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

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ClinicalTrials.gov Identifier: NCT01019785
Recruitment Status : Unknown
Verified November 2009 by Karolinska University Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : November 25, 2009
Last Update Posted : November 25, 2009
Sponsor:
Information provided by:
Karolinska University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Pregnancy Complication Dietary Supplement: Ergocalciferol Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : November 2009
Estimated Primary Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate [ Time Frame: 4 weeks to 9 month ]

Secondary Outcome Measures :
  1. Pregnancy complications (pregnancy hypertension, SGA, diabetes) [ Time Frame: 9 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019785


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

Publications:
Responsible Party: Pelle G Lindqvist, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01019785     History of Changes
Other Study ID Numbers: Delivery2009
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009

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
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents