Correlation of Urinary and Serum Hormone Levels in Natural Cycle Frozen Embryo Transfer Cycles
NCT ID: NCT06410170
Last Updated: 2024-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2024-06-30
2025-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Single Cohort Group
Evaluating the anticipated utility of the Mira device for detection of the LH surge, in natural cycle frozen embryo transfer protocols
MIRA Device
At home diagnostic testing
Interventions
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MIRA Device
At home diagnostic testing
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Agree to participate in the research study
Exclusion Criteria
FEMALE
Yes
Sponsors
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Quanovate Tech Inc.
INDUSTRY
Ottawa Fertility Centre
OTHER
Responsible Party
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Dr. Jenna Gale
Research Director
Principal Investigators
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Jenna Gale, MD
Role: PRINCIPAL_INVESTIGATOR
Ottawa Fertility Centre
Locations
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Olive Fertility Centre
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Gary Nakhuda, MD
Role: primary
Other Identifiers
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2024-3364-17398-2
Identifier Type: -
Identifier Source: org_study_id
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