A New Tool for Automatic Ovarian Follicle Count and it Ab... | NCT01480115

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

NCT01480115

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Mar 12, 2013Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Infertility

Interventions

ultrasound examination for AFC evaluation

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Nov 2013Estimated

Completion Date

Nov 2013Estimated

First Submitted Date

Nov 23, 2011

First Submission Date that Met QC Criteria

Nov 25, 2011

First Posted Date

Nov 28, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2013

Last Update Posted Date

Mar 12, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound examination for AFC evaluation	Other	Ultrasound examination three times during the menstrual cycle to measure the AFC.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Roni Tepper, professor	Contact	972-9-7472871		tepper@clalit.org.il
Merav Sharvit, doctor	Contact	972-9-7472871		merav.sharvit@gamil.com

Overall Officials

Name	Affiliation	Role
Roni Tepper, professor	Meir Medical Center Israel	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fertility unit, Meir Medical Center, Israel		Kfar Saba			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15705365	Background	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.
17239869

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases