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Effect of Vitamin D Supplementation on In-vitro Fertilization (IVF) Outcomes
This study is currently recruiting participants.
Verified July 2012 by Northwestern University
Study NCT01419743   Information provided by Northwestern University

First Received on August 16, 2011.   Last Updated on July 9, 2012   History of Changes

August 16, 2011
July 9, 2012
August 2011
 
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.
Same as current
Complete list of historical versions of study NCT01419743 on ClinicalTrials.gov Archive Site
 
 
 
 
 
Effect of Vitamin D Supplementation on In-vitro Fertilization (IVF) Outcomes
Randomized Controlled Trial: The Effects of Vitamin D Supplementation on In-vitro Fertilization Outcomes

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
 
Non-Probability Sample

Infertile women aged ≤ 38 years undergoing fresh in-vitro fertilization cycles

  • Infertility
  • Vitamin D Deficiency
 
  • patients with Vit D level of < 20ng/mL: Group 1
    randomized to receive 400 IU of vitamin D per day
  • patients with Vit D levels <20ng/mL: Group 2
    Randomized to receive 2000IU of Vitamin D per day
  • patients with vit D levels between 20-30 ng/mL: Group 3
    Randomized to receiving placebo
  • patients with vit D levels between 20-30 ng/mL: Group 4
    Randomized to receive 400IU of vitamin D per day
  • patients with vit D levels between 20-30 ng/mL: Group 5
    Randomized to receive 2000IU of vitamin D per day
  • patients with vit D levels > 30ng/mL: Group 6
    No treatment

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
 
 

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)
Female
18 Years to 38 Years
No
Contact: Jennifer Eaton, MD Jennifer-Eaton@fsm.northwestern.edu
Contact: Ralph Kazer, MD rkazer@northwestern.edu
United States
 
NCT01419743
Moy 2011 Vit D
No
Irene Moy, Northwestern University
Northwestern University
 
Principal Investigator: Ralph Kazer, MD Northwestern Memorial Faculty Foundation
Study Chair: Irene Moy, MD Northwestern University
Northwestern University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP