View Clinical Trial (Medical Research Study)
Randomized Controlled Trial: The Effects of Vitamin D Supplementation on In-vitro Fertilization Outcomes
| City: |
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Chicago |
| State: |
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Illinois |
| Zip Code: |
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60611 |
| Conditions: |
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Infertility - Vitamin D Deficiency |
| Purpose: |
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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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| Study Summary: |
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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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| Criteria: |
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Inclusion Criteria:
- Infertile women aged ≤ 38 years undergoing fresh invitro fertilization cycles
Exclusion Criteria:
- Infertile women aged > 38 undergoing fresh invitro fertilization cycles
- Patients undergoing frozen embryo transfers
- Patients undergoing donor-egg cycles
- Patients who have a contraindication to receiving Vitamin D (e.g. patients with
history of primary hyperparathyroidism, sarcoidosis, tuberculosis, kidney disease, or
lymphoma)
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| NCT ID: |
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NCT01419743 |
| Primary Contact: |
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Principal Investigator
Ralph Kazer, MD
Northwestern Memorial Faculty Foundation
Jennifer Eaton, MD
Email: Jennifer-Eaton@fsm.northwestern.edu
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| Backup Contact: |
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Email: rkazer@northwestern.edu
Ralph Kazer, MD
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| Location Contact: |
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Chicago, Illinois 60611
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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