Durham, North Carolina 27710

  • factor Infertility

Purpose:

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.


Criteria:

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 is Available At:


Original ID:

Pro00065075


NCT ID:

NCT02607098


Secondary ID:


Study Acronym:


Brief Title:

Understanding Adaptive Challenges Associated With Male-factor Infertility


Official Title:

Understanding Adaptive Challenges Associated With Male-factor Infertility


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Duke University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

24


Enrollment Type:

Actual


Overall Contact Information

Official Name:Eleanor Stevenson, Ph.D.
Principal Investigator
Duke University

Study Dates

Start Date:November 2015
Completion Date:November 2016
Completion Type:Actual
Primary Completion Date:November 2016
Primary Completion Type:Actual
Verification Date:January 2017
Last Changed Date:February 28, 2017
First Received Date:November 13, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Feasibility, as measured by percentage of participants who used text messaging to complete their study questionnaires
Time Frame:6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Concordance between men and partners with respect to quality of life, as measured by questionnaire
Time Frame:6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Concordance between men and partners with respect to levels of global infertility stress, as measured by questionnaire
Time Frame:6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Concordance between men and partners with respect to quality of life, as measured by questionnaire
Time Frame:3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Concordance between men and partners with respect to levels of global infertility stress, as measured by questionnaire
Time Frame:3 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in quality of life, as measured by questionnaire
Time Frame:Pre and post significant event, up to 7 months
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Change in level of global infertility stress, as measured by questionnaire
Time Frame:Pre and post significant event, up to 7 months
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Change in quality of life, as measured by questionnaire
Time Frame:Baseline, 6 months
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in level of global infertility stress, as measured by questionnaire
Time Frame:Baseline, 6 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Feasibility, as measured by retention percentage
Time Frame:6 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Feasibility, as measured by the percentage of eligible subjects agreed to participate
Time Frame:6 months
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Female partners
Description: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.
Study Arm Type:Other
Arm Name:Males diagnosed with male-factor infertility
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Duke University

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: March 26, 2020

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