Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03156374




Registration number
NCT03156374
Ethics application status
Date submitted
28/04/2017
Date registered
17/05/2017
Date last updated
8/02/2021

Titles & IDs
Public title
Timing Frozen Embryo Transfer by Following Two Different Methods
Scientific title
Proof of Concept Study To Assess Women's Likability and Stress in Timing Frozen Embryo Transfer by Following Two Different Methods
Secondary ID [1] 0 0
PROTOCOL-0897
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fertility Disorders 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Test use

Experimental: Ovulation test use - Use of both ovulation tests and standardised care


Treatment: Devices: Test use
Use of home ovulation test to predict ovulation
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of volunteers where ADOT use enables equivalent timing of FET compared to clinic visit
Timepoint [1] 0 0
9 months
Secondary outcome [1] 0 0
Measurement of women's psychological distress
Timepoint [1] 0 0
9 months
Secondary outcome [2] 0 0
Positive and negative experience in using ovulation tests in FET
Timepoint [2] 0 0
9 months
Secondary outcome [3] 0 0
FET success
Timepoint [3] 0 0
9 months

Eligibility
Key inclusion criteria
* Women aged 24 to 45 years of age
* Undergoing no more than 5frozen embryo transfer
* Average cycle length between 26 and 35 days
* Willing to provide written informed consent to participate in the study and comply with all study procedures
Minimum age
24 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* More than five IVF frozen embryo cycle
* Undergoing FET following cancer treatment
* Self-reported drug or alcohol dependency
* Self-reported history of depression, anxiety and panic attacks

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
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
Not applicable
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
30/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2019
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
IVFAustralia - Bondi Junction - Bondi Junction
Recruitment postcode(s) [1] 0 0
NSW 2022 - Bondi Junction

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
SPD Development Company Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This proof of concept study is designed to determine the practicality of using home ovulation tests to enable optimum timing for transfer of frozen embryos in a natural menstrual cycle in comparison to the standard ultrasound and serum monitoring currently conducted by many IVF clinics.
Trial website
https://clinicaltrials.gov/study/NCT03156374
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/study/NCT03156374