Quantum Natural Family Planning Pilot

Fertility Disorders Clinical Trial

— QNFP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03908697
• Other study ID #: HREBA.CTC-19-0046
• Status: Completed
• Phase: N/A
• Start date: May 29, 2020
• Est. completion date: April 22, 2021

Study information

• Verified date: June 2021
• Source: Quanovate Tech Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

•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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 22, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Disorders

Intervention

Device:
• Mira monitor comparison to ClearBlue monitor
Testing first morning urine with hormone test sticks at home

Locations

Country	Name	City	State
Canada	Deer Valley family Medicine Clinic	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Quanovate Tech Inc.

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Bouchard TP, Fehring RJ, Schneider MM. Achieving Pregnancy Using Primary Care Interventions to Identify the Fertile Window. Front Med (Lausanne). 2018 Jan 9;4:250. doi: 10.3389/fmed.2017.00250. eCollection 2017. — View Citation

Direito A, Bailly S, Mariani A, Ecochard R. Relationships between the luteinizing hormone surge and other characteristics of the menstrual cycle in normally ovulating women. Fertil Steril. 2013 Jan;99(1):279-285.e3. doi: 10.1016/j.fertnstert.2012.08.047. — View Citation

Ecochard R, Bouchard T, Leiva R, Abdulla S, Dupuis O, Duterque O, Garmier Billard M, Boehringer H, Genolini C. Characterization of hormonal profiles during the luteal phase in regularly menstruating women. Fertil Steril. 2017 Jul;108(1):175-182.e1. doi: 1 — View Citation

Leiva RA, Bouchard TP, Abdullah SH, Ecochard R. Urinary Luteinizing Hormone Tests: Which Concentration Threshold Best Predicts Ovulation? Front Public Health. 2017 Nov 28;5:320. doi: 10.3389/fpubh.2017.00320. eCollection 2017. Erratum in: Front Public Hea — View Citation

Severy LJ, Robinson J, Findley-Klein C, McNulty J. Acceptability of a home monitor used to aid in conception: psychosocial factors and couple dynamics. Contraception. 2006 Jan;73(1):65-71. Epub 2005 Sep 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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

External Links

•   Official product website