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:

MedlinePlus related topics: High Blood Pressure Vitamin D

Drug Information available for: Ergocalciferol Vitamin D

U.S. FDA Resources

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:

Epstein E, Lindqvist PG, Geppert B, Olsson H. A population-based cohort study on sun habits and endometrial cancer. Br J Cancer. 2009 Aug 4;101(3):537-40. Epub 2009 Jun 23.

Lindqvist PG, Epstein E, Olsson H. Does an active sun exposure habit lower the risk of venous thrombotic events? A D-lightful hypothesis. J Thromb Haemost. 2009 Apr;7(4):605-10.

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 May 23, 2013

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