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Trial registered on ANZCTR


Registration number
ACTRN12618001820291
Ethics application status
Approved
Date submitted
31/10/2018
Date registered
8/11/2018
Date last updated
8/11/2018
Date data sharing statement initially provided
8/11/2018
Date results information initially provided
8/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
This study investigates the relevance of male age and male factors impacting on the chance of live births from in vitro fertilization treatment cycles
Scientific title
This retrospective cohort study investigates the outcomes of 1280 in vitro fertilization treatment cycles with respect to considering the relevance of male age and semen parameters
Secondary ID [1] 296482 0
NIl Known
Secondary ID [2] 296503 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility treated by in vitro fertilisation 310266 0
Condition category
Condition code
Reproductive Health and Childbirth 308997 308997 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
This study looks at the outcomes for couples with infertility where in vitro fertilisation treatment was applied. The study was retrospective and conducted over the period 1st April 2008 to 30th November 2017. During this period 4173 autologous treatment cycles by in vitro fertilisation were undertaken and, after exclusions, this study focussed on 1280 treatment cycles examining the effect of male age and sperm parameters on clinical pregnancy and live birth rates in fresh IVF cycles.
Intervention code [1] 312805 0
Not applicable
Comparator / control treatment
Comparisons were made between several age groups of the male and the female patients as well as combinations of old vs young patients.
Control group
Historical

Outcomes
Primary outcome [1] 307956 0
clinical pregnancy defined as elevated serum ßhCG and vaginal ultrasound showing intra-uterine gestational sac.
Timepoint [1] 307956 0
35 days after oocyte pick-up
Primary outcome [2] 307978 0
Live birth – data-linkage to medical records in clinic database compiled from patient information and hospital records by a single coordinating nurse, who contacts each patient within 7 days of their expected due date
Timepoint [2] 307978 0
>18 weeks after oocyte pick-up ( by convention this means gestation >20 weeks).
Secondary outcome [1] 353470 0
sperm concentration (total number of spermatozoa /ml
Timepoint [1] 353470 0
within 3 months before start of IVF cycle
Secondary outcome [2] 353693 0
sperm motility (WHO progressive motility A and B grades) /ml
Timepoint [2] 353693 0
within 3 months before start of IVF cycle
Secondary outcome [3] 353694 0
sperm morphology (WHO strict criteria) /ml
Timepoint [3] 353694 0
within 3 months before start of IVF cycle
Secondary outcome [4] 353695 0
DNA fragmentation index (Halo test) % failing to display halo
Timepoint [4] 353695 0
within 3 months before start of IVF cycle

Eligibility
Key inclusion criteria
all first fresh autologous cycles in heterozygous couples undergoing IVF with single embryo transfer.
Female ages ranged 22 years to 48 years
Male ages ranged 23 years to 64 years
Minimum age
22 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
donor cycles using donor gametes
frozen cycles
natural cycles
assessment cycles and other types of fertility treatments such as IUI
azoospermic males

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Analysis done using SPSS - ANOVA and chi squared, as well as univariate and multiple logistic regression

Recruitment
Recruitment status
Active, not recruiting
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] 24552 0
6007 - West Leederville

Funding & Sponsors
Funding source category [1] 301071 0
Self funded/Unfunded
Name [1] 301071 0
Address [1] 301071 0
Country [1] 301071 0
Primary sponsor type
Other
Name
PIVET medical centre
Address
166-168 Cambridge Street
Leederville 6007
Western Australia
Country
Australia
Secondary sponsor category [1] 300679 0
None
Name [1] 300679 0
Address [1] 300679 0
Country [1] 300679 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301825 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 301825 0
Curtin University,
Kent Street, Bentley
Perth 6845
Western Australia
Ethics committee country [1] 301825 0
Australia
Date submitted for ethics approval [1] 301825 0
Approval date [1] 301825 0
31/08/2003
Ethics approval number [1] 301825 0
RD-25-10

Summary
Brief summary
This study looks at the male age effect on the sperm parameters and the clinical pregnancy and live birth rates in an IVF cycle. We included heterozygous couples using autologous gametes in their first fresh IVF cycle. We only included patients who had single embryo transfer.
Trial website
Trial related presentations / publications
Public notes
Curtin University approval to publish retrospective data was first obtained 31 August 2003, updated 2008, then 2010, 2015 and 2018. Initial approval by Curtin HREC 185/2003 functioned to December 2008. Current approval RD-25-10 active to 2019

Contacts
Principal investigator
Name 88234 0
Prof John Yovich
Address 88234 0
PIVET Medical Centre
166-168 Cambridge street
Perth 6007
Western Australia
Country 88234 0
Australia
Phone 88234 0
+61 08 9422 5400
Fax 88234 0
+61 08 9382 4576
Email 88234 0
jlyovich@pivet.com.au
Contact person for public queries
Name 88235 0
Prof John Yovich
Address 88235 0
PIVET Medical Centre
166-168 Cambridge street
Perth 6007
Western Australia
Country 88235 0
Australia
Phone 88235 0
+61 08 9422 5400
Fax 88235 0
+61 08 9382 4576
Email 88235 0
jlyovich@pivet.com.au
Contact person for scientific queries
Name 88236 0
Prof John Yovich
Address 88236 0
PIVET Medical Centre
166-168 Cambridge street
Perth 6007
Western Australia
Country 88236 0
Australia
Phone 88236 0
+61 08 9422 5400
Fax 88236 0
+61 08 9382 4576
Email 88236 0
jlyovich@pivet.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is simply an observational study of routine clinical practice. This functions under Accrediation from RTAC (Reproductive Technology Accreditation Committee) with a Code of Practice 2017, developed under the auspices of the Fertility Society of Australia.

Privacy and confidentiality required for all participants (patients)
What supporting documents are/will be available?
No other documents available
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