Google Scholar.
Submissions should be no more than 2,000 words and have a maximum of 5 references. They can be submitted via Editorial Manager with the article type Consider This. All pieces must include a cover image that will be displayed along with the submission on the Fertility and Sterility webpage.
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