Correlation of Urinary and Serum Hormone Levels in Natural Cycle Frozen Embryo Transfer Cycles

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorOttawa Fertility Centre

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

All patients scheduled for a natural cycle frozen embryo transfer

Agree to participate in the research study

Disqualifiers

There are no exclusions

Trial population

Participants that are presenting for a natural cycle frozen embryo transfer at The Ottawa and Olive Fertility Centre's

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • MIRA Device

    Device

    At home diagnostic testing

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Single Cohort Group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Through study completion, an average of 1 year
2

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

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

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

Time frame
Through study completion, an average of 1 year
2

BhCG urine vs Blood

evaluate the correlation of urinary BhCG measurements relative to serum BhCG evaluation 12-14 days post embryo transfer.

Time frame
Through study completion, an average of 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ottawa Fertility Centre

Lead sponsor

Quanovate Tech Inc.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: