A New Tool for Automatic Ovarian Follicle Count and it Abilities to Evaluate Ovarian Reserve

March 10, 2013 updated by: Meir Medical Center

The ultrasound unit in Meir Medical Center developed new software to automated ovarian follicle count on the basis of 3D US. The investigators intent to evaluate this software at two steps:

  • To compared the abilities of the software to physician follicle count.
  • To evaluate with the software the antral follicle count, as expression to ovarian reserve at 3 different time of the month.

The investigators believe that the software measurement of the small follicle can be better than the common antral follicle count that is use today, and by this accurate evaluation of the small follicle the investigators can evaluate the ovarian reserve at any time of the mount, and not only at the early follicular phase that use today.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Antral follicle count (AFC) is one of the methods to evaluate ovarian reserve. But this method is not that straightforward with a lot of inter and intra observe variation. In attempt to overcome this problems we going the verified a new software for automated AFC.

At the first step we will compare the human count and the software count of the AFC in 150 exams of ovaries at 3D US.

At the second step we will use the software to evaluate ovarian reserve at 50 women before fertility treatment. This woman will be questioned about epidemiologic data (age, ethnicity, medical history) and evaluate at the early follicular phase with blood test for follicle stimulating hormone, luteinizing hormone , E2, anti-mullerian hormone , Prolactin, thyroid-stimulating hormone, Testosterone, Progesterone, 17-hydroxyprogesterone, dehydroepiandrosterone-Sulphate. The evaluation of the AFC by US will be at early follicular phase, late follicular phase and mid luteal phase

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Fertility unit, Meir Medical Center, Israel

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 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study group will include women faced the fertility unit in Meir Medical Center. Each woman at her first evaluation will invite to volunteer. Also woman during a natural course treatment will invite to volunteer.

Description

Inclusion Criteria:

  • woman under age 40 years all
  • woman at evaluation before beginning of fertility treatment
  • woman with regular menstrual cycle

Exclusion Criteria:

  • woman who treat with ovulation induction

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Antral follicle count accuracy during the menstrual cycle for ovarian reserve evaluation.
Time Frame: Within the 28-35 days of the menstrual cycle.
Within the 28-35 days of the menstrual cycle.

Collaborators and Investigators

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

Sponsor

Meir Medical Center

Investigators

  • Study Director: Roni Tepper, professor, Meir Medical Center Israel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2013

Primary Completion (ANTICIPATED)

November 1, 2013

Study Completion (ANTICIPATED)

November 1, 2013

Study Registration Dates

First Submitted

November 23, 2011

First Submitted That Met QC Criteria

November 25, 2011

First Posted (ESTIMATE)

November 28, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

March 12, 2013

Last Update Submitted That Met QC Criteria

March 10, 2013

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMC11102-11CTLI

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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