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Active, Not Recruiting

NCT Number: NCT06862440

Kegg Fertility Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Lady Technologies Inc

San Francisco, California, 94107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Participant is unable to read and understand English
  • Postmenopausal women
  • Women with hysterectomy
  • Pregnancy
  • 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

Treatment and study plan

Kegg

Device

Fertility status monitor

Primary outcomes

  1. Mucus characteristics quantified by electrical impedance readings

    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.

  2. Cervical mucus scores

    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

  3. Urine hormone test results

    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

Sponsors and collaborators

Lead sponsor

Lady Technologies Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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