Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001144505
Ethics application status
Approved
Date submitted
6/09/2024
Date registered
23/09/2024
Date last updated
23/09/2024
Date data sharing statement initially provided
23/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A cohort study to determine the presence of a corpus luteum in patients undertaking frozen embryo transfer and receiving pre-ovulation progesterone luteal phase support
Scientific title
A pilot cohort study of a progesterone modified natural protocol to determine the presence of a corpus luteum in patients undertaking frozen embryo transfer and receiving pre-ovulation progesterone luteal phase support
Secondary ID [1] 312864 0
N/A
Universal Trial Number (UTN)
Trial acronym
P4mNFET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
In vitro fertilisation 335011 0
Condition category
Condition code
Reproductive Health and Childbirth 331525 331525 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Progesterone 200mg vaginally twice daily, commencing on identification of a follicle with mean diameter of 14mm or more and endometrial thickness of 7mm or more, and continuing until 8 weeks of gestation.
Pessaries will be self-administered.
Adherence to the intervention will be monitored by tracking the return of the drug product.
Frozen embryo transfer is performed under transabdominal ultrasound guidance after 5 days of progesterone supplementation. This represents the same duration of progesterone treatment as clinic's routine true natural frozen embryo transfer protocol.
Intervention code [1] 329408 0
Treatment: Drugs
Comparator / control treatment
We will compare our secondary outcomes to 20 controls, matched against our inclusion criteria, who have competed a true natural FET cycle at the Public Fertility Care unit of The Royal Women's Hospital in the 12 months preceding the start of our study
Control group
Historical

Outcomes
Primary outcome [1] 339274 0
Presence of corpus luteum
Timepoint [1] 339274 0
Day of embryo transfer
Secondary outcome [1] 439339 0
Number of clinic visits
Timepoint [1] 439339 0
From day 1 of menses up to and including day of embryo transfer
Secondary outcome [2] 439340 0
Biochemical pregnancy rate
Timepoint [2] 439340 0
10 days post embryo transfer
Secondary outcome [3] 439341 0
Clinical pregnancy rate
Timepoint [3] 439341 0
At 6-7 weeks of gestation

Eligibility
Key inclusion criteria
Women who have regular menstrual cycles: 21-35 days.
Patients undertaking natural thaw of single embryo transfer attending the Public Fertility Services.
BMI 18-35.
Between 18-40 years of age.
No uterine pathology: congenital anomalies, endometrial polyps, intrauterine adhesions, adenomyosis, fibroids
Minimum age
18 Years
Maximum age
40 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Anovulatory women
Uterine pathology: congenital malformations, endometrial polyps, intrauterine adhesions, adenomyosis, fibroids
Women with contraindications to exogenous progesterone supplementation (eg., liver disease, thromboembolic disease)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/09/2024
Actual
Date of last participant enrolment
Anticipated
23/06/2025
Actual
Date of last data collection
Anticipated
23/09/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317309 0
Hospital
Name [1] 317309 0
The Royal Women's Hospital
Country [1] 317309 0
Australia
Primary sponsor type
Hospital
Name
The Royal Women's Hospital
Address
Country
Australia
Secondary sponsor category [1] 319633 0
None
Name [1] 319633 0
Address [1] 319633 0
Country [1] 319633 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316040 0
The Royal Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 316040 0
Ethics committee country [1] 316040 0
Australia
Date submitted for ethics approval [1] 316040 0
01/05/2024
Approval date [1] 316040 0
17/07/2024
Ethics approval number [1] 316040 0

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

Contacts
Principal investigator
Name 136586 0
Dr Hector Georgiou
Address 136586 0
Locked Bag 300, Public Fertility Care (level 2), The Royal Women's Hospital, Grattan Street and Flemington Road, Parkville, VIC, 3052
Country 136586 0
Australia
Phone 136586 0
+61383453220
Fax 136586 0
Email 136586 0
Hector.Georgiou@thewomens.org.au
Contact person for public queries
Name 136587 0
Veronica Abruzzo
Address 136587 0
Locked Bag 300, Public Fertility Care (level 2), The Royal Women's Hospital, Grattan Street and Flemington Road, Parkville, VIC, 3052
Country 136587 0
Australia
Phone 136587 0
+61 383453246
Fax 136587 0
Email 136587 0
veronica.abruzzo@thewomens.org.au
Contact person for scientific queries
Name 136588 0
Hector Georgiou
Address 136588 0
Locked Bag 300, Public Fertility Care (level 2), The Royal Women's Hospital, Grattan Street and Flemington Road, Parkville, VIC, 3052
Country 136588 0
Australia
Phone 136588 0
+61383453220
Fax 136588 0
Email 136588 0
Hector.Georgiou@thewomens.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No, as this does not constitute part of the study protocol. The study findings will be disseminated via presentation at relevant conferences and peer-reviewed publication.


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.