Skip to main content
OpenTrials
Completed

NCT Number: NCT02736214

Reproductive Life Plan-based Counseling With Men

Many women and men in fertile age are at risk for sexual transmitted infections and unwanted pregnancies, and have insufficient knowledge of health promoting lifestyle prior to conception. There is a need to increase awareness among people in fertile age about how sexual risk-taking and unhealthy lifestyle can negatively affect fertility and pregnancy outcomes. Previous studies on preconception health and care have mainly focused on women. The aim of our study was to investigate if Reproductive Life Plan-based counseling with a midwife could increase men's reproductive knowledge. The second aim was to evaluate men's experiences of the intervention.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sexual Behavior Behavior Fertility Gender Role Lifestyle Pregnancy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The RFSU clinic, Stockholm, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Visitors at drop-in hours at two clinics testing for sexually transmitted infections

Exclusion criteria

  • Non-Swedish speaking
  • Female gender identity

Treatment and study plan

Reproductive Life Plan (RLP)

Behavioral

A structured discussion based on the RLP, including information about reproduction and a brochure with the same information.

Primary outcomes

  1. Knowledge of reproduction, measured by a total knowledge score

    Time frame: 2-3 months after the intervention

    Knowledge of reproduction will be measured by knowledge of the following items:

    • the viability of an ovum
    • the viability of sperm
    • how likely it is that a 25-year old women gets pregnant if she has unprotected intercourse at the time of ovulation
    • at what age there is a marked decline in women's ability to become pregnant
    • the proportion of infertility-cases that are caused by a male factor
    • success rate of IVF-treatment

    The outcome will be given as a total score, based on number of correct answers to the items above, and compared to the total score at baseline

  2. Knowledge of lifestyle related factors that can affect fertility, measured by the total number of factors mentioned

    Time frame: 2-3 months after the intervention

    The participants will be asked to mention as many factors as they can remember that

    • can impair male fertility
    • could be modified in the preconception period to increase the chances of conception and having a healthy offspring

    The number of factors mentioned after the intervention will be compared to the number of factors mentioned at baseline

Secondary outcomes

  1. Overall experiences of the intervention (Likert-scale)

    Time frame: 2-3 months after the intervention

    Experience of the intervention is measured on a Likert-scale by the question of

    • The participants overall experience of the intervention (very positive - very negative)

  2. Experience of discussing reproductive life plan (RLP) with a midwife (Likert-scale)

    Time frame: 2-3 months after the intervention

    Experience of discussing RLP with a midwife is measured on a Likert-scale by the question

    • How was the experience of talking to a midwife about the reproductive life plan (very positive - very negative)

  3. Generating new thoughts (Likert-scale)

    Time frame: 2-3 months after the intervention

    If the intervention could generate new thoughts on reproduction is measured on a Likert-scale by the question

    • Has the intervention brought new thoughts about reproduction (In very large extent - in very small extent)

  4. Generating further knowledge seeking (Likert-scale)

    Time frame: 2-3 months after the intervention

    If the intervention could lead to further knowledge seeking is measured on by the question

    • Did the discussion with the midwife lead to a search for more information about reproduction (A lot more - some more - not at all)

  5. Implications for future health care seeking (Likert-scale)

    Time frame: 2-3 months after the intervention

    Whether the availability of discussing RLP with a midwife would be of future interest is measured on a Likert-scale by the question

    • The likelihood of approaching a midwife if more questions about reproduction occured (Very likely - Very unlikely)

  6. Implications for implementing RLP-counseling as a routine (yes/no)

    Time frame: 2-3 months after the intervention

    The acceptance of implementing RLP-counselling as a routine is measured by the question

    • Should midwives or other health care professionals routinely discuss the Reproductive Life Plan with their patients (yes/no)

  7. Likelihood of future lifestyle change (Likert-scale)

    Time frame: 2-3 months after the intervention

    Whether participants would consider making a preconception lifestyle change is measured on a Likert-scale by the question

    • The likelihood among of making a lifestyle change in the future when planning for a pregnancy (Very likely - Very unlikely)

  8. Importance of discussing fertility and preconception health with men (Likert-scale)

    Time frame: 2-3 months after the intervention

    The perceived significance of RLP-counselling is measured on a Likert-scale by the question

    • The importance of informing/educating men about fertility and preconception health issues (Very important - Very unimportant)

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 13, 2016
Registry last updated
May 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.