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

Primary Purpose

Pregnancy Complication

Status
Unknown status
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Ergocalciferol
Ergocalciferol
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy Complication focused on measuring Pregnancy rate (pos test, live fetus at 12 weeks, baby home), Pregnancy complication (Pregnancy hypertension, SGA, diab), Thrombin generation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • All women initiating IVF treatment

Exclusion Criteria:

  • Women that have entered the study before

Sites / Locations

  • IVF Unit Karolinska University Hospital, Huddinge

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

High dose Vitamin D

Low dose Vitamin D

Arm Description

Outcomes

Primary Outcome Measures

Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate

Secondary Outcome Measures

Pregnancy complications (pregnancy hypertension, SGA, diabetes)

Full Information

First Posted
November 23, 2009
Last Updated
November 23, 2009
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01019785
Brief Title
Vitamin D During In Vitro Fertilisation (IVF) - A Prospective Randomized Trial
Acronym
Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Karolinska University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complication
Keywords
Pregnancy rate (pos test, live fetus at 12 weeks, baby home), Pregnancy complication (Pregnancy hypertension, SGA, diab), Thrombin generation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High dose Vitamin D
Arm Type
Active Comparator
Arm Title
Low dose Vitamin D
Arm Type
Sham Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Ergocalciferol
Other Intervention Name(s)
Made by the Swedish APOTEKET
Intervention Description
100 000 U drops is given once
Intervention Type
Dietary Supplement
Intervention Name(s)
Ergocalciferol
Intervention Description
500 U drops given once
Primary Outcome Measure Information:
Title
Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate
Time Frame
4 weeks to 9 month
Secondary Outcome Measure Information:
Title
Pregnancy complications (pregnancy hypertension, SGA, diabetes)
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All women initiating IVF treatment Exclusion Criteria: Women that have entered the study before
Facility Information:
Facility Name
IVF Unit Karolinska University Hospital, Huddinge
City
Huddinge
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
19550419
Citation
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.
Results Reference
background
PubMed Identifier
19335448
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.
Results Reference
background
PubMed Identifier
32851663
Citation
Showell MG, Mackenzie-Proctor R, Jordan V, Hart RJ. Antioxidants for female subfertility. Cochrane Database Syst Rev. 2020 Aug 27;8(8):CD007807. doi: 10.1002/14651858.CD007807.pub4.
Results Reference
derived

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

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