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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kegg | Device | Fertility status monitor |
|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Women who meet the eligibility criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lady Technologies Inc | San Francisco | California | 94107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38705979 | Background | 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. |
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