Kegg Fertility Study (CMTrak-US)

Detection of Fertile Window and Ovulation With At-Home Kegg Fertility Monitor: A Comparative Study With Standardized Cervical Mucus Observations and Urine Hormone Measurements

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Fertility
• Intervention / Treatment: Device: Kegg

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94107
      • Lady Technologies Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women who meet the eligibility criteria

Description

Inclusion Criteria:

1. Biological female
2. Age between 18-40 years old
3. Participant has provided signed informed consent
4. Completed cervical mucus observation training
5. 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
6. Has readily accessible internet
7. Legal residents of the continental United States, excluding Alaska and Hawaii.

Exclusion Criteria:

1. Participant is unable to read and understand English
2. Postmenopausal women
3. Women with hysterectomy
4. Pregnancy
5. 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Kegg; Fertility status monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mucus characteristics quantified by electrical impedance readings	Electrical impedance measured daily on non-bleeding days for 3 menstrual cycles.	Daily on non-bleeding days for 3 cycles (each cycle is approximately 28 days)
Cervical mucus scores	Participant self-graded scores of cervical mucus appearance using standardized scoring system	Daily on non-bleeding days for 3 cycles (each cycle is approximately 28 days)
Urine hormone test results	Hormone changes in E1G (estrogen), LH, luteinizing hormone, and PdG (progesterone) measured by urine hormone test	Daily on non-bleeding days for 3 cycles (each cycle is approximately 28 days)

Collaborators and Investigators

• Sponsor: Lady Technologies Inc

Publications and helpful links

General Publications

• Tabbaa S, Hambright S, Sikes KJ, Levy G, Rydfors J. The effectiveness of cervical mucus electrical impedance compared to basal body temperature to determine fertility window. Contracept Reprod Med. 2024 May 6;9(1):20. doi: 10.1186/s40834-024-00276-w.

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2025
• Primary Completion (Estimated): June 9, 2027
• Study Completion (Estimated): July 9, 2027

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: March 1, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: LT-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No