Male-factor Infertility Clinical Trial
Official title:
Understanding Adaptive Challenges Associated With Male-factor Infertility
| Verified date | January 2017 |
| Source | Duke University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | November 2016 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 50 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Newcastle Fertility Centre | Newcastle-upon-Tyne | England |
| United States | Duke University Medical Center | Durham | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Duke University |
United States, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Feasibility, as measured by the percentage of eligible subjects agreed to participate | 6 months | ||
| Primary | Feasibility, as measured by retention percentage | 6 months | ||
| Secondary | Change in level of global infertility stress, as measured by questionnaire | Baseline, 6 months | ||
| Secondary | Change in quality of life, as measured by questionnaire | Baseline, 6 months | ||
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Concordance between men and partners with respect to levels of global infertility stress, as measured by questionnaire | 3 months | ||
| Secondary | Concordance between men and partners with respect to quality of life, as measured by questionnaire | 3 months | ||
| Secondary | Concordance between men and partners with respect to levels of global infertility stress, as measured by questionnaire | 6 months | ||
| Secondary | Concordance between men and partners with respect to quality of life, as measured by questionnaire | 6 months | ||
| Secondary | Feasibility, as measured by percentage of participants who used text messaging to complete their study questionnaires | 6 months |