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Reproductive Life Plan-based Counseling With Men

Reproductive Life Plan-based Counseling With Men

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02736214
Enrollment
229
Registered
2016-04-13
Start date
2014-10-31
Completion date
2016-04-25
Last updated
2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fertility, Gender Role, Lifestyle, Pregnancy, Sexual Behavior

Brief summary

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.

Interventions

BEHAVIORALReproductive Life Plan (RLP)

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

Sponsors

Uppsala University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Masking description

The randomization was blind to the participants, but they were made aware of their allocation during the intervention

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Non-Swedish speaking * Female gender identity

Design outcomes

Primary

MeasureTime frameDescription
Knowledge of reproduction, measured by a total knowledge score2-3 months after the interventionKnowledge 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
Knowledge of lifestyle related factors that can affect fertility, measured by the total number of factors mentioned2-3 months after the interventionThe 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

MeasureTime frameDescription
Generating new thoughts (Likert-scale)2-3 months after the interventionIf 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)
Generating further knowledge seeking (Likert-scale)2-3 months after the interventionIf 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)
Implications for future health care seeking (Likert-scale)2-3 months after the interventionWhether 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)
Overall experiences of the intervention (Likert-scale)2-3 months after the interventionExperience of the intervention is measured on a Likert-scale by the question of \- The participants overall experience of the intervention (very positive - very negative)
Likelihood of future lifestyle change (Likert-scale)2-3 months after the interventionWhether 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)
Importance of discussing fertility and preconception health with men (Likert-scale)2-3 months after the interventionThe 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)
Implications for implementing RLP-counseling as a routine (yes/no)2-3 months after the interventionThe 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)
Experience of discussing reproductive life plan (RLP) with a midwife (Likert-scale)2-3 months after the interventionExperience 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)

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026