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

NCT01723267 | Completed

• 1 other identifier: rmcavibh-1
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Keywords

IVF; 3D ultrasound; SonoAVC; patients in IVF treatment

Outcome Measures

Primary Outcomes (1)

• percentage of matured oocytes

  one IVF cycle (within two weeks)

Secondary Outcomes (1)

• Fertilization rate in ICSI

  one IVF cycle/ patient (within two weeks)

Study Arms (2)

3D follicles assessment

ACTIVE COMPARATOR

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.

Other: 3D follicles assessment

2D follicles assessment

ACTIVE COMPARATOR

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

Other: 2D follicles assessment

Interventions

3D follicles assessment OTHER

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

3D follicles assessment

2D follicles assessment OTHER

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

2D follicles assessment

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age:18-39, cycle number 1-4

You may not qualify if:

• PCOS
• Endometriosis
• Poor ovarian response
• TESA sperm

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

IVF Unit, Rabin Medical Center

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Avi Ben-Haroush, MD

  Rabin Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Fertility Preservation Service,IVF and Infertility Unit

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: November 7, 2012
• Study Start: December 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 12, 2016

Record last verified: 2016-04

Locations

IL (1)