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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
Sponsor:
Information provided by (Responsible Party):
Irene Moy, Northwestern University
ClinicalTrials.gov Identifier:
NCT01419743
First received: August 16, 2011
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Phase
Infertility
Vitamin D Deficiency
 Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Randomized Controlled Trial: The Effects of Vitamin D Supplementation on In-vitro Fertilization Outcomes

Resource links provided by NLM:

Drug Information available for: Vitamin D
U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 250
Study Start Date: August 2011
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419743

Contacts
Contact: Jennifer Eaton, MD Jennifer-Eaton@fsm.northwestern.edu
Contact: Ralph Kazer, MD rkazer@northwestern.edu

Locations
United States, Illinois
Northwestern Memorial Faculty Foundation Not yet recruiting
Chicago, Illinois, United States, 60611
Sub-Investigator: Irene Moy, MD            
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Ralph Kazer, MD Northwestern Memorial Faculty Foundation
Study Chair: Irene Moy, MD Northwestern University
  More Information

Publications:

Responsible Party: Irene Moy, Clinical Fellow, Northwestern University
ClinicalTrials.gov Identifier: NCT01419743     History of Changes
Other Study ID Numbers: Moy 2011 Vit D
Study First Received: August 16, 2011
Last Updated: July 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Vitamin D deficiency
Supplementation
Infertility
Clinical pregnancy rates

Additional relevant MeSH terms:
Infertility
Vitamin D Deficiency
Genital Diseases, Male
Genital Diseases, Female
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
 Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on June 17, 2013