Vitamin D During In Vitro Fertilisation (IVF) - A Prospective Randomized Trial (Delivery)

November 23, 2009 updated by: Karolinska University Hospital
During IVF treatment women will be randomized into supplementation with a high or a low dose of Vitamin D Main outcome Laboratory pregnancy, live pregnancy at 12 weeks, Baby take home rate, OHSS Secondary outcome: 1. Pregnancy complications (pregnancy hypertension, SGA, Diabetes) 2.Thrombin generation

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Huddinge, Sweden, 14186
        • IVF Unit Karolinska University Hospital, Huddinge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All women initiating IVF treatment

Exclusion Criteria:

  • Women that have entered the study before

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High dose Vitamin D
Dietary supplement: Ergocalciferol
100 000 U drops is given once
Other Names:
  • Made by the Swedish APOTEKET
Dietary supplement: Ergocalciferol
500 U drops given once
Sham Comparator: Low dose Vitamin D
Dietary supplement: Ergocalciferol
100 000 U drops is given once
Other Names:
  • Made by the Swedish APOTEKET
Dietary supplement: Ergocalciferol
500 U drops given once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate
Time Frame: 4 weeks to 9 month
4 weeks to 9 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Pregnancy complications (pregnancy hypertension, SGA, diabetes)
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

November 1, 2011

Study Registration Dates

First Submitted

November 23, 2009

First Submitted That Met QC Criteria

November 23, 2009

First Posted (Estimate)

November 25, 2009

Study Record Updates

Last Update Posted (Estimate)

November 25, 2009

Last Update Submitted That Met QC Criteria

November 23, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Delivery2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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