Ovarian Functions in Flight Attendants | NCT03809338

Studies
Ovarian Functions in Flight Attendants

NCT03809338

Sponsor

Acibadem Fulya Hastanesi

Status

Unknown status

Last Update Posted

Aug 19, 2019Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Ovarian Functions in Flight Attendants

Interventions

amh test

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2019Actual

Primary Completion Date

Mar 1, 2020Estimated

Completion Date

Apr 1, 2020Estimated

First Submitted Date

Jan 17, 2019

First Submission Date that Met QC Criteria

Jan 17, 2019

First Posted Date

Jan 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2019

Last Update Posted Date

Aug 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
flight attendant women		Assesment antral follicle count on day 3 5ml blood sample to be taken	Diagnostic Test: amh test
day working women		Assesment antral follicle count on day 3 5ml blood sample to be taken	Diagnostic Test: amh test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
amh test	Diagnostic Test	Antral follicle count with ultrasound on the 3rd day of menstruation	day working women flight attendant women

Measure	Description	Time Frame
level of amh		one year

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

evaluation ovarian functions of women

Minimum Age

25 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

50 flight attendants and 50 control patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
ercan bastu, 1	Contact	+905324134195		ercanbastu@gmail.com
yucel kocyigit, 2	Contact	+905057006643		yucelkocyigit@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Acibadem Fulya Hospital	Recruiting	Istanbul			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided