Fertility IssuesMIRANCT06410170
Correlation of Urinary and Serum Hormone Levels in Natural Cycle Frozen Embryo Transfer Cycles
An observational study of Fertility Issues, run by Ottawa Fertility Centre at 1 site in Canada.
Trial summary
To evaluate whether the measurement of urinary estrone glucuronide and luteinizing hormone (LH) concentrations with an at-home device is correlated with serum hormone levels within a natural cycle frozen embryo transfer protocol. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Issues
- What is being tested?
- MIRA Device
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2024to Dec 2025
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants that are presenting for a natural cycle frozen embryo transfer at The Ottawa and Olive Fertility Centre's
Who may be able to join
- All patients scheduled for a natural cycle frozen embryo transfer
- Agree to participate in the research study
Who cannot join
- There are no exclusions
Trial locations and contacts
1 site in 1 country.
Canada1 site
Olive Fertility Centre
Vancouver, British Columbia, V5Z 3X7
Gary Nakhuda, MD, 604-559-9950
Gary Nakhuda, MD
About this study
To evaluate whether the measurement of urinary estrone glucuronide and luteinizing hormone (LH) concentrations with an at-home device is correlated with serum hormone levels within a natural cycle frozen embryo transfer protocol.
The hypothesis is that home urinary monitoring can reliably detect the LH surge and serve as a trigger for timing the FET. Results of this study may ultimately lead to change in clinical practice by reducing the number of clinic visits for serum monitoring, offering a more convenient, time and cost saving method of detection of LH surge. If the proposed protocol were feasible and widely accepted by patients, this would prompt the wide adoption of a less invasive but equally as effective FET protocol.
Read the detailed description
A prospective multi-center cohort study evaluating the anticipated utility of the Mira device for detection of the LH surge, in natural cycle frozen embryo transfer protocols. All patients scheduled for undergoing natural cycle frozen embryo transfers at The Ottawa Fertility Centre (Ottawa, Ontario, Canada) and Olive Fertility Centre (Vancouver, British Columbia, Canada) with the ability to provide informed consent for participation will be eligible for inclusion. Each individual patient may only be included once in the study.
The objective of the proposed study is to evaluate whether the use of home urinary testing of quantitative estradiol metabolites and LH can be used to accurately predict ovulation and serve as a trigger for the gold standard of serum LH monitoring in a natural cycle protocol for frozen embryo transfer (FET). Its anticipated that this at home device will provide a reliable alternative to daily bloodwork, thereby reducing the number of daily visits for serum monitoring and also increased satisfaction and quality of life with the implementation of their use within these cycles.
Estrone glucuronide (E3G) and Pregnanediol-3-Glucoronide (PdG) are the major metabolites of estradiol (E2) and progesterone that can be measured in the urine. Similarly, LH is another hormone that is commonly measured during natural cycle FET cycles and can also be quantified in the urine. Urinary E3G, LH and PdG measurement are commercially available with an FDA and CE registered home device called the Mira Fertility Tracker ("Mira"). Correlation between the serum hormones and their respective urinary metabolites has been established but the efficacy of monitoring urinary E3G and LH has not been demonstrated in the context of natural cycle FET.
Therefore the study will take place within a true natural cycle protocol, whereby ovulation occurs spontaneously and is not triggered with exogenous hormones. Patients meet to discuss the approach to FET with their physician prior to proceeding with treatment. Patients are considered to be candidates for natural cycle protocol if they have regular menstrual cycles, ranging in length between 27-35 days and no luteal phase concern (i.e. significant luteal phase spotting, or evidence of a short luteal phase).
- Conditions
- Fertility Issues
- Being tested
- MIRA Device
- Keywords
- Mira device, Fertility tracking, At home use
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIRA DeviceDevice
Also called Device wands
At home diagnostic testing
| Study group | Role | What they receive |
|---|---|---|
| Single Cohort Group | Evaluating the anticipated utility of the Mira device for detection of the LH surge, in natural cycle frozen embryo transfer protocols Receives: Device: MIRA Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
average delay in days
delay in days of surge detection between the Mira device compared to the serum detection, corrected for the time of the tests.
Measured: Through study completion, an average of 1 year
Patient satisfaction Survey
evaluate patient satisfaction with the use of the Mira device and willingness to utilize this device as an alternative to daily serum monitoring
Measured: Through study completion, an average of 1 year
Secondary outcomes (2)
Progesterone metabolites
Evaluate the proportion of cycles that have a rise in PdG (a urinary progesterone metabolite) prior to or at the time of their LH surge
Measured: Through study completion, an average of 1 year
BhCG urine vs Blood
evaluate the correlation of urinary BhCG measurements relative to serum BhCG evaluation 12-14 days post embryo transfer.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study startJun 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Fertility Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Quanovate Tech Inc.
- Responsible party
- Principal investigator, Dr. Jenna Gale, Ottawa Fertility Centre
- Investigators
- Jenna Gale, MD, Principal investigator, Ottawa Fertility Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410170
- Sponsor's protocol ID
- 2024-3364-17398-2
- Acronym
- MIRA
- Status last verified
- Jun 2024
- First submitted
- 25 Apr 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Urinary and Serum Hormone Levels in Natural Cycle Frozen Embryo Transfer Cycles
- ClinicalTrials.gov ID
- NCT06410170
- Acronym / sponsor ID
- MIRA / 2024-3364-17398-2
- Conditions
- Fertility Issues
- Keywords
- Mira device, Fertility tracking, At home use
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ottawa Fertility CentreUniversity, hospital or other
- Collaborators
- Quanovate Tech Inc.
- Study start
- Jun 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 May 2024 (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.
To evaluate whether the measurement of urinary estrone glucuronide and luteinizing hormone (LH) concentrations with an at-home device is correlated with serum hormone levels within a natural cycle frozen embryo transfer protocol.
The hypothesis is that home urinary monitoring can reliably detect the LH surge and serve as a trigger for timing the FET. Results of this study may ultimately lead to change in clinical practice by reducing the number of clinic visits for serum monitoring, offering a more convenient, time and cost saving method of detection of LH surge. If the proposed protocol were feasible and widely accepted by patients, this would prompt the wide adoption of a less invasive but equally as effective FET protocol.
Detailed description
A prospective multi-center cohort study evaluating the anticipated utility of the Mira device for detection of the LH surge, in natural cycle frozen embryo transfer protocols. All patients scheduled for undergoing natural cycle frozen embryo transfers at The Ottawa Fertility Centre (Ottawa, Ontario, Canada) and Olive Fertility Centre (Vancouver, British Columbia, Canada) with the ability to provide informed consent for participation will be eligible for inclusion. Each individual patient may only be included once in the study.
The objective of the proposed study is to evaluate whether the use of home urinary testing of quantitative estradiol metabolites and LH can be used to accurately predict ovulation and serve as a trigger for the gold standard of serum LH monitoring in a natural cycle protocol for frozen embryo transfer (FET). Its anticipated that this at home device will provide a reliable alternative to daily bloodwork, thereby reducing the number of daily visits for serum monitoring and also increased satisfaction and quality of life with the implementation of their use within these cycles.
Estrone glucuronide (E3G) and Pregnanediol-3-Glucoronide (PdG) are the major metabolites of estradiol (E2) and progesterone that can be measured in the urine. Similarly, LH is another hormone that is commonly measured during natural cycle FET cycles and can also be quantified in the urine. Urinary E3G, LH and PdG measurement are commercially available with an FDA and CE registered home device called the Mira Fertility Tracker ("Mira"). Correlation between the serum hormones and their respective urinary metabolites has been established but the efficacy of monitoring urinary E3G and LH has not been demonstrated in the context of natural cycle FET.
Therefore the study will take place within a true natural cycle protocol, whereby ovulation occurs spontaneously and is not triggered with exogenous hormones. Patients meet to discuss the approach to FET with their physician prior to proceeding with treatment. Patients are considered to be candidates for natural cycle protocol if they have regular menstrual cycles, ranging in length between 27-35 days and no luteal phase concern (i.e. significant luteal phase spotting, or evidence of a short luteal phase).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Cohort Group | – | Device: MIRA DeviceEvaluating the anticipated utility of the Mira device for detection of the LH surge, in natural cycle frozen embryo transfer protocols |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants that are presenting for a natural cycle frozen embryo transfer at The Ottawa and Olive Fertility Centre's
Key inclusion criteria (2 listed)
- All patients scheduled for a natural cycle frozen embryo transfer
- Agree to participate in the research study
Key exclusion criteria (1 listed)
- There are no exclusions
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 |
|---|---|---|
| MIRA DeviceAlso: Device wandsAt home diagnostic testing | Device | Single Cohort Group |
Primary outcome
average delay in days
Time frame: Through study completion, an average of 1 year
delay in days of surge detection between the Mira device compared to the serum detection, corrected for the time of the tests.
Patient satisfaction Survey
Time frame: Through study completion, an average of 1 year
evaluate patient satisfaction with the use of the Mira device and willingness to utilize this device as an alternative to daily serum monitoring
2 secondary outcomes
Progesterone metabolites
Time frame: Through study completion, an average of 1 year
BhCG urine vs Blood
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
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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.
Jenna Gale, MD principal investigator
Ottawa Fertility Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Issues, run by Ottawa Fertility Centre at 1 site in Canada.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Jun 2024. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer McDowall (613-686-3378 ext. 620, jmcdowall@conceive.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
average delay in days (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 10 Jun 2024.