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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02736214
Other study ID # RLP-man-RCT
Secondary ID
Status Completed
Phase N/A
First received April 1, 2016
Last updated May 2, 2017
Start date October 2014
Est. completion date April 25, 2016

Study information

Verified date May 2017
Source Uppsala University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 229
Est. completion date April 25, 2016
Est. primary completion date March 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Non-Swedish speaking

- Female gender identity

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Reproductive Life Plan (RLP)
A structured discussion based on the RLP, including information about reproduction and a brochure with the same information.

Locations

Country Name City State
Sweden The RFSU clinic Stockholm
Sweden Flogsta Mansmottagning Uppsala

Sponsors (1)

Lead Sponsor Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View Citation

Stern J, Larsson M, Kristiansson P, Tydén 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
2-3 months after the intervention
Primary 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
2-3 months after the intervention
Secondary 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)
2-3 months after the intervention
Secondary 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)
2-3 months after the intervention
Secondary 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)
2-3 months after the intervention
Secondary 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)
2-3 months after the intervention
Secondary 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)
2-3 months after the intervention
Secondary 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)
2-3 months after the intervention
Secondary 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)
2-3 months after the intervention
Secondary 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)
2-3 months after the intervention
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