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

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: 3D follicles assessment; Other: 2D follicles assessment

• Registration Number: NCT01723267
• Lead Sponsor: Rabin Medical Center

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

Study Timeline

• Study First Submitted: 2012-07-12
• Study First Submitted QC: 2012-11-05
• Study First Posted: 2012-11-07
• Study Start: 2012-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-10
• Last Update Posted: 2016-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

• Age:18-39, cycle number 1-4

Exclusion Criteria

• PCOS
• Endometriosis
• Poor ovarian response
• TESA sperm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D follicles assessment	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.
2D follicles assessment	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.

Primary Outcome Measures

Name	Time	Method
percentage of matured oocytes	one IVF cycle (within two weeks)

Secondary Outcome Measures

Name	Time	Method
Fertilization rate in ICSI	one IVF cycle/ patient (within two weeks)

Trial Locations

Locations (1)

IVF Unit, Rabin Medical Center; 🇮🇱 Petach Tikva, Israel