Clinical trial NCT01419743: Effect of Vitamin D Supplementation on In-vitro Fertilization (IVF) Outcomes
Official title: Randomized Controlled Trial: The Effects of Vitamin D Supplementation on In-vitro Fertilization Outcomes
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Infertility
Vitamin D Deficiency
Keywords: Vitamin D deficiency
Supplementation
Infertility
Clinical pregnancy rates
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2011-08-18
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile women aged ≤ 38 years undergoing fresh in-vitro fertilization cycles

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.

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 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)

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: assessed at conclusion of the study (~ 1 yr)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Faculty Foundation
state: Illinois
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
Study officials:
affiliation: Northwestern Memorial Faculty Foundation
name: Ralph Kazer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Irene Moy, MD
role: STUDY_CHAIR
References:
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