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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01480115
• Other study ID #: MMC11102-11CTLI
• Status: Not yet recruiting
• Phase: N/A
• First received: November 23, 2011
• Last updated: March 10, 2013
• Start date: April 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2011
• Source: Meir Medical Center
• Contact: Roni Tepper, professor
• Phone: 972-9-7472871
• Email: tepper[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Clalit Health Services
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• ultrasound examination for AFC evaluation
Ultrasound examination three times during the menstrual cycle to measure the AFC.

Locations

Country	Name	City	State
Israel	Fertility unit, Meir Medical Center, Israel	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (10)

Al-Azemi M, Killick SR, Duffy S, Pye C, Refaat B, Hill N, Ledger W. Multi-marker assessment of ovarian reserve predicts oocyte yield after ovulation induction. Hum Reprod. 2011 Feb;26(2):414-22. doi: 10.1093/humrep/deq339. Epub 2010 Dec 8. — View 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. — View 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. Epub 2007 Jan 18. — View Citation

Hendriks DJ, Mol BW, Bancsi LF, Te Velde ER, Broekmans FJ. Antral follicle count in the prediction of poor ovarian response and pregnancy after in vitro fertilization: a meta-analysis and comparison with basal follicle-stimulating hormone level. Fertil Steril. 2005 Feb;83(2):291-301. — View Citation

Hsu A, Arny M, Knee AB, Bell C, Cook E, Novak AL, Grow DR. Antral follicle count in clinical practice: analyzing clinical relevance. Fertil Steril. 2011 Feb;95(2):474-9. doi: 10.1016/j.fertnstert.2010.03.023. — View Citation

Murtinger M, Aburumieh A, Rubner P, Eichel V, Zech MH, Zech NH. Improved monitoring of ovarian stimulation using 3D transvaginal ultrasound plus automated volume count. Reprod Biomed Online. 2009 Nov;19(5):695-9. — View Citation

Olivennes F, Howies CM, Borini A, Germond M, Trew G, Wikland M, Zegers-Hochschild F, Saunders H, Alam V. Individualizing FSH dose for assisted reproduction using a novel algorithm: the CONSORT study. Reprod Biomed Online. 2011 Feb;22 Suppl 1:S73-82. doi: 10.1016/S1472-6483(11)60012-6. — View Citation

Raine-Fenning N, Jayaprakasan K, Clewes J. Automated follicle tracking facilitates standardization and may improve work flow. Ultrasound Obstet Gynecol. 2007 Dec;30(7):1015-8. — View Citation

Raine-Fenning N, Jayaprakasan K, Deb S, Clewes J, Joergner I, Dehghani Bonaki S, Johnson I. Automated follicle tracking improves measurement reliability in patients undergoing ovarian stimulation. Reprod Biomed Online. 2009 May;18(5):658-63. — View Citation

Styer AK, Toth TL. Antral follicle count in clinical practice: building the bridge from ovarian reserve to in vitro fertilization outcome. Fertil Steril. 2011 Feb;95(2):480-1; discussion 484-5. doi: 10.1016/j.fertnstert.2010.11.054. Epub 2010 Dec 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antral follicle count accuracy during the menstrual cycle for ovarian reserve evaluation.		Within the 28-35 days of the menstrual cycle.	No