NCT02814006

Brief Summary

This study will asses the effectiveness of two strategies for timed intercourse in couples actively trying to conceive

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

January 11, 2021

Status Verified

March 1, 2020

Enrollment Period

4 years

First QC Date

June 17, 2016

Last Update Submit

January 8, 2021

Conditions

Keywords

marital relationship

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in Depression over the course of one year

    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

    T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]

  • Number of participants that attain an infertility diagnosis

    T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]

  • Number of participants that achieve conception

    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

    T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later]

Study Arms (3)

every other day

EXPERIMENTAL

participants will visualize educational video with timed intercourse as recommended by NICE and ASRM

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

Other: health educational video

CG

NO INTERVENTION

participants will respond to questionnaire with no knowledge of intervention

Interventions

visualization of health educational video

every other dayfertile window

Eligibility Criteria

Age24 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Childless couples trying to conceive
  • Relationship length \> one year

You may not qualify if:

  • Couples that already had achieved a successful pregnancy
  • Couples with children

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Porto, Faculty of Psychology and Educational and Education Sciences

Porto, 4200-193, Portugal

Location

Related Publications (1)

  • 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.

Study Officials

  • Mariana V Martins, PhD

    Universidade do Porto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2016

First Posted

June 27, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

January 11, 2021

Record last verified: 2020-03

Locations