Lady Technologies Inc
San Francisco, California, 94107, United States
NCT Number: NCT06862440
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:
1. evaluate the association between Kegg electrical impedance readings and cervical mucus observations with regard to determining fertility status; and 2. compare the accuracy of Kegg electrical impedance readings with hormone urine strips in identifying the complete fertile window determined by cervical mucus observations.
This study is active but is not currently recruiting participants.
18 year–40 year
Female
Observational
San Francisco, California, 94107, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fertility status monitor
Time frame: 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.
Time frame: 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
Time frame: 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
Lady Technologies Inc
Industry
Detection of Fertile Window and Ovulation With At-Home Kegg Fertility Monitor: A Comparative Study With Standardized Cervical Mucus Observations and Urine Hormone Measurements
Acronym: CMTrak-US
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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