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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
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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
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Secondary ID [1]
312864
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N/A
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Universal Trial Number (UTN)
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Trial acronym
P4mNFET
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
In vitro fertilisation
335011
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Condition category
Condition code
Reproductive Health and Childbirth
331525
331525
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0
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Fertility including in vitro fertilisation
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
329408
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Treatment: Drugs
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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
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Control group
Historical
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Outcomes
Primary outcome [1]
339274
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Presence of corpus luteum
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Assessment method [1]
339274
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Transabdominal ultrasound on the day of embryo transfer
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Timepoint [1]
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Day of embryo transfer
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Secondary outcome [1]
439339
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Number of clinic visits
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Assessment method [1]
439339
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Absolute count of number of attendances to appointments (scans and/or blood tests) from day 1 up to and including day of embryo transfer which will be collected by auditing patient's electronic medical records.
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Timepoint [1]
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From day 1 of menses up to and including day of embryo transfer
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Secondary outcome [2]
439340
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Biochemical pregnancy rate
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Assessment method [2]
439340
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Blood tests for human chorionic gonadotrophin
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Timepoint [2]
439340
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10 days post embryo transfer
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Secondary outcome [3]
439341
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Clinical pregnancy rate
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Assessment method [3]
439341
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Transvaginal ultrasound to visualise a gestational sac
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Timepoint [3]
439341
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At 6-7 weeks of gestation
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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
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Minimum age
18
Years
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Maximum age
40
Years
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Sex
Females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
23/09/2024
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Actual
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Date of last participant enrolment
Anticipated
23/06/2025
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Actual
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Date of last data collection
Anticipated
23/09/2025
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Actual
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Sample size
Target
20
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
317309
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Hospital
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Name [1]
317309
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The Royal Women's Hospital
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Address [1]
317309
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Country [1]
317309
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Australia
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Primary sponsor type
Hospital
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Name
The Royal Women's Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
319633
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None
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Name [1]
319633
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Address [1]
319633
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Country [1]
319633
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316040
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The Royal Women's Hospital Human Research Ethics Committee
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Ethics committee address [1]
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https://www.thewomens.org.au/research/research-resources-and-ethics
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Ethics committee country [1]
316040
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Australia
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Date submitted for ethics approval [1]
316040
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01/05/2024
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Approval date [1]
316040
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17/07/2024
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Ethics approval number [1]
316040
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Summary
Brief summary
With advancements in cryopreservation techniques and widespread use of frozen embryo transfer (FET) in assisted reproductive technology, debate still exists around the optimal method for preparing the endometrium for embryo transfer. A protocol that achieves ovulation and gives a degree of flexibility to the timing of embryo transfer would be highly appealing to both patients and IVF clinics. The progesterone modified natural FET (P4mNFET) protocol has been proposed as one such method, whereby progesterone supplementation is commenced prior to ovulation, once certain ultrasound criteria are met. Given the relative paucity of data in the literature, this pilot study will recruit 20 women to undertake a P4mNFET in order to (a) confirm the presence/absence of a corpus luteum and (b) compare outcomes to a cohort undertaking a true natural FET.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Hector Georgiou
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Address
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Locked Bag 300, Public Fertility Care (level 2), The Royal Women's Hospital, Grattan Street and Flemington Road, Parkville, VIC, 3052
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Country
136586
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Australia
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Phone
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+61383453220
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Veronica Abruzzo
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Address
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Locked Bag 300, Public Fertility Care (level 2), The Royal Women's Hospital, Grattan Street and Flemington Road, Parkville, VIC, 3052
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Country
136587
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Australia
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Phone
136587
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+61 383453246
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Fax
136587
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Email
136587
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[email protected]
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Contact person for scientific queries
Name
136588
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Hector Georgiou
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Address
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Locked Bag 300, Public Fertility Care (level 2), The Royal Women's Hospital, Grattan Street and Flemington Road, Parkville, VIC, 3052
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Country
136588
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Australia
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Phone
136588
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+61383453220
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Fax
136588
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Email
136588
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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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.
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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.
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