Vitamin D During In Vitro Fertilisation (IVF) - A Prospec... | NCT01019785

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

NCT01019785

Sponsor

Karolinska University Hospital

Status

Unknown status

Last Update Posted

Nov 25, 2009Estimated

Enrollment

1,000Estimated

Phase

Phase 3

Conditions

Pregnancy Complication

Interventions

Ergocalciferol
Ergocalciferol

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009

Primary Completion Date

Nov 2011Estimated

Completion Date

Not provided

First Submitted Date

Nov 23, 2009

First Submission Date that Met QC Criteria

Nov 23, 2009

First Posted Date

Nov 25, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 23, 2009

Last Update Posted Date

Nov 25, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High dose Vitamin D	Active Comparator		Dietary Supplement: Ergocalciferol
Low dose Vitamin D	Sham Comparator		Dietary Supplement: Ergocalciferol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ergocalciferol	Dietary Supplement	100 000 U drops is given once	High dose Vitamin D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Laboratory pregnancy, live pregnancy at 12 weeks, take home baby rate		4 weeks to 9 month

Secondary Outcomes

Measure	Description	Time Frame
Pregnancy complications (pregnancy hypertension, SGA, diabetes)		9 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All women initiating IVF treatment

Exclusion Criteria:

Women that have entered the study before

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IVF Unit Karolinska University Hospital, Huddinge		Huddinge		14186	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19550419	Background	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.
19335448	Background	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.

ID	Term
D011248	Pregnancy Complications
D046110	Hypertension, Pregnancy-Induced

ID	Term
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D006973	Hypertension
D014652	Vascular Diseases

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds