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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01480115
First Posted: November 28, 2011
Last Update Posted: March 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meir Medical Center
  Purpose

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.


Condition Intervention
Infertility Other: ultrasound examination for AFC evaluation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A New Tool for Automatic Ovarian Follicle Count and it Abilities to Evaluate Ovarian Reserve

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Antral follicle count accuracy during the menstrual cycle for ovarian reserve evaluation. [ Time Frame: Within the 28-35 days of the menstrual cycle. ]

Biospecimen Retention:   Samples With DNA
Whole blood and serum for FSH, LH, E2, AMH, Prolactin, TSH, Testosterone, Progesterone, 17-OHP, DHEA-S.

Estimated Enrollment: 50
Study Start Date: April 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: ultrasound examination for AFC evaluation
    Ultrasound examination three times during the menstrual cycle to measure the AFC.
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01480115


Contacts
Contact: Roni Tepper, professor 972-9-7472871 tepper@clalit.org.il
Contact: Merav Sharvit, doctor 972-9-7472871 merav.sharvit@gamil.com

Locations
Israel
Fertility unit, Meir Medical Center, Israel
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Study Director: Roni Tepper, professor Meir Medical Center Israel
  More Information

Publications:

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01480115     History of Changes
Other Study ID Numbers: MMC11102-11CTLI
First Submitted: November 23, 2011
First Posted: November 28, 2011
Last Update Posted: March 12, 2013
Last Verified: November 2011

Keywords provided by Meir Medical Center:
antral follicle count
automated antral follicle count
ovarian reserve

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female