The Impact of Lifestyle Behavior on in Vitro Fertilization (IVF) Outcome
| Tracking Information | |||||
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| First Received Date ICMJE | July 27, 2011 | ||||
| Last Updated Date | January 11, 2012 | ||||
| Start Date ICMJE | September 2011 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Clinical Pregnancy Rates [ Time Frame: Approximately 28 days (1 IVF cycle) ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01404858 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Impact of Lifestyle Behavior on in Vitro Fertilization (IVF) Outcome | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | The purpose of this study is to prospectively examine the impact of various lifestyle habits in both men and women on the outcome of in vitro fertilization. There are 25 infertility centers in the United States which use the electronic medical record collection entity eIVF, made by Practice Highway, to collect medical and demographic information on the patients who are undergoing treatment at these centers. Information on every aspect of each cycle is also electronically collected daily during each cycle. Demographic and lifestyle information will be collected on all patients prior to cycle start and lifestyle habit information will be collected each time a patient logs onto the patient portal, which averages every few days. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Men and women undergoing IVF at a infertility clinic who uses eIVF, an electronic medical record collection entity specifically for IVF patients |
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| Condition ICMJE | Infertility | ||||
| Intervention ICMJE | Behavioral: There is no intervention; this is a survey only study
There is no intervention; this is a survey only study |
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| Study Group/Cohort (s) | Patients undergoing IVF
Intervention: Behavioral: There is no intervention; this is a survey only study |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 2500 | ||||
| Estimated Completion Date | September 2013 | ||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Eligible patients include, any patient whose:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01404858 | ||||
| Other Study ID Numbers ICMJE | DC2011 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Alice D. Domar, PhD, Boston IVF | ||||
| Study Sponsor ICMJE | Boston IVF | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Boston IVF | ||||
| Verification Date | January 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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