Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000453482
Ethics application status
Approved
Date submitted
14/02/2025
Date registered
14/05/2025
Date last updated
14/05/2025
Date data sharing statement initially provided
14/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Identifying Factors Contributing to Variability in the Ovarian Response to Follicle Stimulating Drugs among Women Undergoing In-Vitro Fertilisation (IVF)
Scientific title
Identifying Patient and Pharmacological Factors Contributing to Variability in the Ovarian Response to FSH Stimulating Drugs among Women Undergoing In-Vitro Fertilisation (IVF)
Secondary ID [1] 313828 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
infertility 336473 0
Condition category
Condition code
Reproductive Health and Childbirth 332991 332991 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
Women undergoing controlled ovarian hyperstimulation for in vitro fertilisation will be prescribed follitropin alfa by their prescribing clinician. Follitropin alfa is a commonly prescribed IVF medication, and will be offered to IVF patients regardless of study involvement, unless another gonadotrophin (such as follitropin beta) is preferred by the prescriber. The dose of follitropin alfa will be at the discretion of the clinician (independent from the study) and is not standardised, however a once daily administration is common. Dosing information will be collected by the study investigators.

Standard Care Participation: As part of routine IVF care, blood samples are collected for each participant's fertility treatment. At the same time that these samples are drawn, an additional sample will be collected for research purposes, including genetic analysis. These samples will be collected on: the day of starting follitropin alfa, five days after starting follitropin alfa, and the day of ovum pick up.
Total number of blood samples: 3

Enhanced Participation: Participants are invited to opt into an enhanced level of participation, where they undergo two additional blood samples (as well as the blood samples taken in line with Standard Care Participation). Enhanced participation is offered to all participants, until the allocated sample size is reached (N=50). The first additional sample will be between five days after starting follitropin alfa and the day prior to administering the ovulation trigger shot. The second additional sample will be on the day of the ovulation trigger shot.
Total number of blood samples: 5
Intervention code [1] 330417 0
Not applicable
Comparator / control treatment
There is no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340529 0
Number of retrieved oocytes
Timepoint [1] 340529 0
Day of ovum pick up
Secondary outcome [1] 444392 0
Frequency of genetic variants (composite secondary outcome). The genetic variants of interest are unknown, which is the purpose of conducting Whole Genome Sequencing.
Timepoint [1] 444392 0
The day of starting follitropin alfa.
Secondary outcome [2] 444393 0
Concentration of known ovarian response biomarkers (composite secondary outcome: follicle-stimulating hormone, estradiol, luteinizing hormone, progesterone, inhibin-B).
Timepoint [2] 444393 0
Standard care participation: The day of starting follitropin alfa, Day 5 of taking follitropin alfa, the day of ovum pick up. Enhanced participation: The day of starting follitropin alfa, Day 5 of taking follitropin alfa, between day 5 and ovulation trigger shot, the day of ovulation trigger shot, the day of ovum pick up.

Eligibility
Key inclusion criteria
Willingness to provide written informed consent as part of study participation
Proficient in the English language
Currently receiving treatment at participating sites
Prescribed follitropin alfa for controlled ovarian stimulation, at any dose, prior to treatment initiation
Any cycle of IVF ± intracytoplasmic sperm injection (ICSI)
Participants are eligible for recruitment for multiple cycles until a successful pregnancy outcome
Aged between 18 and 46 years old
BMI less than 35 kg/m2
Participants undergoing ovarian stimulation for elective fertility preservation
Minimum age
18 Years
Maximum age
46 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to provide written informed consent
Morphologically abnormal or absent ovary
Women with known endocrine, genetic, systematic inflammatory-immunological disorders
Women with hypothalamic dysfunction, history of endometriosis with ovarian surgery, history of ovarian surgery, or a history of pelvic radiotherapy and/or chemotherapy

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
300 women will be enrolled into this study. Of which, 50 women will be enrolled in Enhanced Participation.
Given that this is an observational study, the analysis will primarily focus on exploratory statistics to understand variability in ovarian response (number of retrieved oocytes) to follitropin alfa administration (FSH stimulation).

Descriptive statistics will summarise baseline characteristics and hormonal levels, while inferential statistics will identify associations between patient-level data, genetic variants, and pharmacological factors with the primary and secondary outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/02/2025
Date of last participant enrolment
Anticipated
11/08/2025
Actual
Date of last data collection
Anticipated
15/09/2025
Actual
Sample size
Target
300
Accrual to date
37
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 318299 0
Government body
Name [1] 318299 0
Department of Health and Aged Care: Medical Research Future Fund
Country [1] 318299 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 320699 0
None
Name [1] 320699 0
Address [1] 320699 0
Country [1] 320699 0
Other collaborator category [1] 283380 0
Commercial sector/Industry
Name [1] 283380 0
Virtus Health Pty Ltd
Address [1] 283380 0
Country [1] 283380 0
Australia
Other collaborator category [2] 283410 0
Commercial sector/Industry
Name [2] 283410 0
23Strands Pty Ltd
Address [2] 283410 0
Country [2] 283410 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316936 0
IVF Australia Ethics Committee
Ethics committee address [1] 316936 0
Ethics committee country [1] 316936 0
Australia
Date submitted for ethics approval [1] 316936 0
07/08/2024
Approval date [1] 316936 0
31/10/2024
Ethics approval number [1] 316936 0

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

Contacts
Principal investigator
Name 139482 0
A/Prof Gavin Sacks
Address 139482 0
IVF Australia, Level 2, 176 Pacific Highway, Greenwich New South Wales 2065
Country 139482 0
Australia
Phone 139482 0
+610283059800
Fax 139482 0
Email 139482 0
[email protected]
Contact person for public queries
Name 139483 0
Franca Agresta
Address 139483 0
Melbourne IVF, 36 Wellington Street, Collingwood, Victoria, 3066
Country 139483 0
Australia
Phone 139483 0
+610394734570
Fax 139483 0
Email 139483 0
[email protected]
Contact person for scientific queries
Name 139484 0
A/Prof. Sophie Stocker
Address 139484 0
The University of Sydney, Pharmacy and Bank Building, Science Road, The University of Sydney, Camperdown 2006, NSW Australia
Country 139484 0
Australia
Phone 139484 0
+610290366401
Fax 139484 0
Email 139484 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.