Detection of Fertile Window and Ovulation With At-Home Kegg Fertility Monitor: A Comparative Study With Standardized Cervical Mucus Observations and Urine Hormone Measurements
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- Mucus characteristics quantified by electrical impedance readings
研究概览
简要总结
Fertility Awareness Based Methods (FABMs), such as calendar tracking, basal body temperature (BBT), and monitoring cervical mucus, are widely used but may have limitations in accurately detecting the complete fertility window. Serum hormone measurements and transvaginal ultrasound are more accurate at determining time of ovulation and fertile window, but are costly and inconvenient. Urine-based luteinizing hormone (LH) tests offer improvement. However, LH surge typically occurs 24 to 36 hours prior to ovulation, only capturing the later portion of the fertile window.
A novel approach involves using electrical impedance to track compositional changes in cervical mucus, providing real-time, at-home data. The Kegg device (Lady Technologies Inc, San Francisco, CA, USA) is an intravaginal device that measures cervical mucus impedance to monitor fertility status. Previous studies show it has higher sensitivity, specificity, and accuracy compared to BBT alone in determining the ovulation window. This method offers a cost-effective and practical alternative for at-home fertility tracking.
The objectives of this study are to:
- evaluate the association between Kegg electrical impedance readings and cervical mucus observations with regard to determining fertility status; and
- compare the accuracy of Kegg electrical impedance readings with hormone urine strips in identifying the complete fertile window determined by cervical mucus observations.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Biological female
- •Age between 18-40 years old
- •Participant has provided signed informed consent
- •Completed cervical mucus observation training
- •Owns and uses daily a smart device meeting the following requirement: Apple iPad or iPhone running iOS 13 or newer, or Apple Watch running WatchOS 6.0 or newer, or Android operating system of 6.0 or newer
- •Has readily accessible internet
- •Legal residents of the continental United States, excluding Alaska and Hawaii.
排除标准
- •Participant is unable to read and understand English
- •Postmenopausal women
- •Women with hysterectomy
- •Hormonal or intrauterine contraceptives or other hormone use prior to start of study enrollment [No oral hormonal contraceptives or other hormones for at least one month, no implantable contraceptives or hormonal or non-hormonal intrauterine device for at least two months (~2 cycles), no injectable hormonal contraceptives or other hormones in past 9 months from the most recent injection and resumption of regular menstrual cycles
研究组 & 干预措施
Kegg Cohort
Daily data collection of kegg electrical impedance, urine hormone test, and basal body temperature on non-bleeding days. Data will be collected for 3 cycles.
干预措施: Kegg (Device)
结局指标
主要结局
Mucus characteristics quantified by electrical impedance readings
时间窗: Daily on non-bleeding days for 3 cycles (each cycle is approximately 28 days)
Electrical impedance measured daily on non-bleeding days for 3 menstrual cycles.
Cervical mucus scores
时间窗: Daily on non-bleeding days for 3 cycles (each cycle is approximately 28 days)
Participant self-graded scores of cervical mucus appearance using standardized scoring system
Urine hormone test results
时间窗: Daily on non-bleeding days for 3 cycles (each cycle is approximately 28 days)
Hormone changes in E1G (estrogen), LH, luteinizing hormone, and PdG (progesterone) measured by urine hormone test
次要结局
未报告次要终点
研究者
Jan Rydfords
Principal Investigator
Lady Technologies Inc