- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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
Studietyp
Inskrivning (Förväntat)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
|---|
|
women during fertility treatment
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Evidence of clinically definite dry eye confirmed by Schirmer test and tear break up time test
Tidsram: 24 days
|
24 days
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
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)
Tidsram: 0 days, 10 days
|
0 days, 10 days
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EOEDFT-2
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