Ovarian Functions in Flight AttendantsNCT03809338
Ovarian Functions in Flight Attendants
An observational study of Ovarian Functions in Flight Attendants, run by Acibadem Fulya Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the effects of night sleep disorder and sleeplessness, excessive hours spent on flight and UV radiation exposure over ovarian function in flight attendant women. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Functions in Flight Attendants
- What is being tested?
- amh test
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 1 Apr 2020
- 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 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 50 flight attendants and 50 control patients
Who may be able to join
- day working women , 25-35 years old
- night working women , 25-35 years old
- flight attendant women, 25-35 years old
Who cannot join
- those who cannot enter the groups above
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem Fulya Hospital
Istanbul
Ercan Bastu, MSc, MD, ercanbastu@gmail.com
Ercan Bastu, MSc, MD
About this study
Official title: Evaluation of Antral Follicle Count and Amh Values in Women Working at Night and Flight Attendants
The aim of this study was to evaluate the effects of night sleep disorder and sleeplessness, excessive hours spent on flight and UV radiation exposure over ovarian function in flight attendant women.
Read the detailed description
The aim of this study was to evaluate the effects of night sleep disorder and sleeplessness, excessive hours spent on flight and UV radiation exposure over ovarian function in flight attendant women.
On the third day of the menstrual period, evaluate the number of antral follicle count will be examined and the level of hormones showing the ovarian functions will be measured in the blood sample given by the participant.
- Conditions
- Ovarian Functions in Flight Attendants
- Being tested
- amh test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amh testDiagnostic test
Also called Day 3 antral follicle with transvaginal ultrasonography
Antral follicle count with ultrasound on the 3rd day of menstruation
| Study group | Role | What they receive |
|---|---|---|
| flight attendant women | Assesment antral follicle count on day 3 5ml blood sample to be taken Receives: Diagnostic Test: amh test | |
| day working women | Assesment antral follicle count on day 3 5ml blood sample to be taken Receives: Diagnostic Test: amh test |
What is being measured
The primary outcome is the main question the study is designed to answer.
level of amh
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Mar 2019
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian Functions in Flight AttendantsStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem Fulya Hastanesi
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809338
- Sponsor's protocol ID
- AcibademFulyaH
- Status last verified
- Aug 2019
- First submitted
- 17 Jan 2019
- Last updated
- 19 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antral Follicle Count and Amh Values in Women Working at Night and Flight Attendants
- ClinicalTrials.gov ID
- NCT03809338
- Acronym / sponsor ID
- AcibademFulyaH
- Conditions
- Ovarian Functions in Flight Attendants
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Acibadem Fulya HastanesiResearch network
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 18 Jan 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.
The aim of this study was to evaluate the effects of night sleep disorder and sleeplessness, excessive hours spent on flight and UV radiation exposure over ovarian function in flight attendant women.
Detailed description
The aim of this study was to evaluate the effects of night sleep disorder and sleeplessness, excessive hours spent on flight and UV radiation exposure over ovarian function in flight attendant women.
On the third day of the menstrual period, evaluate the number of antral follicle count will be examined and the level of hormones showing the ovarian functions will be measured in the blood sample given by the participant.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| flight attendant women | – | Diagnostic Test: amh testAssesment antral follicle count on day 3 5ml blood sample to be taken |
| day working women | – | Diagnostic Test: amh testAssesment antral follicle count on day 3 5ml blood sample to be taken |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 50 flight attendants and 50 control patients
Key inclusion criteria (3 listed)
- day working women , 25-35 years old
- night working women , 25-35 years old
- flight attendant women, 25-35 years old
Key exclusion criteria (1 listed)
- those who cannot enter the groups above
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 |
|---|---|---|
| amh testAlso: Day 3 antral follicle with transvaginal ultrasonographyAntral follicle count with ultrasound on the 3rd day of menstruation | Diagnostic test | day working women, flight attendant women |
Primary outcome
level of amh
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Functions in Flight Attendants, run by Acibadem Fulya Hastanesi 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 3 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: status not confirmed, as of the sponsor's last update on 19 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ercan bastu, 1 (+905324134195, ercanbastu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of amh (time frame: one year). 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 19 Aug 2019.