ANZCTR - Registration

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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]

N/A

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Infertility

Condition category

Condition code

Reproductive Health and Childbirth

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]

Not applicable

Comparator / control treatment

No Control Group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Pregnancy Rates (detection intrauterine gestational sac with foetal heart
beat at 7 weeks gestation)

Timepoint [1]

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]

Live Birth Rates (delivery of a live infant showing any sign of life, for instance heartbeat and voluntary movement)

Timepoint [2]

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]

Oocytes Retrieved (defined as the number of all oocytes retrieved following ovum pick up [OPU])

Timepoint [1]

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]

Oocyte Maturity (defined as the number of all oocytes retrieved demonstrating one polar body)

Timepoint [2]

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]

Fertilisation Rates (defined as the number of zygotes with 2 pronuclei after fertilisation as a proportion of all oocytes retrieved following OPU).

Timepoint [3]

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]

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]

Secondary outcome [5]

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]

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?

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)

Recruitment hospital [1]

Perth Day Surgery Centre - Leederville

Recruitment postcode(s) [1]

6007 - Leederville

Recruitment postcode(s) [2]

6007 - West Leederville

Funding & Sponsors

Funding source category [1]

University

Name [1]

Curtin University

Address [1]

Kent Street,
Bentley,
Perth,
WA 6102

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Merck Serono

Address [2]

3-4/25 Frenchs Forest Rd E.,
Frenchs Forest,
NSW 2086

Country [2]

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]

University

Name [1]

Curtin University

Address [1]

Curtin University,
Kent Street,
Bentley,
Perth,
WA6102

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University HREC

Ethics committee address [1]

Kent Street,
Bentley, 
Perth, 
WA6102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/11/2015

Approval date [1]

05/01/2016

Ethics approval number [1]

HR19-2016

Summary

Brief summary

Variability in oocyte quality is a major contributor to pregnancy rates during IVF . We wish to measure the concentration of various steroid and hormones including vitamin D in the follicle fluid and serum of IVF pateints during oocyte recovery and relate this to patient factors, stimulation and ovulation protocols to provide a better indication of their impact on oocyte and embryo quality and on pregnancy and implantation and live birth delivery rates.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof John L Yovich

Address

Perth Day Surgery Centre,
(PIVET Medical Centre),
Leederville,
Perth
WA 6007

Country

Australia

Phone

+ 61 8 9422 5400

Fax

[email protected]

Contact person for public queries

Name

Kevin Keane

Address

School of Biomedical Science,
Curtin University,
Bentley,
Perth,
WA 6102

Country

Australia

Phone

+ 61 8 9266 9781

Fax

[email protected]

Contact person for scientific queries

Name

Kevin Keane

Address

School of Biomedical Science,
Curtin University,
Bentley,
Perth,
WA 6102

Country

Australia

Phone

+ 61 8 9266 9781

Fax

[email protected]

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

[email protected]

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

Source	Title	Year of Publication	DOI
Embase	Serum Vitamin D status is associated with increased blastocyst development rate in women undergoing IVF.	2020	https://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.

Trial Review

Documents added manually

Documents added automatically