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出境医 / 临床实验 / Ovarian Functions in Flight Attendants
Ovarian Functions in Flight Attendants
Study Description
Brief 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.
| Condition or disease | Intervention/treatment |
|---|---|
| Ovarian Functions in Flight Attendants | Diagnostic Test: amh test |
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
| Study Type : | Observational |
| Estimated Enrollment : | 300 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | Evaluation of Antral Follicle Count and Amh Values in Women Working at Night and Flight Attendants |
| Actual Study Start Date : | March 1, 2019 |
| Estimated Primary Completion Date : | March 1, 2020 |
| Estimated Study Completion Date : | April 1, 2020 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
flight attendant women
Assesment antral follicle count on day 3 5ml blood sample to be taken
|
Diagnostic Test: amh test
Antral follicle count with ultrasound on the 3rd day of menstruation
Other Name: Day 3 antral follicle with transvaginal ultrasonography
|
|
day working women
Assesment antral follicle count on day 3 5ml blood sample to be taken
|
Diagnostic Test: amh test
Antral follicle count with ultrasound on the 3rd day of menstruation
Other Name: Day 3 antral follicle with transvaginal ultrasonography
|
Outcome Measures
Primary Outcome Measures :
- level of amh [ Time Frame: one year ]
Biospecimen Retention: Samples Without DNA
5 ml blood sample
Eligibility Criteria
| Ages Eligible for Study: | 25 Years to 35 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | evaluation ovarian functions of women |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
50 flight attendants and 50 control patients
Criteria
Inclusion Criteria:
- day working women , 25-35 years old
- night working women , 25-35 years old
- flight attendant women, 25-35 years old
Exclusion Criteria:
- those who cannot enter the groups above
Contacts and Locations
Contacts
| Contact: ercan bastu, 1 | +905324134195 | ercanbastu@gmail.com | |
| Contact: yucel kocyigit, 2 | +905057006643 | yucelkocyigit@hotmail.com |
Locations
| Turkey | |
| Acibadem Fulya Hospital | Recruiting |
| Istanbul, Turkey | |
| Contact: Ercan Bastu, MSc, MD ercanbastu@gmail.com | |
| Principal Investigator: Ercan Bastu, MSc, MD | |
Sponsors and Collaborators
Acibadem Fulya Hastanesi
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | January 17, 2019 | ||||||||
| First Posted Date | January 18, 2019 | ||||||||
| Last Update Posted Date | August 19, 2019 | ||||||||
| Actual Study Start Date | March 1, 2019 | ||||||||
| Estimated Primary Completion Date | March 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
level of amh [ Time Frame: one year ] | ||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Ovarian Functions in Flight Attendants | ||||||||
| Official Title | Evaluation of Antral Follicle Count and Amh Values in Women Working at Night and Flight Attendants | ||||||||
| Brief 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. | ||||||||
| 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. |
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| Study Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Cross-Sectional |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description:
5 ml blood sample
|
||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | 50 flight attendants and 50 control patients | ||||||||
| Condition | Ovarian Functions in Flight Attendants | ||||||||
| Intervention | Diagnostic Test: amh test
Antral follicle count with ultrasound on the 3rd day of menstruation
Other Name: Day 3 antral follicle with transvaginal ultrasonography
|
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
300 | ||||||||
| Original Estimated Enrollment |
4 | ||||||||
| Estimated Study Completion Date | April 1, 2020 | ||||||||
| Estimated Primary Completion Date | March 1, 2020 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 25 Years to 35 Years (Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
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| Listed Location Countries | Turkey | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03809338 | ||||||||
| Other Study ID Numbers | AcibademFulyaH | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement |
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| Responsible Party | Acibadem Fulya Hastanesi | ||||||||
| Study Sponsor | Acibadem Fulya Hastanesi | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | Acibadem Fulya Hastanesi | ||||||||
| Verification Date | August 2019 | ||||||||
