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Trial registered on ANZCTR


Registration number
ACTRN12619000083190
Ethics application status
Approved
Date submitted
14/01/2019
Date registered
21/01/2019
Date last updated
21/01/2019
Date data sharing statement initially provided
21/01/2019
Date results information initially provided
21/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of vitamin d level on in vitro fertilisation outcomes
Scientific title
The association of vitamin d status with clinical pregnancy and live birth outcomes in women undergoing in vitro fertilisation
Secondary ID [1] 297073 0
nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Infertility 311078 0
Condition category
Condition code
Reproductive Health and Childbirth 309714 309714 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
All fresh embryo transfer treatment cycles initiated from 1st April 2008 to 30th June 2016 will be retrospectively extracted from PIVET Medical Centre’s long-established, validated database. The data including patients vitamin d level was recorded as part of routine clinical practice at PIVET. Approval for analysis and publication of such retrospective data was initially provided by Curtin University Human Research Ethics Committee in 2010, annually renewed since then with the latest annual approval occurring on 20/8/2018.
Intervention code [1] 313348 0
Not applicable
Comparator / control treatment
All fresh embryo transfer treatment cycles initiated from 1st April 2008 to 30th June 2016 at PIVET Medical Centre will be analysed and groups created based on patients vitamin d level.
The outcomes for groups with vitamin d less than 50 nmol/L will be compared to those with levels at 50 nmol/L or greater. In addition, binary logistic regression will be used to determine the influence of vitamin d as a continuous variable on binary outcomes such as clinical pregnancy and live birth.
Control group
Active

Outcomes
Primary outcome [1] 318676 0
Presence of Clinical pregnancy as recorded in the PIVET Medical Centre database.
Timepoint [1] 318676 0
4 -5 weeks after embryo transfer
Primary outcome [2] 318677 0
Presence of live birth as recorded in the PIVET Medical Centre database.
Timepoint [2] 318677 0
more than 17 weeks after embryo transfer ( 20 weeks gestation).
Secondary outcome [1] 365671 0
Embryo grade as recorded in the PIVET Medical Centre database.
Timepoint [1] 365671 0
Day of embryo transfer
Secondary outcome [2] 365672 0
Number of oocytes retrieved as recorded in the PIVET Medical Centre database.
Timepoint [2] 365672 0
The number of oocytes retrieved will be assessed up to 3 months post oocyte collection/OPU. Normally this information is captured in our database within 2-3 days of transvaginal oocyte aspiration/OPU, but this extended time frame allows adequate time for data entry by embryological staff depending on workload.
Secondary outcome [3] 365673 0
The maturity of oocytes retrieved as recorded in the PIVET Medical Centre database.
Timepoint [3] 365673 0
The number of oocytes mature retrieved will be assessed up to 3 months post oocyte collection/OPU. Normally this information is captured in our database within 2-3 days of transvaginal oocyte aspiration/OPU, but this extended time frame allows adequate time for data entry by embryological staff depending on workload.
Secondary outcome [4] 365674 0
Fertilisation Rates as recorded in the PIVET Medical Centre database.
Timepoint [4] 365674 0
The fertilsation rate will be assessed up to 3 months post oocyte collection/OPU. Normally this information is captured in our database within 2-3 days of transvaginal oocyte aspiration/OPU, but this extended time frame allows adequate time for data entry by embryological staff depending on workload.

Eligibility
Key inclusion criteria
All eligible patients attending our IVF clinic consenting to the research and with a fresh embryo transfer.
Vitamin d tested with 90 days of embryo transfer.
Only the first chronological cycle for patients within the study time frame.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with no fresh embryo transfer cycles such as cancelled cycles, failed fertilisations, failed egg retrieval and freeze all cycles were excluded. Donor recipients (inclusive of semen, oocytes and embryos) were also excluded to minimise participant complexity in terms of the donor vs. recipient VitD status. Patients with a history of thyroid, renal, liver or metabolic disease. Patients with a vitamin d measurement more than 90 days before or after embryo transfer.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
SPSS analysis with Chi-square, ANOVA and t-test for means. Logistic regression applied to analyse influence of potential confounders

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 25366 0
6007 - West Leederville

Funding & Sponsors
Funding source category [1] 301640 0
Commercial sector/Industry
Name [1] 301640 0
PIVET Medical Centre
Address [1] 301640 0
166-168 Cambridge Street
Perth 6007
Western Australia
Country [1] 301640 0
Australia
Funding source category [2] 301641 0
Commercial sector/Industry
Name [2] 301641 0
Merck Serono
Address [2] 301641 0
3-4/25 Frenchs Forest Rd E., Frenchs Forest, NSW 2086
Country [2] 301641 0
Australia
Primary sponsor type
Hospital
Name
Perth Day Surgery centre
Address
166-168 Cambridge Street
Perth 6007
Western Australia
Country
Australia
Secondary sponsor category [1] 301349 0
None
Name [1] 301349 0
Address [1] 301349 0
Country [1] 301349 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302363 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 302363 0
Kent Street
Perth 6845
Western Australia
Ethics committee country [1] 302363 0
Australia
Date submitted for ethics approval [1] 302363 0
22/04/2010
Approval date [1] 302363 0
20/08/2010
Ethics approval number [1] 302363 0
RD-25-10

Summary
Brief summary
To determine the association between patient serum vitamin d status and clinical IVF outcomes such as clinical pregnancy and live births arising from fresh embryos transferred.
Our hypothesis is that those with a sufficient vitamin d status (> 50 nmol/L) will have more favourable outcomes in comparison to those with insufficient levels (< 50 nmol/L). We will examine vitamin d status as a continuous and as categorical variables while adjusting for various other infertility parameters including patient age and ovarian reserve.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89966 0
Dr Kevin Keane
Address 89966 0
School of Pharmacy and Biomedical Science, Curtin University, Bentley, Perth, WA 6102
Country 89966 0
Australia
Phone 89966 0
+61 8 92669781
Fax 89966 0
Email 89966 0
kevin.keane@curtin.edu.au
Contact person for public queries
Name 89967 0
Dr Kevin Keane
Address 89967 0
School of Pharmacy and Biomedical Science, Curtin University, Bentley, Perth, WA 6102
Country 89967 0
Australia
Phone 89967 0
+61 8 92669781
Fax 89967 0
Email 89967 0
kevin.keane@curtin.edu.au
Contact person for scientific queries
Name 89968 0
Dr Kevin Keane
Address 89968 0
School of Pharmacy and Biomedical Science, Curtin University, Bentley, Perth, WA 6102
Country 89968 0
Australia
Phone 89968 0
+61 8 92669781
Fax 89968 0
Email 89968 0
kevin.keane@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient confidentiality paramount.
However, non-disclosing data from the data-base can be made available.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1059 0
Ethical approval
Citation [1] 1059 0
Link [1] 1059 0
Email [1] 1059 0
Other [1] 1059 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary