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Tracking Information | |||||||||
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First Received Date ICMJE | August 16, 2011 | ||||||||
Last Updated Date | July 9, 2012 | ||||||||
Start Date ICMJE | August 2011 | ||||||||
Primary Completion Date | |||||||||
Current Primary Outcome Measures ICMJE |
Clinical pregnancy rate [ Time Frame: assessed at conclusion of the study (~ 1 yr) ] [ Designated as safety issue: No ] Serum hCG will be drawn per routine IVF protocol (~ 10 days after embryo transfer). Patients will have a repeat bHCG drawn 48hrs if they have a positive result from the first bHCG test. Clinical pregnancy will be defined as ultrasound documentation of fetal heart tones. |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01419743 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE | |||||||||
Original Secondary Outcome Measures ICMJE | |||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Effect of Vitamin D Supplementation on In-vitro Fertilization (IVF) Outcomes | ||||||||
Official Title ICMJE | Randomized Controlled Trial: The Effects of Vitamin D Supplementation on In-vitro Fertilization Outcomes | ||||||||
Brief Summary | Historically, vitamin D has been considered to play a role solely in bone and calcium metabolism. Numerous studies have suggested a link between vitamin D deficiency and adverse health outcomes such as malignancy, cardiovascular disease, immune functioning, and glucose metabolism. In the obstetrics literature, vitamin D deficiency has been linked to preeclampsia, gestational diabetes, and increased rate of cesarean section rate. Recent data from retrospective chart reviews have demonstrated a possible role of vitamin D in implantation and clinical pregnancy rates in patients undergoing in-vitro fertilization. Patients found to be deficient in vitamin D were found to have significantly lower clinical pregnancy rates when compared to patients who were replete in vitamin D levels. Currently, there are no prospective clinical trials investigating the effects of vitamin D supplementation on IVF outcomes such as clinical pregnancy rate and implantation rates. The investigators hypothesize that the vitamin D supplementation in patients found to be either deficient or insufficient in vitamin D will lead to improved pregnancy rates in infertility patients undergoing in-vitro fertilization. |
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Detailed Description | The trial will not pay for or subsidize for IVF treatment. Participants will receive blood Vitamin D screening test and any necessary supplements free of charge. |
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Study Type ICMJE | Observational | ||||||||
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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Biospecimen | |||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | Infertile women aged ≤ 38 years undergoing fresh in-vitro fertilization cycles |
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Condition ICMJE |
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Intervention ICMJE | |||||||||
Comparison Groups |
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Publications * |
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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 | Recruiting | ||||||||
Estimated Enrollment ICMJE | 250 | ||||||||
Completion Date | |||||||||
Primary Completion Date | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||||||
Ages | 18 Years to 38 Years | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01419743 | ||||||||
Other Study ID Numbers ICMJE | Moy 2011 Vit D | ||||||||
Has Data Monitoring Committee | No | ||||||||
Responsible Party | Irene Moy, Northwestern University | ||||||||
Study Sponsor ICMJE | Northwestern University | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
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Information Provided By | Northwestern University | ||||||||
Verification Date | July 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |