- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02072122
Estrogen and the Outer Eye in Women During Fertility Treatment
The Influence of the Hormonal Fertility Treatment of Women, on the Eye Surface and the Eye Dryness
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Women during their fertility treatments will be submitted to the research. The research will include 3 meetings with a doctor from the ophthalmology department. Each meeting will be individual for each participant of the research.
The meetings will take place during the day of regular appointment of the participant to the fertility clinic.
Meeting #1:
During first visit to the fertility clinic for the stimulation process.
During this day will be done:
1.Submission of the patient to the research and signing on letter of agreement 2.Blood tests for estrogen, progesterone, luteinizing hormone (LH) 3.Eye examination: 3a. Filling of Schein Questionnaire 3b. Examination of the external eye: 1.microscope, 2.Schirmer test (paper strips inserted into the eye for several minutes to measure the production of tears), 3. tear break up time test (checking the eye with the fluorescein light after painting the eye with fluorescein dye) 3c. Checking the Intra Ocular Pressure with Tonometer
Meeting #2:
During visit to the fertility clinic for the egg collection (about 10 days after meeting #1)
During this day will be done:
1.Blood tests for estrogen, progesterone, luteinizing hormone (LH) 2.Eye examination: 2a. Filling of Schein Questionnaire 2b. Examination of the external eye: 1.microscope, 2.Schirmer test (paper strips inserted into the eye for several minutes to measure the production of tears), 3. tear break up time test (checking the eye with the fluorescein light after painting the eye with fluorescein dye) 2c. Checking the Intra Ocular Pressure with Tonometer
Meeting #3:
During visit to the fertility clinic for the pregnancy test (about 14 days after meeting #2)
During this day will be done:
- Blood tests for estrogen, progesterone, luteinizing hormone (LH)
- Eye examination:
2a. Filling of Schein Questionnaire 2b. Examination of the external eye: 1.microscope, 2.Schirmer test (paper strips inserted into the eye for several minutes to measure the production of tears), 3. tear break up time test (checking the eye with the fluorescein light after painting the eye with fluorescein dye) 2c. Checking the Intra Ocular Pressure with Tonometer
Collection and summary of all the data End of the research
Tipo de estudio
Inscripción (Anticipado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- women during fertility treatment
- without any known eye diseases
- no current or past history of treatment against dry eye
Exclusion Criteria:
- known eye disease
- current or past history of treatment against dry eye
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
---|
women during fertility treatment
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Evidence of clinically definite dry eye confirmed by Schirmer test and tear break up time test
Periodo de tiempo: 24 days
|
24 days
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Evidence of clinically definite dry eye confirmed by Schirmer test and tear break up time test during each on of the meetings #1,#2 (day 0, day 10)
Periodo de tiempo: 0 days, 10 days
|
0 days, 10 days
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EOEDFT-2
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