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.

Study Overview

• Status: Completed
• Conditions: Male-factor Infertility

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Newcastle-upon-Tyne, England, United Kingdom
      • Newcastle Fertility Centre
• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will recruit a convenience sample of 10 men and their partners seeking consultation from a fertility urologist following the detection of male-factor infertility.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Males diagnosed with male-factor infertility; This study will recruit a convenience sample of 10 men and their partners seeking consultation from a fertility urologist following the detection of male-factor infertility.
Female partners; This study will recruit a convenience sample of 10 men and their partners seeking consultation from a fertility urologist following the detection of male-factor infertility.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility, as measured by the percentage of eligible subjects agreed to participate	6 months
Feasibility, as measured by retention percentage	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in level of global infertility stress, as measured by questionnaire		Baseline, 6 months
Change in quality of life, as measured by questionnaire		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.	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.	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		3 months
Concordance between men and partners with respect to quality of life, as measured by questionnaire		3 months
Concordance between men and partners with respect to levels of global infertility stress, as measured by questionnaire		6 months
Concordance between men and partners with respect to quality of life, as measured by questionnaire		6 months
Feasibility, as measured by percentage of participants who used text messaging to complete their study questionnaires		6 months

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Eleanor Stevenson, Ph.D., Duke University

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: November 13, 2015
• First Submitted That Met QC Criteria: November 13, 2015
• First Posted (Estimate): November 17, 2015

Study Record Updates

• Last Update Posted (Actual): March 1, 2017
• Last Update Submitted That Met QC Criteria: February 28, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: Pro00065075