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

NCT01480115 | Unknown DMC

• 1 other identifier: MMC11102-11CTLI
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

antral follicle count; automated antral follicle count; ovarian reserve

Outcome Measures

Primary Outcomes (1)

• Antral follicle count accuracy during the menstrual cycle for ovarian reserve evaluation.

  Within the 28-35 days of the menstrual cycle.

Interventions

ultrasound examination for AFC evaluation OTHER

Ultrasound examination three times during the menstrual cycle to measure the AFC.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• woman under age 40 years all
• woman at evaluation before beginning of fertility treatment
• woman with regular menstrual cycle

You may not qualify if:

• woman who treat with ovulation induction

Sponsors & Collaborators

• Meir Medical Center: lead

Study Sites (1)

Fertility unit, Meir Medical Center, Israel

Kfar Saba, Israel

Location

Related Publications (10)

• 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. doi: 10.1016/j.fertnstert.2004.10.011.

  PMID: 15705365 BACKGROUND

• 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.

  PMID: 17239869 BACKGROUND

• 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. doi: 10.1002/uog.5222. No abstract available.

  PMID: 18044823 BACKGROUND

• 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.

  PMID: 21183169 BACKGROUND

• 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.

  PMID: 20434151 BACKGROUND

• 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.

  PMID: 21575853 BACKGROUND

• 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.

  PMID: 21147822 BACKGROUND

• 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.

  PMID: 19212944 BACKGROUND

• 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. doi: 10.1016/j.rbmo.2009.09.008.

  PMID: 20021717 BACKGROUND

• 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. doi: 10.1016/s1472-6483(10)60010-7.

  PMID: 19549444 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and serum for FSH, LH, E2, AMH, Prolactin, TSH, Testosterone, Progesterone, 17-OHP, DHEA-S.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Roni Tepper, professor

  Meir Medical Center Israel

  STUDY DIRECTOR

Central Study Contacts

Roni Tepper, professor

CONTACT

972-9-7472871; tepper@clalit.org.il

Merav Sharvit, doctor

CONTACT

972-9-7472871; merav.sharvit@gamil.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: November 28, 2011
• Study Start: April 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: March 12, 2013

Record last verified: 2011-11

Locations

IL (1)