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

NCT ID: NCT01019785

Last Updated: 2009-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Brief Summary

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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

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Conditions

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Pregnancy Complication

Keywords

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Pregnancy rate (pos test, live fetus at 12 weeks, baby home) Pregnancy complication (Pregnancy hypertension, SGA, diab) Thrombin generation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High dose Vitamin D

Group Type ACTIVE_COMPARATOR

Ergocalciferol

Intervention Type DIETARY_SUPPLEMENT

100 000 U drops is given once

Low dose Vitamin D

Group Type SHAM_COMPARATOR

Ergocalciferol

Intervention Type DIETARY_SUPPLEMENT

500 U drops given once

Interventions

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Ergocalciferol

100 000 U drops is given once

Intervention Type DIETARY_SUPPLEMENT

Ergocalciferol

500 U drops given once

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Made by the Swedish APOTEKET

Eligibility Criteria

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Inclusion Criteria

* All women initiating IVF treatment

Exclusion Criteria

* Women that have entered the study before
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karolinska University Hospital

Locations

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IVF Unit Karolinska University Hospital, Huddinge

Huddinge, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 19550419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19335448 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32851663 (View on PubMed)

Other Identifiers

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Delivery2009

Identifier Type: -

Identifier Source: org_study_id