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

• Sponsor: Karolinska University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01019785
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Arms: 2

Study Details

Study Description

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; Dietary Supplement: Ergocalciferol	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Study Start Date: Nov 1, 2009
• Anticipated Primary Completion Date: Nov 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: High dose Vitamin D	Dietary Supplement: Ergocalciferol; 100 000 U drops is given once; Other Names: Made by the Swedish APOTEKET
Sham Comparator: Low dose Vitamin D	Dietary Supplement: Ergocalciferol; 500 U drops given once

Outcome Measures

Primary Outcome Measures

1. Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate [4 weeks to 9 month]

Secondary Outcome Measures

1. Pregnancy complications (pregnancy hypertension, SGA, diabetes) [9 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All women initiating IVF treatment

Exclusion Criteria:

• Women that have entered the study before

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IVF Unit Karolinska University Hospital, Huddinge	Huddinge		Sweden	14186

Sponsors and Collaborators

• Karolinska University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

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. doi: 10.1038/sj.bjc.6605149. 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. doi: 10.1111/j.1538-7836.2009.03312.x.

• ClinicalTrials.gov Identifier: NCT01019785
• Other Study ID Numbers: Delivery2009
• First Posted: Nov 25, 2009
• Last Update Posted: Nov 25, 2009
• Last Verified: Nov 1, 2009

• Keywords provided by , ,: 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

Study Results

No Results Posted as of Nov 25, 2009