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

• Conditions: Infertility

• Registration Number: NCT01480115
• Lead Sponsor: Meir Medical Center

Brief Summary

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.

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 Timeline

• Status Verified: 2011-11
• Study First Submitted: 2011-11-23
• Study First Submitted QC: 2011-11-25
• Study First Posted: 2011-11-28
• Last Update Submitted: 2013-03-10
• Last Update Posted: 2013-03-12
• Study Start: 2013-04
• Primary Completion: 2013-11
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antral follicle count accuracy during the menstrual cycle for ovarian reserve evaluation.	Within the 28-35 days of the menstrual cycle.

Trial Locations

Locations (1)

Fertility unit, Meir Medical Center, Israel; 🇮🇱 Kfar Saba, Israel