Fertility DisordersNCT03156374
Timing Frozen Embryo Transfer by Following Two Different Methods
A study testing Test use in people with Fertility Disorders, run by SPD Development Company Limited at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Disorders
- What is being tested?
- Test use
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Apr 2017to 30 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
IVFAustralia - Bondi Junction
Bondi Junction, New South Wales, NSW 2022
About this study
Official title: Proof of Concept Study To Assess Women's Likability and Stress in Timing Frozen Embryo Transfer by Following Two Different Methods
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.
Read the detailed description
The study will evaluate the ability of home ovulation tests to accurately time Frozen Embryo Transfer (FET) directly compared to standard clinical procedures. In addition, women's likability and stress associated with timing a FET cycle using both methods will be evaluated by collecting qualitative data using standardised questionnaires.
The impact of psychological stress on FET outcome such as implantation rates and viability at first scan will be considered in order to gather information for the design of a larger clinical study and basic financial data will also be collected, in order to pilot a cost-effectiveness evaluation of the two FET timing methods.
A subset of volunteers will collect daily urine samples from day after embryo transfer until confirmation of pregnancy.
- Conditions
- Fertility Disorders
- Being tested
- Test use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test useDevice
Use of home ovulation test to predict ovulation
| Study group | Role | What they receive |
|---|---|---|
| Ovulation test use | Experimental | Use of both ovulation tests and standardised care Receives: Device: Test use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of volunteers where ADOT use enables equivalent timing of FET compared to clinic visit
Examination as to whether using ADOT would have enabled correct timing of FET when compared to clinic visit
Measured: 9 months
Secondary outcomes (3)
Measurement of women's psychological distress
Use of validated questionnaire to assess stress level
Measured: 9 months
Positive and negative experience in using ovulation tests in FET
Qualitative assessment of women's FET treatment experience when using ADOT compared to standard clinical procedures during the study via a semi-structured interview following embryo transfer
Measured: 9 months
FET success
Implantation rate
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start30 Apr 2017
- Primary completion28 Aug 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Parallel use of ovulation test and standard hospital monitoring, for agreement of methods
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156374
- Sponsor's protocol ID
- PROTOCOL-0897
- Status last verified
- Feb 2021
- First submitted
- 28 Apr 2017
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept Study To Assess Women's Likability and Stress in Timing Frozen Embryo Transfer by Following Two Different Methods
- ClinicalTrials.gov ID
- NCT03156374
- Acronym / sponsor ID
- PROTOCOL-0897
- Conditions
- Fertility Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2017 (actual)
- Primary completion
- 28 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 17 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will evaluate the ability of home ovulation tests to accurately time Frozen Embryo Transfer (FET) directly compared to standard clinical procedures. In addition, women's likability and stress associated with timing a FET cycle using both methods will be evaluated by collecting qualitative data using standardised questionnaires.
The impact of psychological stress on FET outcome such as implantation rates and viability at first scan will be considered in order to gather information for the design of a larger clinical study and basic financial data will also be collected, in order to pilot a cost-effectiveness evaluation of the two FET timing methods.
A subset of volunteers will collect daily urine samples from day after embryo transfer until confirmation of pregnancy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Parallel use of ovulation test and standard hospital monitoring, for agreement of methods
| Arm | Type | Receives |
|---|---|---|
| Ovulation test use | Experimental | Device: Test useUse of both ovulation tests and standardised care |
Who may qualify
- Ages
- 24 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test useUse of home ovulation test to predict ovulation | Device | Ovulation test use |
Primary outcome
Proportion of volunteers where ADOT use enables equivalent timing of FET compared to clinic visit
Time frame: 9 months
Examination as to whether using ADOT would have enabled correct timing of FET when compared to clinic visit
3 secondary outcomes
Measurement of women's psychological distress
Time frame: 9 months
Positive and negative experience in using ovulation tests in FET
Time frame: 9 months
FET success
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Test use in people with Fertility Disorders, run by SPD Development Company Limited at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of volunteers where ADOT use enables equivalent timing of FET compared to clinic visit (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.