Infertility, MaleNCT06241495
Aromatherapy in Providing a Semen Sample
A study testing Aromatherapy in people with Infertility, Male, run by Menekşe Nazlı AKER at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of aromatherapy on the anxiety and difficulty of providing a semen sample and on semen volume, sperm concentration and motility percentage. The study will be carried out in two different groups. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Male
- What is being tested?
- Aromatherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jan 2024to 30 Aug 2024
- 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 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Having applied to the center where the research will be conducted with a complaint of infertility
- Being 18 years or older
Who cannot join
- Individuals giving up on participating in the study
- Participant not being able to provide a semen sample
- Being diagnosed with azoospermia-oligozoospermia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Fertility Diagnosis, Treatment, Research and Application Center
Ankara
About this study
Official title: The Effect of Aromatherapy on Anxiety, Difficulty in Providing a Semen Sample and Semen Parameters
The aim of this study is to evaluate the effect of aromatherapy on the anxiety and difficulty of providing a semen sample and on semen volume, sperm concentration and motility percentage.
The study will be carried out in two different groups. After the men are evaluated in terms of eligibility criteria for the research, the men who are eligible will be informed about the research and written informed consent will be obtained from the men who accept. The random distribution of men to the study groups will be carried out random. The following applications will be made to the groups. Aromatherapy/placebo will be applied to the individuals included in the study. During the semen sample giving process, lavender oil/coconut oil (placebo) will be applied with a diffuser.
- Conditions
- Infertility, Male
- Being tested
- Placebo, Aromatherapy
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo oil will be applied to the individuals included in the study. During the semen sample giving process, coconut oil (placebo) will be applied with a diffuser.
AromatherapyOther
Aromatherapy will be applied to the individuals included in the study. During the semen sample giving process, lavender oil will be applied with a diffuser.
| Study group | Role | What they receive |
|---|---|---|
| Aromatherapy | Experimental | Not described Receives: Other: Aromatherapy |
| Control Group | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in anxiety
The State-Trait Anxiety Inventory-S consist of 20 items with four points likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.
Measured: before providing a semen sample, immediately after providing a semen sample
Anxiety about providing a semen sample
VAS is a 10-cm-long measurement tool. The left end of the scale reads "no anxiety " and the right end reads "very anxious". A high score on the scale indicated a high level of anxiety and a score of 0 pointed to no anxiety.
Measured: immediately after providing a semen sample
Difficulty providing a semen sample
VAS is a 10-cm-long measurement tool. The left end of the scale reads "not difficult" and the right end reads "very difficult ". A high score on the scale indicated a high level of difficulty and a score of 0 pointed to no difficulty.
Measured: immediately after providing a semen sample
Secondary outcomes (5)
Semen volume
Volume of semen sample
Measured: immediately after providing a semen sample
sperm concentration
sperm concentration of semen sample
Measured: immediately after providing a semen sample
sperm motility percentage
sperm motility percentage of semen sample
Measured: immediately after providing a semen sample
Total sperm count
Total sperm count of semen sample
Measured: immediately after providing a semen sample
Satisfaction with the oil used
VAS is a 10-cm-long measurement tool. The left end of the scale reads "I am not satisfied at all" and the right end reads "very satisfied". A high score on the scale indicated a high level of satisfied and a score of 0 pointed to no satisfied.
Measured: immediately after providing a semen sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start29 Jan 2024
- Primary completion28 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menekşe Nazlı AKER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Menekşe Nazlı AKER, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06241495
- Sponsor's protocol ID
- İ04-205-23
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy on Anxiety, Difficulty in Providing a Semen Sample and Semen Parameters
- ClinicalTrials.gov ID
- NCT06241495
- Acronym / sponsor ID
- İ04-205-23
- Conditions
- Infertility, Male
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Menekşe Nazlı AKERUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 28 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 5 Feb 2024 (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.
The aim of this study is to evaluate the effect of aromatherapy on the anxiety and difficulty of providing a semen sample and on semen volume, sperm concentration and motility percentage.
The study will be carried out in two different groups. After the men are evaluated in terms of eligibility criteria for the research, the men who are eligible will be informed about the research and written informed consent will be obtained from the men who accept. The random distribution of men to the study groups will be carried out random. The following applications will be made to the groups. Aromatherapy/placebo will be applied to the individuals included in the study. During the semen sample giving process, lavender oil/coconut oil (placebo) will be applied with a diffuser.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aromatherapy | Experimental | Other: Aromatherapy |
| Control Group | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having applied to the center where the research will be conducted with a complaint of infertility
- Being 18 years or older
Key exclusion criteria (3 listed)
- Individuals giving up on participating in the study
- Participant not being able to provide a semen sample
- Being diagnosed with azoospermia-oligozoospermia
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 |
|---|---|---|
| PlaceboPlacebo oil will be applied to the individuals included in the study. During the semen sample giving process, coconut oil (placebo) will be applied with a diffuser. | Other | Control Group |
| AromatherapyAromatherapy will be applied to the individuals included in the study. During the semen sample giving process, lavender oil will be applied with a diffuser. | Other | Aromatherapy |
Primary outcome
Change in anxiety
Time frame: before providing a semen sample, immediately after providing a semen sample
The State-Trait Anxiety Inventory-S consist of 20 items with four points likert scales, each (not at all, somewhat, moderately so, very much so). Scores thus range between 20, indicating a low level of anxiety and 80, indicating a high level.
Anxiety about providing a semen sample
Time frame: immediately after providing a semen sample
VAS is a 10-cm-long measurement tool. The left end of the scale reads "no anxiety " and the right end reads "very anxious". A high score on the scale indicated a high level of anxiety and a score of 0 pointed to no anxiety.
Difficulty providing a semen sample
Time frame: immediately after providing a semen sample
VAS is a 10-cm-long measurement tool. The left end of the scale reads "not difficult" and the right end reads "very difficult ". A high score on the scale indicated a high level of difficulty and a score of 0 pointed to no difficulty.
5 secondary outcomes
Semen volume
Time frame: immediately after providing a semen sample
sperm concentration
Time frame: immediately after providing a semen sample
sperm motility percentage
Time frame: immediately after providing a semen sample
Total sperm count
Time frame: immediately after providing a semen sample
Satisfaction with the oil used
Time frame: immediately after providing a semen sample
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 12 Feb 2025.
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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 Aromatherapy in people with Infertility, Male, run by Menekşe Nazlı AKER 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 2 inclusion and 3 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 12 Feb 2025. 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. Some participants in this study may receive a placebo. 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?
Change in anxiety (time frame: before providing a semen sample, immediately after providing a semen sample). The study lists 3 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 12 Feb 2025.