Effect of Vitamin D Supplementation on In-vitro Fertilization (IVF) Outcomes

Terminated

• Conditions: Vitamin D Deficiency; Infertility

• Registration Number: NCT01419743
• Lead Sponsor: Northwestern University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-16
• Study First Submitted QC: 2011-08-17
• Study First Posted: 2011-08-18
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-16
• Last Update Posted: 2014-02-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 102

Inclusion Criteria

• Infertile women aged ≤ 38 years undergoing fresh invitro fertilization cycles

Read More

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)

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	assessed at conclusion of the study (~ 1 yr)	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.

Trial Locations

Locations (3)

Northwestern Memorial Faculty Foundation; 🇺🇸 Chicago, Illinois, United States

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States