Estrogen and the Outer Eye in Women During Fertility Treatment

February 25, 2014 updated by: Meir Medical Center

The Influence of the Hormonal Fertility Treatment of Women, on the Eye Surface and the Eye Dryness

The purpose of this study is to determine the relation between estrogen and progesterone levels, and between dryness of the eyes, in women during their fertile years.

Study Overview

Status

Unknown

Conditions

Detailed Description

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:

  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

Collection and summary of all the data End of the research

Study Type

Observational

Enrollment (Anticipated)

30

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

fertility clinic patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
women during fertility treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of clinically definite dry eye confirmed by Schirmer test and tear break up time test
Time Frame: 24 days
24 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: 0 days, 10 days
0 days, 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

July 1, 2014

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

February 25, 2014

First Posted (Estimate)

February 26, 2014

Study Record Updates

Last Update Posted (Estimate)

February 26, 2014

Last Update Submitted That Met QC Criteria

February 25, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOEDFT-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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