Clinical trial NCT03908697: Quantum Natural Family Planning Pilot
Official title: Comparison of Two Hormonal Fertility Monitors for Use in Natural Family Planning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility Disorders
Lead sponsor: Quanovate Tech Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-09
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Day of the estimated beginning of the fertile phase of the menstrual cycle:
timeFrame: 3 months
measure: Day of the estimated peak of the fertile phase of the menstrual cycle:
timeFrame: 3 months
measure: Day of the estimated end of the fertile phase of the menstrual cycle:
timeFrame: 3 months
Secondary outcomes:
measure: Satisfaction and Ease of Use of a Electronic Fertility Monitor:
timeFrame: 3 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Deer Valley family Medicine Clinic
state: Alberta
Study officials:
References:
citation: 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.
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: 10.1016/j.fertnstert.2017.05.012. Epub 2017 Jun 1.
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.
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. Epub 2012 Sep 19.
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. doi: 10.1016/j.contraception.2005.07.008. Epub 2005 Sep 19.