Quantum Natural Family Planning Pilot (QNFP)

Quanovate Tech

Status: Completed

Conditions: Fertility Disorders

Treatments: Device: Mira monitor comparison to ClearBlue monitor

Study type: Interventional

Funder types: Industry

Identifiers

NCT03908697

HREBA.CTC-19-0046

Details and patient eligibility

About

•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.

Full description

• 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

Enrollment: 26 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Single cohort

Experimental group

Description:

All 20 participants will use ClearBlue and Mira monitors on first morning urine

Treatment:

Device: Mira monitor comparison to ClearBlue monitor