Clinical trial NCT03610009: 2D Versus SonoAVC Scanning in High Responders
Official title: Manual Versus Automated Measurements of Ovarian Follicle Diameter in High Responding Patients With GnRH Agonist Triggering of Final Oocyte Maturation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: Eugonia
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Follicle development in women undergoing IVF will be monitored either by conventional 2D ultrasound or SonoAVC.
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of mature oocytes
timeFrame: Day of oocyte retrieval
Secondary outcomes:
measure: Number of oocytes retrieved
timeFrame: Day of oocyte retrieval
measure: Oocyte maturation rate
timeFrame: Day of oocyte retrieval
measure: Oocyte retrieval rate
timeFrame: Day of oocyte retrieval
measure: Number of fertilised oocytes
timeFrame: 1 day post oocyte retrieval
measure: Fertilisation rate
timeFrame: 1 day post oocyte retrieval
measure: Number of blastocysts
timeFrame: 5 days post oocyte retrieval
measure: Days of stimulation
timeFrame: 10-15 days after menses
measure: Total dose of recFSH
timeFrame: 10-15 days after menses
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Eugonia Unit of Assisted Reproduction
Study officials:
affiliation: Eugonia
name: Tryfon Lainas, PhD
role: STUDY_DIRECTOR
References:
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