Quantum Natural Family Planning Pilot

Study Overview
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Brief Summary
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•The Pilot study will involve current Marquette Method users who own and use a ClearBlue Fertility monitor and who will be asked to simultaneously use the Mira monitor for the sake of comparing the two devices to monitor the menstrual cycle.

Detailed Description
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The Mira fertility monitoring system (www.miracare.com) is a new home-use hormone tracking device with the ability to quantitatively measure reproductive hormones in the urine but is also synced to a smart phone App that provides a graphic representation of the hormonal levels throughout a menstrual cycle. The Mira monitor will be compared to the ClearBlue Fertility Monitor for its ease of use, satisfaction, and accuracy. The Mira hormonal monitor and App system has not been tested for its use in Natural Family Planning (NFP). The Pilot study will involve current Marquette Method users who own and use a ClearBlue Fertility monitor and who will be asked to simultaneously use the Mira monitor for the sake of comparing the two devices. Female participants invited to participate will need to meet the following criteria: Age 18 to 42 years Menstrual cycle ranging between 21-42 days At least 3 cycles after cessation of breastfeeding Not currently on medications that affect ovulation and 3 months prior Not currently pregnant or breastfeeding No known fertility problems Not planning on achieving pregnancy during the 3 menstrual cycles of the study

Official Title
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Comparison of Two Hormonal Fertility Monitors for Use in Natural Family Planning

Conditions
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Fertility Disorders

Intervention / Treatment
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* Device: Mira monitor comparison to ClearBlue monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Menstrual cycle ranging between 21-42 days At least 3 cycles after cessation of breastfeeding Exclusion Criteria: • Not currently on medications that affect ovulation and 3 months prior Not currently pregnant or breastfeeding No known fertility problems Not planning on achieving pregnancy during the 3 menstrual cycles of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective cohort analysis of three menstrual cycles of hormone data, comparing two fertility monitors that analyze urine hormones. Satisfaction and ease of use will be assessed using surveys. Individual data will be anonymized.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single cohort<br>All 20 participants will use ClearBlue and Mira monitors on first morning urine | Device: Mira monitor comparison to ClearBlue monitor<br>* Testing first morning urine with hormone test sticks at home<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Day of the estimated beginning of the fertile phase of the menstrual cycle: | First day of the estimated fertile phase as measured by Clearblue Fertility Monitor First day of the estimated fertile phase as measured by the MIRA Fertility Monitor | 3 months | 
| Day of the estimated peak of the fertile phase of the menstrual cycle: | Peak day of the estimated fertile phase as measured by the Clearblue Fertility Monitor Peak day of the estimated fertile phase as measured by the MIRA Fertility Monitor | 3 months | 
| Day of the estimated end of the fertile phase of the menstrual cycle: | Last day of the estimated fertile phase as measured by the Clearblue Fertility Monitor Last day of the estimated fertile phase as measured by the MIRA Fertility Monitor | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction and Ease of Use of a Electronic Fertility Monitor: | Measured by the modified 8 item Severy Satisfaction Scale Total score rages from 8 - 24 with 24 being the highest satisfaction | 3 months |