Salivary AmylaseNCT02664480
Assesment of Salivary Alpha-amylase Levels Before and After Ovulation
An observational study of Salivary Amylase, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
Trial summary
Investigators aimed to investigate whether there is an association between ovulation and salivatory alpha amylase (sAA) activity in menstrual cycles during a month period in a group of reproductive women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Salivary Amylase
- What is being tested?
- Salivary alpha-Amylases
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Mar 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pcos women will included the study population. Because ovulation don't happen.
Who may be able to join
- Clinical diagnosis of PCOS (study group)
- Reproductive age regular menses women
Who cannot join
- pregnancy,
- breastfeeding,
- known liver disease,
- alcohol abuse,
- diabetes mellitus,
- smoking
- treatment with oral glucocorticoids
- treatment with hormonal contraceptives.
About this study
Official title: Assesment of Salivary Alpha-amylase Levels Before and After Ovulation: A Randomized Controlled Trial
Investigators aimed to investigate whether there is an association between ovulation and salivatory alpha amylase (sAA) activity in menstrual cycles during a month period in a group of reproductive women.
Read the detailed description
Saliva is a readily available specimen, which can be collected by noninvasive procedures and contains many hormones, drugs and antibodies of interest in screening and diagnosis. With a salivary specimen, one can collect multiple specimens at the optimum times for diagnostic information. Saliva can be collected in remote sites by unskilled personnel and, is stable at ambient temperatures for several weeks. Because of diurnal and monthly variations, several steroid hormones need multiple samples collected early in the morning or late at night or at the same time every day for a month to give meaningful results. Such collections are often very expensive, inconvenient or impossible to do with blood.
Investigators aimed to investigate whether there is an association between ovulation and salivatory alpha amylase (sAA) activity in menstrual cycles during a month period in a group of reproductive women.
- Conditions
- Salivary Amylase
- Being tested
- Salivary alpha-Amylases
- Keywords
- Salivary Alpha-amylase, ovulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary alpha-AmylasesOther
Investigators will collect Salivary alpha-Amylases before and after ovulation
| Study group | Role | What they receive |
|---|---|---|
| study group | Reproductive age women with polycystic ovary syndrome and irregular menses (Salivary Alpha-amylase Levels of 3rd and 24th day of menstrual cyclus) Receives: Other: Salivary alpha-Amylases | |
| control group | Reproductive age women with regular menses (Salivary Alpha-amylase level of 3rd and 24th day of menstrual cyclus) Receives: Other: Salivary alpha-Amylases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Salivary Alpha-amylase activity
Saliva samples will be taken 2 times during the menstrual cyclus (3th day and 24th day).
Measured: 3rd and 24th day of menstrual cyclus
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionFeb 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary AmylaseStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ozturk, Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
- Investigators
- Mustafa Öztürk, M.D, Principal investigator, Etimesgut Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02664480
- Sponsor's protocol ID
- Gulhane School of Medicine
- Status last verified
- Jan 2016
- First submitted
- 11 Jan 2016
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Salivary Alpha-amylase Levels Before and After Ovulation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02664480
- Acronym / sponsor ID
- Gulhane School of Medicine
- Conditions
- Salivary Amylase
- Keywords
- Salivary Alpha-amylase, ovulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gulhane Tip FakultesiUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 27 Jan 2016 (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.
Investigators aimed to investigate whether there is an association between ovulation and salivatory alpha amylase (sAA) activity in menstrual cycles during a month period in a group of reproductive women.
Detailed description
Saliva is a readily available specimen, which can be collected by noninvasive procedures and contains many hormones, drugs and antibodies of interest in screening and diagnosis. With a salivary specimen, one can collect multiple specimens at the optimum times for diagnostic information. Saliva can be collected in remote sites by unskilled personnel and, is stable at ambient temperatures for several weeks. Because of diurnal and monthly variations, several steroid hormones need multiple samples collected early in the morning or late at night or at the same time every day for a month to give meaningful results. Such collections are often very expensive, inconvenient or impossible to do with blood.
Investigators aimed to investigate whether there is an association between ovulation and salivatory alpha amylase (sAA) activity in menstrual cycles during a month period in a group of reproductive women.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: Salivary alpha-AmylasesReproductive age women with polycystic ovary syndrome and irregular menses (Salivary Alpha-amylase Levels of 3rd and 24th day of menstrual cyclus) |
| control group | – | Other: Salivary alpha-AmylasesReproductive age women with regular menses (Salivary Alpha-amylase level of 3rd and 24th day of menstrual cyclus) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pcos women will included the study population. Because ovulation don't happen.
Key inclusion criteria (2 listed)
- Clinical diagnosis of PCOS (study group)
- Reproductive age regular menses women
Key exclusion criteria (8 listed)
- pregnancy,
- breastfeeding,
- known liver disease,
- alcohol abuse,
- diabetes mellitus,
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 |
|---|---|---|
| Salivary alpha-AmylasesInvestigators will collect Salivary alpha-Amylases before and after ovulation | Other | control group, study group |
Primary outcome
Changes of Salivary Alpha-amylase activity
Time frame: 3rd and 24th day of menstrual cyclus
Saliva samples will be taken 2 times during the menstrual cyclus (3th day and 24th day).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
- Individual participant dataSharing planned: No
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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.
Mustafa Öztürk, M.D principal investigator
Etimesgut Military Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Salivary Amylase, run by Saglik Bilimleri Universitesi Gulhane Tip Fakultesi.
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 8 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: status not confirmed, as of the sponsor's last update on 27 Jan 2016. 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?
Results are not available in the source record.
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?
Changes of Salivary Alpha-amylase activity (time frame: 3rd and 24th day of menstrual cyclus). 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 27 Jan 2016.