2D Versus SonoAVC Scanning in High Responders

Study Overview
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Brief Summary
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Accurate follicular monitoring of Controlled Ovarian Stimulation by transvaginal ultrasound is considered important for the success of human in vitro fertilization (IVF). The aim of this study is to evaluate the effect of timing oocyte maturation and egg collection on the basis of follicular measurements made automatically with Sono Automated Volume Calculation (SonoAVC) against those made with conventional 2D ultrasound in relation to the number of mature oocytes collected. This study will take place in women undergoing IVF who are high responders (>=14 follicles>=11mm) and hence at risk for developing ovarian hyperstimulation syndrome (OHSS), treated with a GnRH antagonist protocol and administered GnRH agonist to trigger final oocyte maturation.

Detailed Description
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Accurate follicular monitoring of Controlled Ovarian Stimulation by transvaginal ultrasound is considered important for the success of human in vitro fertilization (IVF). Accurate assessment of the size of follicles is important for the timing of oocyte maturation and subsequent oocyte retrieval. Serial assessment of follicle number and size is used routinely to assess the response to ovarian stimulation during assisted reproduction treatment (ART). Two-dimensional (2D) ultrasound is used to identify and scroll through each ovary while the observer quantifies the number of follicles present. An objective assessment of the size of the larger follicles, commonly those measuring >10 mm, is then made through a series of 2D measurements of their perceived mean diameter. Sono Automated Volume Calculation (SonoAVC; GE Medical Systems) is a new software program that can be applied to datasets acquired with use of threedimensional (3D) ultrasound. It individually identifies and quantifies the size of any hypoechoic region within these 3D datasets, providing an automatic estimation of their absolute dimensions and volume. SonoAVC is an ideal and, potentially, a clinically important tool for the assessment and measurement of follicles during controlled ovarian stimulation because each hypoechoic area is individually color coded, thereby eliminating the possibility of measuring the same follicle more than once. In women with high ovarian response to gonadotrophin stimulation, the accurate measurement of the number and size of follicles present in hyperstimulated ovaries is a challenge for clinicians and ultrasonographers. The aim of this study is to evaluate the effect of timing final oocyte maturation trigger and egg collection on the basis of follicular measurements made automatically with SonoAVC against those made with conventional 2D ultrasound in relation to the number of mature oocytes collected. This study will include women undergoing ART who are high responders (presence of =>14 follicles>=11mm) and hence at risk for developing ovarian hyperstimulation syndrome (OHSS), treated with a GnRH antagonist protocol and are administered GnRH agonist to trigger final oocyte maturation. All resulting embryos (blastocysts) will be cryopreserved and transferred in a subsequent frozen cycle.

Official Title
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Manual Versus Automated Measurements of Ovarian Follicle Diameter in High Responding Patients With GnRH Agonist Triggering of Final Oocyte Maturation

Conditions
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Infertility

Intervention / Treatment
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* Device: 2D ultrasound
* Device: SonoAVC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AMH >= 3ng/ml at least 14 follicles =>11 mm diameter on final day of stimulation undergoing GnRH antagonist protocol administered GnRH agonist to trigger final oocyte maturation Exclusion Criteria: poor responders hCG injection to trigger final oocyte maturation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Follicle development in women undergoing IVF will be monitored either by conventional 2D ultrasound or SonoAVC.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2D ultrasound<br>Two-dimensional (2D) ultrasound is used to identify number and size of ovarian follicles, to select optimal day for triggering final oocyte maturation. | Device: 2D ultrasound<br>* The timing of final follicle maturation and oocyte retrieval based on follicle tracking with use of conventional two-dimensional (2D) ultrasound.<br>|
| Active Comparator: SonoAVC<br>SonoAVC is used to identify number and size of ovarian follicles, to select optimal day for triggering final oocyte maturation. | Device: SonoAVC<br>* The timing of final follicle maturation and oocyte retrieval based on follicle tracking with use of SonoAVC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of mature oocytes | The number of mature (metaphase-II) oocytes retrieved | Day of oocyte retrieval | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of oocytes retrieved | Total number of oocytes retrieved | Day of oocyte retrieval | 
| Oocyte maturation rate | Percentage of mature oocytes/total number of oocytes | Day of oocyte retrieval | 
| Oocyte retrieval rate | Percentage of oocyte retrieved/number of follicles aspirated | Day of oocyte retrieval | 
| Number of fertilised oocytes | Number of fertilised oocytes displaying 2 pronuclei and 2 polar bodies | 1 day post oocyte retrieval | 
| Fertilisation rate | Percentage fertilised oocytes/oocytes inseminated | 1 day post oocyte retrieval | 
| Number of blastocysts | Number of embryos reaching the blastocyst stage | 5 days post oocyte retrieval | 
| Days of stimulation | Number of days recFSH is administered | 10-15 days after menses | 
| Total dose of recFSH | Total dose of recFSH administered during the ovarian stimulation period | 10-15 days after menses |