Male InfertilityNCT04178954
Semen Analysis and Insight Into Male Infertility
An observational study of Male Infertility, run by Batool Mutar.
Trial summary
Semen analysis is the cornerstone for the valuation of the male partner in the infertile couples. This test has been standardized throughout the world through the World Health Organization (WHO) since the1970s by producing, editing, updating, and disseminating a semen analysis manual and guidelines. Read more about this study
- Who is it for?
- Ages 15 to 60 years, men only
- Conditions the study is for
- Male Infertility
- What is being tested?
- semen fluid analysis
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Sep 2019
- 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 15 to 60 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: infertile males
Who may be able to join
- infertile males
Who cannot join
- suergery
About this study
Semen analysis is the cornerstone for the valuation of the male partner in the infertile couples. This test has been standardized throughout the world through the World Health Organization (WHO) since the1970s by producing, editing, updating, and disseminating a semen analysis manual and guidelines.
Read the detailed description
A retrospective study to assess the frequency of male factor infertility in the last years.
- Conditions
- Male Infertility
- Being tested
- semen fluid analysis
- Keywords
- Infertility;, male, semen
- Medical subject headings
- Infertility, Male, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semen fluid analysisDiagnostic test
semen fluid analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Count and motility
low count
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start1 Jan 2016
- Primary completion30 May 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Batool Mutar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Batool Mutar, Al-Kindy College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178954
- Sponsor's protocol ID
- 11 Al-KindyCM
- Status last verified
- Dec 2019
- First submitted
- 24 Nov 2019
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semen Analysis and Insight Into Male Infertility
- ClinicalTrials.gov ID
- NCT04178954
- Acronym / sponsor ID
- 11 Al-KindyCM
- Conditions
- Male Infertility
- Keywords
- Infertility;, male, semen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Batool MutarUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 26 Nov 2019 (actual)
- 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.
Semen analysis is the cornerstone for the valuation of the male partner in the infertile couples. This test has been standardized throughout the world through the World Health Organization (WHO) since the1970s by producing, editing, updating, and disseminating a semen analysis manual and guidelines.
Detailed description
A retrospective study to assess the frequency of male factor infertility in the last years.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 15 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- infertile males
Key inclusion criteria (1 listed)
- infertile males
Key exclusion criteria (1 listed)
- suergery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semen fluid analysissemen fluid analysis | Diagnostic test | – |
Primary outcome
Count and motility
Time frame: 4 years
low count
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 May 2023.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility, run by Batool Mutar.
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 1 inclusion and 1 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 May 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Count and motility (time frame: 4 years). 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 May 2023.