A New Tool for Automatic Ovarian Follicle Count and it Abilities to Evaluate Ovarian Reserve
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|ClinicalTrials.gov Identifier: NCT01480115|
Recruitment Status : Unknown
Verified November 2011 by Meir Medical Center.
Recruitment status was: Not yet recruiting
First Posted : November 28, 2011
Last Update Posted : March 12, 2013
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 or disease||Intervention/treatment|
|Infertility||Other: ultrasound examination for AFC evaluation|
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|
|Estimated Enrollment :||50 participants|
|Official Title:||A New Tool for Automatic Ovarian Follicle Count and it Abilities to Evaluate Ovarian Reserve|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||November 2013|
|Estimated Study Completion Date :||November 2013|
- Other: ultrasound examination for AFC evaluation
Ultrasound examination three times during the menstrual cycle to measure the AFC.
- 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
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
|Contact: Roni Tepper, email@example.com|
|Contact: Merav Sharvit, firstname.lastname@example.org|
|Fertility unit, Meir Medical Center, Israel|
|Kfar Saba, Israel|
|Study Director:||Roni Tepper, professor||Meir Medical Center Israel|