Conception Clinical Trial
— SEXTACTICOfficial title:
What is the Best Sexual Intercourse Strategy for Couples Actively Trying to Conceive?
| NCT number | NCT02814006 |
| Other study ID # | FPCEUP/RH3 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | October 2016 |
| Est. completion date | October 2020 |
| Verified date | March 2020 |
| Source | Universidade do Porto |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will asses the effectiveness of two strategies for timed intercourse in couples actively trying to conceive
| Status | Completed |
| Enrollment | 244 |
| Est. completion date | October 2020 |
| Est. primary completion date | October 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 24 Years to 40 Years |
| Eligibility | Note: age limits are for female age only Inclusion Criteria: - Childless couples trying to conceive - Relationship length > one year Exclusion Criteria: - Couples that already had achieved a successful pregnancy - Couples with children |
| Country | Name | City | State |
|---|---|---|---|
| Portugal | University of Porto, Faculty of Psychology and Educational and Education Sciences | Porto |
| Lead Sponsor | Collaborator |
|---|---|
| Universidade do Porto | Fundação para a Ciência e a Tecnologia |
Portugal,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in sexual functioning over the course of one year | Self-report measure (FSFI, Rosen et al., 2000; IIEF, Rosen et al., 1997) | T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later] | |
| Secondary | Change in Depression over the course of one year | Self-report measure (HADS, & Snaith Zigmund, 1994) | T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later] | |
| Secondary | Change in Anxiety over the course of one year | Self-report measure (HADS, & Snaith Zigmund, 1994) | T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later] | |
| Secondary | Number of participants that attain an infertility diagnosis | T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later] | ||
| Secondary | Number of participants that achieve conception | T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later] | ||
| Secondary | Change in social support over the course of one year | Self-report measure (2WSS, Shakespeare-finch & Obst, 2011) | T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later] |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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