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OpenTrials
Completed

NCT Number: NCT02607098

Understanding Adaptive Challenges Associated With Male-factor Infertility

The purpose of this study is to understand the experience of men and their partners when diagnosed with male-factor infertility while trying to achieve a pregnancy and the skills they use to adapt to this diagnosis.

Completed

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Key information

Conditions

Male-factor Infertility

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Newcastle Fertility Centre, Newcastle upon Tyne, England, United Kingdom

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Men:

  • in a partnered relationship with a female
  • have been trying without success to conceive a pregnancy
  • have been referred due to suspected or diagnosed male-factor infertility
  • have the ability to read and write English

Female Partner:

  • 18 to 40 years of age
  • ability to read and write English

Exclusion criteria

  • living children, either biological or adoptive
  • history of vasectomy

Treatment and study plan

Primary outcomes

  1. Feasibility, as measured by the percentage of eligible subjects agreed to participate

    Time frame: 6 months

  2. Feasibility, as measured by retention percentage

    Time frame: 6 months

Secondary outcomes

  1. Change in level of global infertility stress, as measured by questionnaire

    Time frame: Baseline, 6 months

  2. Change in quality of life, as measured by questionnaire

    Time frame: Baseline, 6 months

  3. Change in level of global infertility stress, as measured by questionnaire

    Time frame: Pre and post significant event, up to 7 months

    The investigators will determine the change in pre and post significant event (when reported, such as new diagnosis, IVF/ICSI, discontinuation of treatment) level of global infertility stress in both the man and his partner.

  4. Change in quality of life, as measured by questionnaire

    Time frame: Pre and post significant event, up to 7 months

    The investigators will determine the change in pre and post significant event (when reported, such as new diagnosis, IVF/ICSI, discontinuation of treatment) level of quality of life in both the man and his partner.

  5. Concordance between men and partners with respect to levels of global infertility stress, as measured by questionnaire

    Time frame: 3 months

  6. Concordance between men and partners with respect to quality of life, as measured by questionnaire

    Time frame: 3 months

  7. Concordance between men and partners with respect to levels of global infertility stress, as measured by questionnaire

    Time frame: 6 months

  8. Concordance between men and partners with respect to quality of life, as measured by questionnaire

    Time frame: 6 months

  9. Feasibility, as measured by percentage of participants who used text messaging to complete their study questionnaires

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2015
Registry last updated
Mar 1, 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.