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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02414737




Registration number
NCT02414737
Ethics application status
Date submitted
8/04/2015
Date registered
13/04/2015

Titles & IDs
Public title
Ovarian Stimulation Single Injection Elonva
Scientific title
Ovarian Stimulation Single Injection Elonva- The OSSIE Study
Secondary ID [1] 0 0
AU/1/2 C8B110
Universal Trial Number (UTN)
Trial acronym
OSSIE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - corifollitrophin alfa

Experimental: corifollitrophin alfa - corifollitrophin alfa used as COH stimulant in IVF


Treatment: Drugs: corifollitrophin alfa
use of a single dose of corifollitrophin alfa to provide adequate controlled ovarian hyperstimulation during IVF treatment
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Oocyte maturity - number of mature oocytes (metaphase II oocytes) retrieved in IVF cycle
Timepoint [1] 0 0
IVF cycle (2 weeks approximately)

Eligibility
Key inclusion criteria
* Undergoing a GnRH antagonist cycle of IVF as part of their personal fertility treatment
* Eligible for the use of the 150 mcg dose of Elonva according to Australian PBS requirements (weight > 60 kg, antral follicle count < 20)
* Intention of undergoing a fresh embryo transfer.
* No major sperm quality issues (ejaculate sperm concentration > 5 million/ ml, motility > 25% neat sample). ICSI for the indication of poor morphology would be acceptable for trial enrollment.
* Maternal age 18-37 years inclusive.
Minimum age
18 Years
Maximum age
37 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Low ovarian reserve (antral follicle count 2-10 mm < 7, early follicular phase FSH > 10 IU/L, < 4 oocytes prior IVF cycle on a dose of rFSH > 150 IU).
* Ovarian pathology (PCOS, ovarian cyst, endometrioma, poor trans-vaginal ultrasound ovary access).
* 2 or more previous cycles of IVF (stimulated cycles) in which a live birth pregnancy did not result, or one prior stimulated cycle of IVF and 2 or more frozen embryo transfer cycles without a live birth outcome (possible implantation failure).
* Significant pelvic pathology likely to impair embryo implantation (fibroids, polyps, uterine septum, hydrosalpinx).
* Intention to freeze all embryos with nil fresh transfer (pre-implantation genetic screening, oncology fertility preservation).
* Known renal impairment
* Use of a long down regulation or "flare" IVF protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2017
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders Fertility - Bedford Park
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Flinders Fertility
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Flinders University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Kelton Tremellen, MD PhD
Address 0 0
Flinders University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02414737