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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01019785
First received: November 23, 2009
Last updated: NA
Last verified: November 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Pregnancy Complication
Dietary Supplement: Ergocalciferol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate [ Time Frame: 4 weeks to 9 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy complications (pregnancy hypertension, SGA, diabetes) [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: November 2009
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High dose Vitamin D Dietary Supplement: Ergocalciferol
100 000 U drops is given once
Other Name: Made by the Swedish APOTEKET
Sham Comparator: Low dose Vitamin D Dietary Supplement: Ergocalciferol
500 U drops given once

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All women initiating IVF treatment

Exclusion Criteria:

  • Women that have entered the study before
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019785

Locations
Sweden
IVF Unit Karolinska University Hospital, Huddinge
Huddinge, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
  More Information

Publications:
Responsible Party: Pelle G Lindqvist, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01019785     History of Changes
Other Study ID Numbers: Delivery2009
Study First Received: November 23, 2009
Last Updated: November 23, 2009
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska University Hospital:
Pregnancy rate (pos test, live fetus at 12 weeks, baby home)
Pregnancy complication (Pregnancy hypertension, SGA, diab)
Thrombin generation

Additional relevant MeSH terms:
Pregnancy Complications
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 15, 2014