NCT02187146

Brief Summary

The purpose of this study is to investigate whether an association exists between serum vitamin D levels and IVF treatment outcome

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
504

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

1.2 years

First QC Date

July 8, 2014

Last Update Submit

October 24, 2016

Conditions

Vitamin D DeficiencyVitamin D InsufficiencyInfertility

Keywords

Vitamin DInfertilityIVFART

Outcome Measures

Primary Outcomes (1)

  • Clinical Pregnancy Rate

    USS appearances of intrauterine pregnancy

    7 weeks after embryo transfer

Secondary Outcomes (3)

  • Biochemical pregnancy rate

    2 weeks after embryo transfer

  • Miscarriage rate

    20 weeks after embryo transfer

  • Live birth rate

    42 weeks after embryo transfer

Study Arms (1)

ART population

Patients undergoing IVF/ICSI/FET treatment at the Birmingham Womens Fertility Centre 2013-2014

Eligibility Criteria

Age23 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients undergoing IVF, ICSI and FET treatment cycles at the Birmingham Womens Fertility Centre

You may qualify if:

  • All patients undergoing IVF, ICSI or FET treatment at Birmingham Womens Fertility Centre

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Birmingham Womens NHS Foundation Trust

Birmingham, West Midlands, B15 2TG, United Kingdom

Location

Related Publications (1)

  • Chu J, Gallos I, Tobias A, Robinson L, Kirkman-Brown J, Dhillon-Smith R, Harb H, Eapen A, Rajkhowa M, Coomarasamy A. Vitamin D and assisted reproductive treatment outcome: a prospective cohort study. Reprod Health. 2019 Jul 15;16(1):106. doi: 10.1186/s12978-019-0769-7.

    PMID: 31307482DERIVED

MeSH Terms

Conditions

Vitamin D DeficiencyInfertility

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesGenital DiseasesUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

July 8, 2014

First Posted

July 10, 2014

Study Start

September 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2015

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations

GB(1)