Kegg Fertility Study

NCT06862440 | Active Not Recruiting FDA Device

• 1 other identifier: LT-002
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.evaluate the association between Kegg electrical impedance readings and cervical mucus observations with regard to determining fertility status; and
2. 2.compare the accuracy of Kegg electrical impedance readings with hormone urine strips in identifying the complete fertile window determined by cervical mucus observations.

Conditions

Fertility

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

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

Interventions

Kegg DEVICE

Fertility status monitor

Kegg Cohort

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women who meet the eligibility criteria

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lady Technologies Inc: lead

Study Sites (1)

Lady Technologies Inc

San Francisco, California, 94107, United States

Location

Related Publications (1)

• 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.

  PMID: 38705979 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: March 6, 2025
• Study Start: January 9, 2025
• Primary Completion (Estimated): June 9, 2027
• Study Completion (Estimated): July 9, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)