Reproductive Life Plan-based Counseling With Men

Pregnancy Clinical Trial

Official title:

Reproductive Life Plan-based Counseling With Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736214
• Other study ID #: RLP-man-RCT
• 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
• 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

Related Conditions & MeSH terms

• Fertility
• Gender Role
• Lifestyle
• Pregnancy
• Sexual Behavior

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

External Links

•   Homepage of Department of Women's and Children's Health, Uppsala University