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Approximately 150 female volunteers wishing to become pregnant will be recruited via web recruitment from around the UK and randomised 1:1 to receive Clearblue Digital ovulation tests (active arm) or no aid to conception (control arm) for 2 full menstrual cycles. All volunteers will complete study questionnaires and provide a urine sample at designated time points though out the menstrual cycle.
A sub-arm to this study, applied the same protocol to women in an infertility treatment setting; Royal Hallamshire Hospital, Sheffield. Additional exclusion criteria were applied to this cohort; had regular menstrual cycles between 25 and 35 days, and who did not have a diagnosis of bilateral or unilateral tubal blockage, documented anovulation or severe male-factor infertility (with <5 million motile sperm per ejaculate). For this arm, the protocol was reviewed by Sheffield Research Ethics Committee 09/H1308/134.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Use of ovulation tests to aid conception | ||
| Control | No ovulation tests to aid conception |
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| Measure | Description | Time Frame |
|---|---|---|
| Cortisol Measurement | Measurement of Urinary Cortisol throughout menstrual cycle | Twice monthly |
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Inclusion Criteria:
Exclusion Criteria:
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Females aged 18 to 40 wishing to become pregnant
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Johnson, Dr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPD Development Company Ltd | Bedford | Bedfordshire | MK44 3UP | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26689590 | Derived | Jones G, Carlton J, Weddell S, Johnson S, Ledger WL. Women's experiences of ovulation testing: a qualitative analysis. Reprod Health. 2015 Dec 21;12:116. doi: 10.1186/s12978-015-0103-y. | |
| 23081872 | Derived | Tiplady S, Jones G, Campbell M, Johnson S, Ledger W. Home ovulation tests and stress in women trying to conceive: a randomized controlled trial. Hum Reprod. 2013 Jan;28(1):138-51. doi: 10.1093/humrep/des372. Epub 2012 Oct 18. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 7, 2017 | |
| Unrelease | Yes | |
| Release | Apr 18, 2017 | |
| Reset | Jul 3, 2017 | |
| Release | Feb 14, 2018 | |
| Reset | Oct 29, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 7, 2017 | Yes | |||
| Apr 18, 2017 |
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Urine samples
| Jul 3, 2017 |
| Feb 14, 2018 | Oct 29, 2018 |