2D Versus SonoAVC Scanning in High Responders

February 7, 2019 updated by: Eugonia

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11528
        • Eugonia Unit of Assisted Reproduction

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eugonia

Investigators

  • Study Director: Tryfon Lainas, PhD, Eugonia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

January 31, 2019

Study Completion (Anticipated)

September 30, 2019

Study Registration Dates

First Submitted

July 24, 2018

First Submitted That Met QC Criteria

July 24, 2018

First Posted (Actual)

August 1, 2018

Study Record Updates

Last Update Posted (Actual)

February 8, 2019

Last Update Submitted That Met QC Criteria

February 7, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SonoAVC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infertility

Clinical Trials on 2D ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Panama

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe