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

NCT06410170 | Not Yet Recruiting FDA Device

• 1 other identifier: 2024-3364-17398-2
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fertility Issues

Keywords

Mira device; Fertility tracking; At home use

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Progesterone metabolites

  Through study completion, an average of 1 year

• BhCG urine vs Blood

  Through study completion, an average of 1 year

Study Arms (1)

Single Cohort Group

Evaluating the anticipated utility of the Mira device for detection of the LH surge, in natural cycle frozen embryo transfer protocols

Device: MIRA Device

Interventions

MIRA Device DEVICE

At home diagnostic testing

Also known as: Device wands

Single Cohort Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All patients scheduled for a natural cycle frozen embryo transfer
• Agree to participate in the research study

Sponsors & Collaborators

• Ottawa Fertility Centre: lead
• Quanovate Tech Inc.: collaborator

Study Sites (1)

Olive Fertility Centre

Vancouver, British Columbia, V5Z 3X7, Canada

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Jenna Gale, MD

  Ottawa Fertility Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer McDowall

CONTACT

613-686-3378; jmcdowall@conceive.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 13, 2024
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: June 10, 2024

Record last verified: 2024-06

Locations

CA (1)