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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 19, 2014