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

Phase 3

• Conditions: Pregnancy Complication
• Interventions: Dietary Supplement: Ergocalciferol

• Registration Number: NCT01019785
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-11
• Study Start: 2009-11
• Study First Submitted: 2009-11-23
• Study First Submitted QC: 2009-11-23
• Last Update Submitted: 2009-11-23
• Study First Posted: 2009-11-25
• Last Update Posted: 2009-11-25
• Primary Completion: 2011-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• All women initiating IVF treatment

Exclusion Criteria

• Women that have entered the study before

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose Vitamin D	Ergocalciferol	-
Low dose Vitamin D	Ergocalciferol	-

Primary Outcome Measures

Name	Time	Method
Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate	4 weeks to 9 month

Secondary Outcome Measures

Name	Time	Method
Pregnancy complications (pregnancy hypertension, SGA, diabetes)	9 months

Trial Locations

Locations (1)

IVF Unit Karolinska University Hospital, Huddinge; 🇸🇪 Huddinge, Sweden