Clinical trial NCT01480115: A New Tool for Automatic Ovarian Follicle Count and it Abilities to Evaluate Ovarian Reserve
Official title: A New Tool for Automatic Ovarian Follicle Count and it Abilities to Evaluate Ovarian Reserve
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Keywords: antral follicle count
automated antral follicle count
ovarian reserve
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-11-28
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

Eligibility 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

Primary outcomes:
measure: Antral follicle count accuracy during the menstrual cycle for ovarian reserve evaluation.
timeFrame: Within the 28-35 days of the menstrual cycle.
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Fertility unit, Meir Medical Center, Israel
Study officials:
affiliation: Meir Medical Center Israel
name: Roni Tepper, professor
role: STUDY_DIRECTOR
References:
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citation: Hendriks DJ, Kwee J, Mol BW, te Velde ER, Broekmans FJ. Ultrasonography as a tool for the prediction of outcome in IVF patients: a comparative meta-analysis of ovarian volume and antral follicle count. Fertil Steril. 2007 Apr;87(4):764-75. doi: 10.1016/j.fertnstert.2006.11.006. Epub 2007 Jan 18.
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citation: Deb S, Jayaprakasan K, Campbell BK, Clewes JS, Johnson IR, Raine-Fenning NJ. Intraobserver and interobserver reliability of automated antral follicle counts made using three-dimensional ultrasound and SonoAVC. Ultrasound Obstet Gynecol. 2009 Apr;33(4):477-83. doi: 10.1002/uog.6310.
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