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NCT01419743 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Northwestern University.

Terminated
Registry status
102
Enrollment target

NCT01419743: Clinical Trial study, sponsored by Northwestern University.

NCT01419743 is a clinical trial that was terminated before completion, run by Northwestern University. The registered enrollment target is 102 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01419743 was terminated before completion, sponsored by Northwestern University.

TERMINATED
Registry status
102 participants
Enrollment target

Study 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.

Primary Outcome

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 Details

FieldValue
Enrollment Target 102 participants
Start Date 2011-08
Est. Completion 2014-01
Northwestern University

1,209 total trials

Why NCT01419743 stopped before completion

NCT01419743 is an observational study that tracks outcomes without assigning an intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT01419743 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01419743 about?

NCT01419743 is a clinical study titled "Effect of Vitamin D Supplementation on In-vitro Fertilization (IVF) 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 ...

What is the current status of trial NCT01419743?

This trial is currently terminated. The enrollment target is 102 participants. The study started on 2011-08. Estimated completion is 2014-01.

Who is sponsoring clinical trial NCT01419743?

This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01419743, the US trial registry maintained by the National Library of Medicine. NCT01419743 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.