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2D Versus SonoAVC Scanning in High Responders

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03610009
Enrollment
52
Registered
2018-08-01
Start date
2018-08-01
Completion date
2019-09-30
Last updated
2019-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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.

Interventions

The timing of final follicle maturation and oocyte retrieval based on follicle tracking with use of conventional two-dimensional (2D) ultrasound.

DEVICESonoAVC

The timing of final follicle maturation and oocyte retrieval based on follicle tracking with use of SonoAVC.

Sponsors

Eugonia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Women (patients), clinician performing oocyte retrieval and clinical embryologist will be blinded to the method used for monitoring follicle development

Intervention model description

Follicle development in women undergoing IVF will be monitored either by conventional 2D ultrasound or SonoAVC.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of mature oocytesDay of oocyte retrievalThe number of mature (metaphase-II) oocytes retrieved

Secondary

MeasureTime frameDescription
Oocyte maturation rateDay of oocyte retrievalPercentage of mature oocytes/total number of oocytes
Oocyte retrieval rateDay of oocyte retrievalPercentage of oocyte retrieved/number of follicles aspirated
Number of fertilised oocytes1 day post oocyte retrievalNumber of fertilised oocytes displaying 2 pronuclei and 2 polar bodies
Number of oocytes retrievedDay of oocyte retrievalTotal number of oocytes retrieved
Number of blastocysts5 days post oocyte retrievalNumber of embryos reaching the blastocyst stage
Days of stimulation10-15 days after mensesNumber of days recFSH is administered
Total dose of recFSH10-15 days after mensesTotal dose of recFSH administered during the ovarian stimulation period
Fertilisation rate1 day post oocyte retrievalPercentage fertilised oocytes/oocytes inseminated

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026