RECRUITING

Kegg Fertility Study

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-01-09
Study Completion:2027-07-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06862440

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Biological female
  2. 2. Age between 18-40 years old
  3. 3. Participant has provided signed informed consent
  4. 4. Completed cervical mucus observation training
  5. 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. 6. Has readily accessible internet
  7. 7. Legal residents of the continental United States, excluding Alaska and Hawaii.
  1. 1. Participant is unable to read and understand English
  2. 2. Postmenopausal women
  3. 3. Women with hysterectomy
  4. 4. Pregnancy
  5. 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

Contacts and Locations

Study Contact

The Kegg Fertility Study Team
CONTACT
628-500-9161
clinicalresearch@kegg.tech

Study Locations (Sites)

Lady Technologies Inc
San Francisco, California, 94107
United States

Collaborators and Investigators

Sponsor: Lady Technologies Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-09
Study Completion Date2027-07-09

Study Record Updates

Study Start Date2025-01-09
Study Completion Date2027-07-09

Terms related to this study

Additional Relevant MeSH Terms

  • Fertility