FertilityCMTrak-USNCT06862440
Kegg Fertility Study
An observational study of Fertility, run by Lady Technologies Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility
- What is being tested?
- Kegg
- Type of treatment
- Medical device
- How many people
- 189 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2025to 7 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women who meet the eligibility criteria
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Lady Technologies Inc
San Francisco, California, 94107
About this study
Official 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
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.
Read more
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.
- Conditions
- Fertility
- Being tested
- Kegg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeggDevice
Fertility status monitor
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Kegg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mucus characteristics quantified by electrical impedance readings
Electrical impedance measured daily on non-bleeding days for 3 menstrual cycles.
Measured: 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
Measured: 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
Measured: Daily on non-bleeding days for 3 cycles (each cycle is approximately 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start9 Jan 2025
- Primary completion7 Sep 2026
- Study completion7 Sep 2026
Why it stopped: sponsor funding issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lady Technologies Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Jan Rydfords, Lady Technologies Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862440
- Sponsor's protocol ID
- LT-002
- Acronym
- CMTrak-US
- Status last verified
- Sep 2026
- First submitted
- 23 Jan 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 38705979
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06862440
- Acronym / sponsor ID
- CMTrak-US / LT-002
- Conditions
- Fertility
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: sponsor funding issue
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Lady Technologies IncIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 7 Sep 2026 (actual)
- Study completion
- 7 Sep 2026 (actual)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kegg Cohort | – | Device: KeggDaily data collection of kegg electrical impedance, urine hormone test, and basal body temperature on non-bleeding days. Data will be collected for 3 cycles. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women who meet the eligibility criteria
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KeggFertility status monitor | Device | Kegg Cohort |
Primary outcome
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.
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
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
Results and safety
The study was stopped early (reason given: sponsor funding issue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 38705979Tabbaa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility, run by Lady Technologies Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: sponsor funding issue). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucus characteristics quantified by electrical impedance readings (time frame: Daily on non-bleeding days for 3 cycles (each cycle is approximately 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06862440, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.