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Trial registered on ANZCTR


Registration number
ACTRN12617001221347
Ethics application status
Approved
Date submitted
7/08/2017
Date registered
21/08/2017
Date last updated
5/03/2020
Date data sharing statement initially provided
5/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Role of Vitamin D in Fertility and In Vitro Fertilisation (IVF) Outcomes
Scientific title
The impact of Vitamin D status on fertility outcomes, reproductive cell metabolism and bioenergetics.
Secondary ID [1] 292612 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 304292 0
Condition category
Condition code
Reproductive Health and Childbirth 303639 303639 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
The objective of this cross-sectional observational study is to examine the correlation between total Vitamin D levels in blood serum, follicular fluid and semen with various parameters of male and female fertility including oocytes generated, and rates of fertilisation, pregnancy, birth and miscarriage. In addition, in vitro/ex vivo investigations will be performed to determine the relationship between Vitamin D status, and the bioenergetic profile of sperm and granulosa cells.
For females, blood samples are routinely collected before and during IVF cycles to monitor estrogen and progesterone levels as per standard fertility assessment and treatment. An aliquot of these samples from consenting patients will be used to determine Vitamin D status (25 hydroxy vitamin D).
Follicular fluid and the granulosa cells within it will be collected from consenting patients as they undergo oocyte collection using transvaginal oocyte aspriation at the clinic.
For consenting males, an aliquot of semen will be collected for vitamin D testing and sperm testing following assessment of diagnostic semen parameters and/or insemination of all oocytes retrieved, Therefore the sample that is tested for Vitamin D and sperm function as part of this study is not required for further patient tests or use.

To assess the lengthiest outcome, live birth rate, patient data will be observed up to 12 months (1 year), so that live birth outcomes can be recorded.
Intervention code [1] 298824 0
Not applicable
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302999 0
Pregnancy Rates (detection intrauterine gestational sac with foetal heart
beat at 7 weeks gestation)
Timepoint [1] 302999 0
Detection of intrauterine gestational sac with foetal heart using ultrasound is conducted at 7-8 weeks gestation or 7-8 post embryo transfer.
Primary outcome [2] 303000 0
Live Birth Rates (delivery of a live infant showing any sign of life, for instance heartbeat and voluntary movement)
Timepoint [2] 303000 0
To determine whether or not a live birth has occurred, primary outcome [2] will be followed up from 9 months to 1 year after embryo transfer. This is due to the fact that after detection of a pregnancy, female patients come under the care of their selected obstetrician and selected maternity hospital. The timepoint described above allows adequate time for the return of clinical information about the live birth outcomes from the maternity hospital to the IVF clinic.
Secondary outcome [1] 337653 0
Oocytes Retrieved (defined as the number of all oocytes retrieved following ovum pick up [OPU])
Timepoint [1] 337653 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 [2] 337691 0
Oocyte Maturity (defined as the number of all oocytes retrieved demonstrating one polar body)
Timepoint [2] 337691 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 [3] 337692 0
Fertilisation Rates (defined as the number of zygotes with 2 pronuclei after fertilisation as a proportion of all oocytes retrieved following OPU).
Timepoint [3] 337692 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.
Secondary outcome [4] 337693 0
Fertilisation Rates (defined as the number of zygotes with 2 pronuclei after fertilisation as a proportion of all mature oocytes (M2) retrieved following OPU).
Timepoint [4] 337693 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.
Secondary outcome [5] 337972 0
Utilisation Rates (defined as the total number of embryos cryopreserved or transferred back to the patient as a proportion of all oocytes retrieved or as a proportion of all mature oocytes (M2) retrieved following OPU).
Timepoint [5] 337972 0
Utilisation rates 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with a history of thyroid, renal, liver or metabolic disease.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Logistic regression for binary outcomes

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/08/2017
Date of last participant enrolment
Anticipated
31/12/2018
Actual
21/11/2018
Date of last data collection
Anticipated
5/12/2019
Actual
21/11/2019
Sample size
Target
500
Accrual to date
Final
455
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 8700 0
Perth Day Surgery Centre - Leederville
Recruitment postcode(s) [1] 16812 0
6007 - Leederville
Recruitment postcode(s) [2] 16813 0
6007 - West Leederville

Funding & Sponsors
Funding source category [1] 297199 0
University
Name [1] 297199 0
Curtin University
Country [1] 297199 0
Australia
Funding source category [2] 297201 0
Commercial sector/Industry
Name [2] 297201 0
Merck Serono
Country [2] 297201 0
Australia
Primary sponsor type
Hospital
Name
Perth Day Surgery Centre
Address
Perth Day Surgery Centre
(PIVET Medical Centre),
Leederville,
Perth,
WA6007
Country
Australia
Secondary sponsor category [1] 296207 0
University
Name [1] 296207 0
Curtin University
Address [1] 296207 0
Curtin University,
Kent Street,
Bentley,
Perth,
WA6102
Country [1] 296207 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298355 0
Curtin University HREC
Ethics committee address [1] 298355 0
Ethics committee country [1] 298355 0
Australia
Date submitted for ethics approval [1] 298355 0
10/11/2015
Approval date [1] 298355 0
05/01/2016
Ethics approval number [1] 298355 0
HR19-2016

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76822 0
Prof John L Yovich
Address 76822 0
Perth Day Surgery Centre,
(PIVET Medical Centre),
Leederville,
Perth
WA 6007
Country 76822 0
Australia
Phone 76822 0
+ 61 8 9422 5400
Fax 76822 0
Email 76822 0
jlyovich@pivet.com.au
Contact person for public queries
Name 76823 0
Kevin Keane
Address 76823 0
School of Biomedical Science,
Curtin University,
Bentley,
Perth,
WA 6102
Country 76823 0
Australia
Phone 76823 0
+ 61 8 9266 9781
Fax 76823 0
Email 76823 0
kevin.keane@curtin.edu.au
Contact person for scientific queries
Name 76824 0
Kevin Keane
Address 76824 0
School of Biomedical Science,
Curtin University,
Bentley,
Perth,
WA 6102
Country 76824 0
Australia
Phone 76824 0
+ 61 8 9266 9781
Fax 76824 0
Email 76824 0
kevin.keane@curtin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
individual participant data underlying published results only
When will data be available (start and end dates)?
30 December 2020 - 30 June 2021
Available to whom?
Researchers of third level institutes who provide a methodologically sound proposal
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
access subject to approvals by Principal Investigator

kevin.keane@curtin.edu.au


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSerum Vitamin D status is associated with increased blastocyst development rate in women undergoing IVF.2020https://dx.doi.org/10.1016/j.rbmo.2020.08.014
N.B. These documents automatically identified may not have been verified by the study sponsor.