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临床试验/NCT03908697
NCT03908697已完成不适用

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

Quanovate Tech Inc.2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年5月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
Day of the estimated beginning of the fertile phase of the menstrual cycle:

研究概览

简要总结

•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.

详细描述

  • 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

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

盲法说明

Anonymized demographic data

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • • 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

结局指标

主要结局

Day of the estimated beginning of the fertile phase of the menstrual cycle:

时间窗: 3 months

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

Day of the estimated peak of the fertile phase of the menstrual cycle:

时间窗: 3 months

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

Day of the estimated end of the fertile phase of the menstrual cycle:

时间窗: 3 months

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

次要结局

  • Satisfaction and Ease of Use of a Electronic Fertility Monitor:(3 months)

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Thomas Bouchard, MD

Clinical Lecturer

University of Calgary

研究点 (2)

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