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Sexual BehaviorNCT02736214

Reproductive Life Plan-based Counseling With Men

A study testing Reproductive Life Plan (RLP) in people with Sexual Behavior and Lifestyle, run by Uppsala University at 2 sites in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Sexual Behavior, Lifestyle, Fertility
What is being tested?
Reproductive Life Plan (RLP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
229 participants
Where
2 sitesSweden
Study dates
Oct 2014to 25 Apr 2016
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 18 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

  • Non-Swedish speaking
  • Female gender identity

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

  • The RFSU clinic

    Stockholm, 118 26

  • Flogsta Mansmottagning

    Uppsala, 75272

Other trials in Sweden

About this study

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.

Being tested
Reproductive Life Plan (RLP)
Medical subject headings
Sexual Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reproductive Life Plan (RLP)Behavioural

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

Study groups in NCT02736214
Study groupRoleWhat they receive
Lifestyle counselingExperimentalThe intervention group answered a baseline questionnaire in the waiting room and received the intervention (Reproductive Life Plan) in addition to standard care.
Receives: Behavioral: Reproductive Life Plan (RLP)
Control groupNo interventionThe control group answered a baseline questionnaire in the waiting room and received standard care.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: 2-3 months after the intervention

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

    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

    Measured: 2-3 months after the intervention

Secondary outcomes (8)

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

    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)

    Measured: 2-3 months after the intervention

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

    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)

    Measured: 2-3 months after the intervention

  3. Generating new thoughts (Likert-scale)

    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)

    Measured: 2-3 months after the intervention

  4. Generating further knowledge seeking (Likert-scale)

    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)

    Measured: 2-3 months after the intervention

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

    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)

    Measured: 2-3 months after the intervention

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

    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)

    Measured: 2-3 months after the intervention

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

    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)

    Measured: 2-3 months after the intervention

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

    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)

    Measured: 2-3 months after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2016 (estimated)
  2. Study startOct 2014
  3. Primary completionMar 2016
  4. Study completion25 Apr 2016

Resources

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
Single blind
Who is masked
Participant
Enrolment
229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02736214
Sponsor's protocol ID
RLP-man-RCT
Status last verified
May 2017
First submitted
1 Apr 2016
Last updated
5 May 2017
Results posted
No

Publications

  • Warner JN, Frey KA. The well-man visit: addressing a man's health to optimize pregnancy outcomes. J Am Board Fam Med. 2013 Mar-Apr;26(2):196-202. doi: 10.3122/jabfm.2013.02.120143.

    PubMed 23471934

  • Stern J, Larsson M, Kristiansson P, Tyden T. Introducing reproductive life plan-based information in contraceptive counselling: an RCT. Hum Reprod. 2013 Sep;28(9):2450-61. doi: 10.1093/humrep/det279. Epub 2013 Jul 10.

    PubMed 23842564

  • Frey KA, Navarro SM, Kotelchuck M, Lu MC. The clinical content of preconception care: preconception care for men. Am J Obstet Gynecol. 2008 Dec;199(6 Suppl 2):S389-95. doi: 10.1016/j.ajog.2008.10.024.

    PubMed 19081435

Questions about this trial

What is this clinical trial studying?

A study testing Reproductive Life Plan (RLP) in people with Sexual Behavior and Lifestyle, run by Uppsala University at 2 sites in Sweden.

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 1 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 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. 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?

Knowledge of reproduction, measured by a total knowledge score (time frame: 2-3 months after the intervention). The study lists 2 primary outcomes in all. 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 NCT02736214, which also lists 3 linked publications.

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 5 May 2017.

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