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

Pregnancy Complication Clinical Trial

— Delivery  

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01019785
• Other study ID #: Delivery2009
• Status: Enrolling by invitation
• Phase: Phase 3
• First received: November 23, 2009
• Last updated: November 23, 2009
• Start date: November 2009

Study information

• Verified date: November 2009
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1000
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All women initiating IVF treatment

Exclusion Criteria:

• Women that have entered the study before

Study Design

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

Related Conditions & MeSH terms

• Pregnancy Complication
• Pregnancy Complications

Intervention

Dietary Supplement:
• Ergocalciferol
100 000 U drops is given once
• Ergocalciferol
500 U drops given once

Locations

Country	Name	City	State
Sweden	IVF Unit Karolinska University Hospital, Huddinge	Huddinge

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

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. doi: 10.1038/sj.bjc.6605149. Epub 2009 Jun 23. — View Citation

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. doi: 10.1111/j.1538-7836.2009.03312.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate		4 weeks to 9 month	No
Secondary	Pregnancy complications (pregnancy hypertension, SGA, diabetes)		9 months	No