Overview

This trial is active, not recruiting.

Condition male-factor infertility
Sponsor Duke University
Start date November 2015
End date January 2017
Trial size 24 participants
Trial identifier NCT02607098, Pro00065075

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
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.

Primary Outcomes

Measure
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

Measure
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
time frame: Pre and post significant event, up to 7 months
Change in quality of life, as measured by questionnaire
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
Concordance between men and partners with respect to levels of global infertility stress, as measured by questionnaire
time frame: 6 months
Concordance between men and partners with respect to quality of life, as measured by questionnaire
time frame: 6 months
Feasibility, as measured by percentage of participants who used text messaging to complete their study questionnaires
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

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

Additional Information

Official title Understanding Adaptive Challenges Associated With Male-factor Infertility
Principal investigator Eleanor Stevenson, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Duke University.