An observational study in Infertility and Vitamin D Deficiency, sponsored by Northwestern University. Terminated at 3 sites in United States. Open to female participants aged 18 Years to 38 Years. Per ClinicalTrials.gov, last updated 2014-02-19.
Sponsored by Northwestern University · Observational
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.
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 102 is below the median of 200 across 714 observational studies indexed under Infertility.
Browse Infertility studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Infertile women aged ≤ 38 years undergoing fresh in-vitro fertilization cycles
Exclusion Criteria:
randomized to receive 400 IU of vitamin D per day
Randomized to receive 2000IU of Vitamin D per day
Randomized to receiving placebo
Randomized to receive 400IU of vitamin D per day
Randomized to receive 2000IU of vitamin D per day
No treatment
Clinical pregnancy rate
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.
Time frame: assessed at conclusion of the study (~ 1 yr)
This study is terminated, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Northwestern University