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Clearblue Connected Ovulation Test System (COTS) has been designed for home use by women who are either planning or trying for a pregnancy. This study will determine the difference in pregnancy rate of female volunteers seeking to get pregnant who use COTS in comparison to those not using an ovulation product to assist with conception.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COTS | Active Comparator | Volunteers will be provided with Clearblue connected Ovulation test system to use during the study period, accortding to the instructions for use. |
|
| Control | No Intervention | Volunteers will not be provided with Clearblue Connected Ovulation Test System and will be instructed not to use any other ovulation predictions tests during the study period. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clearblue Connected Ovulation Test System | Device | Urinary LH test to predict ovulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in pregnancy rates across 2 cycles of use between volunteers trying to conceive in the home setting using (i) COTS, (ii) no intervention. | The difference in pregnancy rates between volunteers trying to conceive in the home setting using (i) COTS (ii) no intervention | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of behaviour of women trying to conceive | Quantitative assessment in methods used to try and help with conception and intercourse patterns. | 2 months |
| Evaluation of women's experience of trying to conceive using COTS compared to not using ovulation tests |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Johnson, Dr | SPD Development Company Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPD Development Company Ltd | Bedford | Bedfordshire | MK44 3UP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35136878 | Derived | Johnson S, Bond S, Grace B, Marriott L. Increased Chance of Live Birth Following Use of Connected Ovulation Test System: Outcome Results from a Randomized Controlled Trial. Womens Health Rep (New Rochelle). 2022 Jan 31;3(1):60-66. doi: 10.1089/whr.2021.0102. eCollection 2022. |
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Qualitative interview responses regarding usage and experience of COTS or other methods whilst trying to conceive. |
| 2 months |