Understanding Adaptive Challenges Associated With Male-factor Infertility

Duke University24 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Male-factor Infertility

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (2)

Duke University Medical Center

Durham, North Carolina, United States

Newcastle Fertility Centre

Newcastle upon Tyne, England, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 6 months

Feasibility, as measured by retention percentage

Time frame: 6 months

Secondary Outcomes

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

Time frame: Baseline, 6 months

Change in quality of life, as measured by questionnaire

Time frame: Baseline, 6 months

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

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.

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

Change in quality of life, as measured by questionnaire

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.

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

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

Time frame: 3 months

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

Time frame: 3 months

Data from ClinicalTrials.gov

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