Sexual Timing in Couples Actively Trying to Conceive (SEXTACTIC)

January 8, 2021 updated by: Universidade do Porto

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

244

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal, 4200-193
        • University of Porto, Faculty of Psychology and Educational and Education Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

24 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: every other day
participants will visualize educational video with timed intercourse as recommended by NICE and ASRM
Other: health educational video
visualization of health educational video
Experimental: fertile window
participants will visualize educational video with timed intercourse as recommended by well-know evidence of better conception rates when using this strategy
Other: health educational video
visualization of health educational video
No Intervention: CG
participants will respond to questionnaire with no knowledge of intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
Self-report measure (HADS, & Snaith Zigmund, 1994)
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]
Self-report measure (HADS, & Snaith Zigmund, 1994)
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]
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]
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]
Self-report measure (2WSS, Shakespeare-finch & Obst, 2011)
T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Collaborators

Fundação para a Ciência e a Tecnologia

Investigators

  • Principal Investigator: Mariana V Martins, PhD, Universidade do Porto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

October 1, 2020

Study Completion (Actual)

October 1, 2020

Study Registration Dates

First Submitted

June 17, 2016

First Submitted That Met QC Criteria

June 24, 2016

First Posted (Estimate)

June 27, 2016

Study Record Updates

Last Update Posted (Actual)

January 11, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FPCEUP/RH3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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