Oxidative StressNCT02401997
The Effect of the Sexual Abstinence Period on the Production of Reactive Oxygen Species in Patients Who Planned to Take Part in Intrauterine Insemination
A study testing sexual abstinence in people with Oxidative Stress, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
To determine the ideal sexual abstinence time for producing high quality sperm Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- sexual abstinence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2014to Jun 2015
- Phase
- Interventional
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who had made an application to Gazi University Obstetrics and Gynecology clinic for infertility and planned to have IUI (intrauterine insemination)
Who cannot join
- Erectile dysfunction- improper semen collection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Obstetrics and Gynecology Clinic
Ankara
About this study
To determine the ideal sexual abstinence time for producing high quality sperm
- Conditions
- Oxidative Stress
- Being tested
- sexual abstinence
- Keywords
- sperm, oxidative stress, sexual abstinence
- Medical subject headings
- Sexual Abstinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sexual abstinenceBehavioural
The subjects participated in the study are divided into three groups according to the male partners sexual abstinence period during the day of sperm preparation for intrauterine insemination.
| Study group | Role | What they receive |
|---|---|---|
| sexual abstinence period group I | Active comparator | The subjects participated in the study are divided into three groups according to the male partners sexual abstinence period during the day of sperm preparation for intrauterine insemination. Group I male partners have sexual abstinence period of 2 days or less. Receives: Behavioral: sexual abstinence |
| sexual abstinence period group II | Active comparator | The subjects participated in the study are divided into three groups according to the male partners sexual abstinence period during the day of sperm preparation for intrauterine insemination. Group II male partners have sexual abstinence period of 2 to 4 days. Receives: Behavioral: sexual abstinence |
| sexual abstinence period group III | Active comparator | The subjects participated in the study are divided into three groups according to the male partners sexual abstinence period during the day of sperm preparation for intrauterine insemination. Group II male partners have sexual abstinence period of more than 4 days Receives: Behavioral: sexual abstinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of sexual abstinence period on oxidative stress status of seminal plasma collected for homologous artificial insemination
The study population is grouped according to the husbands sexual abstinence period before the time of sperm collection for homologous artificial insemination as 0-2 days vs 2-4 days vs 4-6 days
Measured: 0-2 days vs 2-4 days vs 4-6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Ahmet ERDEM, MD, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401997
- Sponsor's protocol ID
- 01/2011-110
- Status last verified
- Aug 2015
- First submitted
- 12 Mar 2015
- Last updated
- 6 Aug 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Sexual Abstinence Period on the Production of Reactive Oxygen Species in Patients Who Planned to Take Part in Intrauterine Insemination
- ClinicalTrials.gov ID
- NCT02401997
- Acronym / sponsor ID
- 01/2011-110
- Conditions
- Oxidative Stress
- Keywords
- sperm, oxidative stress, sexual abstinence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 30 Mar 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.
To determine the ideal sexual abstinence time for producing high quality sperm
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| sexual abstinence period group I | Active comparator | Behavioral: sexual abstinenceThe subjects participated in the study are divided into three groups according to the male partners sexual abstinence period during the day of sperm preparation for intrauterine insemination. Group I male partners have sexual abstinence period of 2 days or less. |
| sexual abstinence period group II | Active comparator | Behavioral: sexual abstinenceThe subjects participated in the study are divided into three groups according to the male partners sexual abstinence period during the day of sperm preparation for intrauterine insemination. Group II male partners have sexual abstinence period of 2 to 4 days. |
| sexual abstinence period group III | Active comparator | Behavioral: sexual abstinenceThe subjects participated in the study are divided into three groups according to the male partners sexual abstinence period during the day of sperm preparation for intrauterine insemination. Group II male partners have sexual abstinence period of more than 4 days |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who had made an application to Gazi University Obstetrics and Gynecology clinic for infertility and planned to have IUI (intrauterine insemination)
Key exclusion criteria (1 listed)
- Erectile dysfunction- improper semen collection
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 |
|---|---|---|
| sexual abstinenceThe subjects participated in the study are divided into three groups according to the male partners sexual abstinence period during the day of sperm preparation for intrauterine insemination. | Behavioural | sexual abstinence period group I, sexual abstinence period group II, sexual abstinence period group III |
Primary outcome
Effect of sexual abstinence period on oxidative stress status of seminal plasma collected for homologous artificial insemination
Time frame: 0-2 days vs 2-4 days vs 4-6 days
The study population is grouped according to the husbands sexual abstinence period before the time of sperm collection for homologous artificial insemination as 0-2 days vs 2-4 days vs 4-6 days
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 6 Aug 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sexual abstinence in people with Oxidative Stress, run by Gazi University at 1 site in Turkey (Türkiye).
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 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Effect of sexual abstinence period on oxidative stress status of seminal plasma collected for homologous artificial insemination (time frame: 0-2 days vs 2-4 days vs 4-6 days). 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 6 Aug 2015.