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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02414737




Registration number
NCT02414737
Ethics application status
Date submitted
8/04/2015
Date registered
13/04/2015
Date last updated
21/06/2017

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
N/A
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
We would like to propose that it may be possible to use a solitary dose of Elonva
(corifollitrophin alpha) as the sole gonadotrophin (FSH) stimulant for the vast majority of
women undergoing IVF, assuming that it is possible that "coasting" (withholding short acting
rFSH) from day 8 of the stimulation until trigger/ oocyte retrieval will still result in a
significant number of mature oocytes being produced and an acceptable pregnancy rate.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02414737
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02414737