Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Understanding Adaptive Challenges Associated With Male-factor Infertility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02607098
Recruitment Status : Completed
First Posted : November 17, 2015
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease
Male-factor Infertility

Layout table for study information
Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Understanding Adaptive Challenges Associated With Male-factor Infertility
Study Start Date : November 2015
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607098


Locations
Layout table for location information
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United Kingdom
Newcastle Fertility Centre
Newcastle-upon-Tyne, England, United Kingdom
Sponsors and Collaborators
Duke University
Investigators
Layout table for investigator information
Principal Investigator: Eleanor Stevenson, Ph.D. Duke University

Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02607098    
Other Study ID Numbers: Pro00065075
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Genital Diseases, Male
Genital Diseases, Female