Male-factor InfertilityNCT02607098
Understanding Adaptive Challenges Associated With Male-factor Infertility
An observational study of Male-factor Infertility, run by Duke University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Male-factor Infertility
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2015to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- living children, either biological or adoptive
- history of vasectomy
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
United Kingdom1 site
Newcastle Fertility Centre
Newcastle upon Tyne, England
About this study
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.
- Conditions
- Male-factor Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, as measured by the percentage of eligible subjects agreed to participate
Measured: 6 months
Feasibility, as measured by retention percentage
Measured: 6 months
Secondary outcomes (9)
Change in level of global infertility stress, as measured by questionnaire
Measured: Baseline, 6 months
Change in quality of life, as measured by questionnaire
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 months
Concordance between men and partners with respect to quality of life, as measured by questionnaire
Measured: 3 months
Concordance between men and partners with respect to levels of global infertility stress, as measured by questionnaire
Measured: 6 months
Concordance between men and partners with respect to quality of life, as measured by questionnaire
Measured: 6 months
Feasibility, as measured by percentage of participants who used text messaging to complete their study questionnaires
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male-factor InfertilityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eleanor Stevenson, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607098
- Sponsor's protocol ID
- Pro00065075
- Status last verified
- Jan 2017
- First submitted
- 13 Nov 2015
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Adaptive Challenges Associated With Male-factor Infertility
- ClinicalTrials.gov ID
- NCT02607098
- Acronym / sponsor ID
- Pro00065075
- Conditions
- Male-factor Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (8 listed)
- 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
- 18 to 40 years of age
Key exclusion criteria (2 listed)
- living children, either biological or adoptive
- history of vasectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
Related trials for Male-factor Infertility
Active, not recruitingObservational study
Sperm Selection Strategies and Male-Factor Phenotypes in ICSI
Assisted Reproductive Technology, Assisted Reproductive Technology Outcomes
Recruiting
Hormone-free Antral Retrieval for Viable Embryo Storage & Transfer
Infertility
Active, not recruiting
A Randomized Clinical Trial Comparing Embryo Euploidy Rates Following Ultrashort Versus Standard Abstinence
Infertility, Male Factor Infertility
RecruitingPhase 2/3
PKB171 Against Placebo in Couples With Mild Male Factor Infertility
Infertility Due to Azoospermia
RecruitingObservational study
Towards Optimal Fertility, Fathering and Fatherhood studY
Reproductive Issues, Fertility Issues
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleanor Stevenson, Ph.D. principal investigator
Duke University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male-factor Infertility, run by Duke University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility, as measured by the percentage of eligible subjects agreed to participate (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2017.