Automated 3D (SonoAVC) Versus 2D Ovarian Follicles Assessment in IVF Cycles: a Randomized Controlled Trial

NCT ID: NCT01723267

Last Updated: 2016-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-12-31

Brief Summary

Accurate assessment of the size of follicles is important in IVF treatment.Timing of oocyte maturation and subsequent egg collection is largely based on follicle size. An accurate assessment of follicle size and appropriate timing of HCG result in retrieval of more mature oocytes, improved fertilization and higher pregnancy rates. in 3D technology- fter the capturing of a 3D image of an ovary, SonoAVC automatically analyzes the volume dataset, identifies the boundaries of hypoechoic follicles, and provides estimates of their absolute dimensions. These measurements include the largest diameters in three orthogonal planes, the mean follicular diameter (MFD), the volume of the follicle, and the volume-based diameter (d(V)) of the follicle. In the current study the investigators aim to evaluate the use of this automated technique of follicle measurement vs. standard 2D technology on the timing of oocyte maturation and subsequent oocyte retrieval. The investigators speculate that 3D assessment will increase the rate of mature oocyte collection, and eventually will improve other treatment outcomes such as fertilization rate.

Detailed Description

Not desired

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

3D follicles assessment

During IVF treatment all ultrasound examinations will use 3D- SonoAVC technology. Timing of hCG injection and oocyte collection will be based on follicle volume and 3D-volume based diameter.

Group Type: ACTIVE_COMPARATOR

3D follicles assessment

Intervention Type: OTHER

3D ultrasound evaluation in IVF treatment (vs 2D ultrasound)

2D follicles assessment

During IVF treatment all ultrasound examinations will use standard 2D ultrasound. Timing of hCG injection and oocyte collection will be based on follicle diameter.

Group Type: ACTIVE_COMPARATOR

2D follicles assessment

Intervention Type: OTHER

2D ultrasound in IVF treatment (vs 3D ultrasound)

Interventions

3D follicles assessment

3D ultrasound evaluation in IVF treatment (vs 2D ultrasound)

Intervention Type: OTHER

2D follicles assessment

2D ultrasound in IVF treatment (vs 3D ultrasound)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age:18-39, cycle number 1-4

Exclusion Criteria

• PCOS
• Endometriosis
• Poor ovarian response
• TESA sperm

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

avi ben haroush

Head of Fertility Preservation Service,IVF and Infertility Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Avi Ben-Haroush, MD

Role: PRINCIPAL_INVESTIGATOR

Rabin Medical Center

Locations

IVF Unit, Rabin Medical Center

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

rmcavibh-1

Identifier Type: -

Identifier Source: org_study_id