Quantum Natural Family Planning Pilot

NCT03908697 | Completed

• 1 other identifier: HREBA.CTC-19-0046
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fertility Disorders

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Satisfaction and Ease of Use of a Electronic Fertility Monitor:

  3 months

Study Arms (1)

Single cohort

EXPERIMENTAL

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

Device: Mira monitor comparison to ClearBlue monitor

Interventions

Mira monitor comparison to ClearBlue monitor DEVICE

Testing first morning urine with hormone test sticks at home

Single cohort

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Menstrual cycle ranging between 21-42 days
• At least 3 cycles after cessation of breastfeeding

You may not qualify if:

• 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

Sponsors & Collaborators

• Quanovate Tech Inc.: lead

Study Sites (1)

Deer Valley family Medicine Clinic

Calgary, Alberta, T2J6W5, Canada

Location

Related 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.

  PMID: 29376054 BACKGROUND

• 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: 10.1016/j.fertnstert.2017.05.012. Epub 2017 Jun 1.

  PMID: 28579410 BACKGROUND

• 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.

  PMID: 29234665 BACKGROUND

• 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. Epub 2012 Sep 19.

  PMID: 22999798 BACKGROUND

• 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. doi: 10.1016/j.contraception.2005.07.008. Epub 2005 Sep 19.

  PMID: 16371298 BACKGROUND

Related Links

• Official product website

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Anonymized demographic data
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer

Model Details: 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.

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 9, 2019
• Study Start: May 29, 2020
• Primary Completion: February 28, 2021
• Study Completion: April 22, 2021
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)