Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001933246
Ethics application status
Approved
Date submitted
9/11/2018
Date registered
28/11/2018
Date last updated
28/11/2018
Date data sharing statement initially provided
28/11/2018
Date results information initially provided
28/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Do frozen embryos generated under the influence of growth hormone implant at a higher rate?
Scientific title
Implantation potential and pregnancy outcomes of vitrified-autologous embryos generated under growth hormone stimulation
Secondary ID [1] 296565 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infertility 310349 0
Condition category
Condition code
Reproductive Health and Childbirth 309083 309083 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 frozen embryo transfer treatment cycles initiated from 1st April 2008 to 31st March 2017 were retrospectively extracted from PIVET Medical Centre’s long-established, validated database where growth hormone or other adjuvants were used. The data 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] 312871 0
Not applicable
Comparator / control treatment
All frozen embryo transfer treatment cycles initiated from 1st April 2008 to 31st March 2017 at PIVET Medical Centre where no adjuvants were used.
Control group
Historical

Outcomes
Primary outcome [1] 308049 0
Pregnancies were diagnosed at PIVET Medical Center and categorised as “clinical” if an intra-uterine gestational sac was shown 4-5 weeks after embryo transfer.
Timepoint [1] 308049 0
4 -5 weeks after embryo transfer
Primary outcome [2] 308050 0
Live births were patient-reported by follow-up at PIVET Medical Center and cross-checked with formal reporting by the attending obstetrician; thereafter categorised as live birth if delivery of at least one live infant occurred after 20 weeks gestation.
Timepoint [2] 308050 0
more than 17 weeks after embryo transfer ( 20 weeks gestation).
Primary outcome [3] 308051 0
Miscarriage was patient-reported by follow-up at PIVET Medical Center and cross-checked with formal reporting by the attending obstetrician or gynaecologist; thereafter categorised as miscarriage if no live infant was delivered at any stage after the diagnosis of pregnancy.
Timepoint [3] 308051 0
4 to 18 weeks after embryo transfer
Secondary outcome [1] 353834 0
Embryo gradings were rated as high, mid-range and low for blastocysts according to PIVET's modification of Gardner grading which categorises trophectoderm and inner cell mass characteristics. Cleavage-stage embryos were graded as high or low according to PIVET’s long-standing grading system based on blastomere numbers and features along with degree of fragmentation.
Timepoint [1] 353834 0
Day of embryo transfer

Eligibility
Key inclusion criteria
Of 2518 frozen embryo transfer cycles conducted during the time frame, included all 1119 vitrified embryos undergoing first treatment cycle with single embryo transfer applying an HRT shedule.
Minimum age
20 Years
Maximum age
48 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Natural cycles and stimulated cycles. double embryo transfers and repeat FET cycles.

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
1/02/2018
Date of last participant enrolment
Anticipated
Actual
31/03/2018
Date of last data collection
Anticipated
Actual
31/03/2018
Sample size
Target
2518
Accrual to date
Final
1119
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 24647 0
6007 - West Leederville

Funding & Sponsors
Funding source category [1] 301143 0
Other
Name [1] 301143 0
PIVET Medical Centre
Country [1] 301143 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] 300763 0
None
Name [1] 300763 0
Address [1] 300763 0
Country [1] 300763 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301893 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 301893 0
Kent Street
Perth 6845
Western Australia
Ethics committee country [1] 301893 0
Australia
Date submitted for ethics approval [1] 301893 0
22/04/2010
Approval date [1] 301893 0
20/08/2010
Ethics approval number [1] 301893 0
RD-25-10

Summary
Brief summary
To determine the clinical pregnancy and live births arising from frozen embryos transferred (FET) which had been generated under the influence of IVF adjuvants given to women categorised as poor prognosis.
Our hypothesis is that growth hormone, but not other adjuvants, administered in stimulation cycles may improve oocytes with resultant benefits to embryo quality which in turn may result in improved Clinical Pregnancy and Live Birth rates in subsequent FET cycles.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88458 0
Prof John Yovich
Address 88458 0
PIVET Medical Centre
166-168 Cambridge Street
Perth 6007
Western Australia
Country 88458 0
Australia
Phone 88458 0
+61 08 9422 5400
Fax 88458 0
+61 08 9382 4576
Email 88458 0
[email protected]
Contact person for public queries
Name 88459 0
Prof John Yovich
Address 88459 0
PIVET Medical Centre
166-168 Cambridge Street
Perth 6007
Western Australia
Country 88459 0
Australia
Phone 88459 0
+61 08 9422 5400
Fax 88459 0
+61 08 9382 4576
Email 88459 0
[email protected]
Contact person for scientific queries
Name 88460 0
Prof John Yovich
Address 88460 0
PIVET Medical Centre
166-168 Cambridge Street
Perth 6007
Western Australia
Country 88460 0
Australia
Phone 88460 0
+61 08 9422 5400
Fax 88460 0
+61 08 9382 4576
Email 88460 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
270Ethical approval    376350-(Uploaded-15-11-2018-14-42-14)-Study-related document.pdf



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.