Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000943448
Ethics application status
Approved
Date submitted
21/07/2025
Date registered
29/08/2025
Date last updated
29/08/2025
Date data sharing statement initially provided
29/08/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
A retrospective cohort study describing the real-world use of follitropin delta for ovulation induction (prior to intrauterine insemination or frozen embryo transfer) in Australia
Scientific title
A retrospective cohort study describing the real-world use of follitropin delta for ovulation induction (prior to intrauterine insemination or frozen embryo transfer) in Australia
Secondary ID [1] 314754 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 337970 0
Anovulation 338479 0
Condition category
Condition code
Reproductive Health and Childbirth 334286 334286 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
Patients were prescribed follitropin delta (does was varied and patient dependent) to induce ovulation prior to an intrauterine insemination or frozen embryo transfer. The outcome of the cycle was recorded. Data was collect from day 1 of patients period, at time of ovulation, through till pregnancy test (approx 30 days). Blood samples, scan reports and patient files were reviewed to obtain required information. The Dr notes, patient files and City Fertility and Coastal IVF databases were used to obtain patient results. These patients had treatment between 4/5/2020 and 4/3/2025. Collection commenced on day of ethics approval 30/4/25
Intervention code [1] 331405 0
Not applicable
Comparator / control treatment
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342043 0
safety of follitropin delta.
Timepoint [1] 342043 0
because this is a retrospective we are assessing from start of fertility treatment till pregnancy test. This period is approximately 1 month
Secondary outcome [1] 449408 0
effectiveness of follitropin delta through detection of LH surge on blood test
Timepoint [1] 449408 0
because this is a retrospective we are assessing from start of fertility treatment till pregnancy test, approximately 1 month.
Secondary outcome [2] 450729 0
effectiveness of follitropin delta is determined by positive pregnancy test
Timepoint [2] 450729 0
because this is a retrospective we are assessing from start of fertility treatment till pregnancy test, approximately 1 month.

Eligibility
Key inclusion criteria
Any patient that started an intrauterine insemination or frozen embryo transfer cycle using follitropin delta at City Fertility Sydney CBD or Coastal IVF
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
no exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
30/04/2025
Date of last participant enrolment
Anticipated
Actual
30/04/2025
Date of last data collection
Anticipated
16/12/2025
Actual
Sample size
Target
200
Accrual to date
Final
318
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 319304 0
Commercial sector/Industry
Name [1] 319304 0
Ferring
Country [1] 319304 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ferring
Address
Country
Australia
Secondary sponsor category [1] 321927 0
None
Name [1] 321927 0
Address [1] 321927 0
Country [1] 321927 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317883 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 317883 0
Ethics committee country [1] 317883 0
Australia
Date submitted for ethics approval [1] 317883 0
Approval date [1] 317883 0
30/04/2025
Ethics approval number [1] 317883 0

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

Contacts
Principal investigator
Name 142458 0
A/Prof William Ledger
Address 142458 0
City Fertility, Level 18, 1 Macquarie Place, Sydney, NSW 2000
Country 142458 0
Australia
Phone 142458 0
+41 045798853
Fax 142458 0
Email 142458 0
[email protected]
Contact person for public queries
Name 142459 0
Molly Toogood
Address 142459 0
City Fertility, Level 18, 1 Macquarie Place, Sydney, NSW 2000
Country 142459 0
Australia
Phone 142459 0
+41 0409179390
Fax 142459 0
Email 142459 0
[email protected]
Contact person for scientific queries
Name 142460 0
Molly Toogood
Address 142460 0
City Fertility, Level 18, 1 Macquarie Place, Sydney, NSW 2000
Country 142460 0
Australia
Phone 142460 0
+41 0409179390
Fax 142460 0
Email 142460 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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
No additional documents have been identified.