ConceptionSEXTACTICNCT02814006
Sexual Timing in Couples Actively Trying to Conceive
A study testing health educational video in people with Conception, run by Universidade do Porto at 1 site in Portugal.
Trial summary
This study will asses the effectiveness of two strategies for timed intercourse in couples actively trying to conceive Read more about this study
- Who is it for?
- Ages 24 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Conception
- What is being tested?
- health educational video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 sitePortugal
- Study dates
- Oct 2016to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Childless couples trying to conceive
- Relationship length > one year
Who cannot join
- Couples that already had achieved a successful pregnancy
- Couples with children
Trial locations and contacts
1 site in 1 country.
Portugal1 site
University of Porto, Faculty of Psychology and Educational and Education Sciences
Porto, 4200-193
About this study
Official title: What is the Best Sexual Intercourse Strategy for Couples Actively Trying to Conceive?
This study will asses the effectiveness of two strategies for timed intercourse in couples actively trying to conceive
- Conditions
- Conception
- Being tested
- health educational video
- Keywords
- marital relationship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health educational videoOther
visualization of health educational video
| Study group | Role | What they receive |
|---|---|---|
| every other day | Experimental | participants will visualize educational video with timed intercourse as recommended by NICE and ASRM Receives: Other: health educational video |
| fertile window | Experimental | participants will visualize educational video with timed intercourse as recommended by well-know evidence of better conception rates when using this strategy Receives: Other: health educational video |
| CG | No intervention | participants will respond to questionnaire with no knowledge of intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sexual functioning over the course of one year
Self-report measure (FSFI, Rosen et al., 2000; IIEF, Rosen et al., 1997)
Measured: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
Secondary outcomes (5)
Change in Depression over the course of one year
Self-report measure (HADS, \& Snaith Zigmund, 1994)
Measured: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
Change in Anxiety over the course of one year
Self-report measure (HADS, \& Snaith Zigmund, 1994)
Measured: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
Number of participants that attain an infertility diagnosis
Measured: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
Number of participants that achieve conception
Measured: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
Change in social support over the course of one year
Self-report measure (2WSS, Shakespeare-finch \& Obst, 2011)
Measured: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Sponsor
- Investigators
- Mariana V Martins, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02814006
- Sponsor's protocol ID
- FPCEUP/RH3
- Acronym
- SEXTACTIC
- Status last verified
- Mar 2020
- First submitted
- 17 Jun 2016
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Martins MV, Fernandes J, Pedro J, Barros A, Xavier P, Schmidt L, Costa ME. Effects of trying to conceive using an every-other-day strategy versus fertile window monitoring on stress: a 12-month randomized controlled trial. Hum Reprod. 2022 Nov 24;37(12):2845-2855. doi: 10.1093/humrep/deac228.
PubMed 36272105
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What is the Best Sexual Intercourse Strategy for Couples Actively Trying to Conceive?
- ClinicalTrials.gov ID
- NCT02814006
- Acronym / sponsor ID
- SEXTACTIC / FPCEUP/RH3
- Conditions
- Conception
- Keywords
- marital relationship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- Oct 2016
- Primary completion
- Oct 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will asses the effectiveness of two strategies for timed intercourse in couples actively trying to conceive
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| every other day | Experimental | Other: health educational videoparticipants will visualize educational video with timed intercourse as recommended by NICE and ASRM |
| fertile window | Experimental | Other: health educational videoparticipants will visualize educational video with timed intercourse as recommended by well-know evidence of better conception rates when using this strategy |
| CG | No intervention | –participants will respond to questionnaire with no knowledge of intervention |
Who may qualify
- Ages
- 24 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Childless couples trying to conceive
- Relationship length > one year
Key exclusion criteria (2 listed)
- Couples that already had achieved a successful pregnancy
- Couples with children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| health educational videovisualization of health educational video | Other | every other day, fertile window |
Primary outcome
Change in sexual functioning over the course of one year
Time frame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
Self-report measure (FSFI, Rosen et al., 2000; IIEF, Rosen et al., 1997)
5 secondary outcomes
Change in Depression over the course of one year
Time frame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
Change in Anxiety over the course of one year
Time frame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
Number of participants that attain an infertility diagnosis
Time frame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
Number of participants that achieve conception
Time frame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
Change in social support over the course of one year
Time frame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- Derived from this study: PubMed 36272105Martins MV, Fernandes J, Pedro J, Barros A, Xavier P, Schmidt L, Costa ME. Effects of trying to conceive using an every-other-day strategy versus fertile window monitoring on stress: a 12-month randomized controlled trial. Hum Reprod. 2022 Nov 24;37(12):2845-2855. doi: 10.1093/humrep/deac228.
- Individual participant dataSharing planned: Undecided
Related trials for Conception
Active, not recruitingObservational study
Factors Influencing Fertility or Pregnancy Health
Menstrual Cycles, Conception
Not yet recruitingObservational study
Predictors of Successful Office Operative Hysteroscopy Using a Mini-Resectoscope
Retained Products of Conception, Hysteroscopy
RecruitingPhase 4
Intracervical Vasopressin
Retained Products of Conception
Recruiting
Removal of Intrauterine Retained Products of Conception (RPOC) After Miscarriage Guided by Hysteroscopy Trial. A Randomized Controlled Trial.
Retained Products of Conception
Recruiting
Success Rates of Expectant vs. Medical Management for Retained Products After First-Trimester Abortion: Randomized Controlled Trial
Retained Product of Conception After First Trimester Medical Abortion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana V Martins, PhD principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health educational video in people with Conception, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sexual functioning over the course of one year (time frame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02814006, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2021; AzTrials last refreshed its copy on 30 Oct 2026.