2D Versus SonoAVC Scanning in High Responders
Primary Purpose
Infertility
Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
2D ultrasound
SonoAVC
Sponsored by
About this trial
This is an interventional other trial for Infertility
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
Sites / Locations
- Eugonia Unit of Assisted Reproduction
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
2D ultrasound
SonoAVC
Arm Description
Two-dimensional (2D) ultrasound is used to identify number and size of ovarian follicles, to select optimal day for triggering final oocyte maturation.
SonoAVC is used to identify number and size of ovarian follicles, to select optimal day for triggering final oocyte maturation.
Outcomes
Primary Outcome Measures
Number of mature oocytes
The number of mature (metaphase-II) oocytes retrieved
Secondary Outcome Measures
Number of oocytes retrieved
Total number of oocytes retrieved
Oocyte maturation rate
Percentage of mature oocytes/total number of oocytes
Oocyte retrieval rate
Percentage of oocyte retrieved/number of follicles aspirated
Number of fertilised oocytes
Number of fertilised oocytes displaying 2 pronuclei and 2 polar bodies
Fertilisation rate
Percentage fertilised oocytes/oocytes inseminated
Number of blastocysts
Number of embryos reaching the blastocyst stage
Days of stimulation
Number of days recFSH is administered
Total dose of recFSH
Total dose of recFSH administered during the ovarian stimulation period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03610009
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
September 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eugonia
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Follicle development in women undergoing IVF will be monitored either by conventional 2D ultrasound or SonoAVC.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Women (patients), clinician performing oocyte retrieval and clinical embryologist will be blinded to the method used for monitoring follicle development
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2D ultrasound
Arm Type
Active Comparator
Arm Description
Two-dimensional (2D) ultrasound is used to identify number and size of ovarian follicles, to select optimal day for triggering final oocyte maturation.
Arm Title
SonoAVC
Arm Type
Active Comparator
Arm Description
SonoAVC is used to identify number and size of ovarian follicles, to select optimal day for triggering final oocyte maturation.
Intervention Type
Device
Intervention Name(s)
2D ultrasound
Intervention Description
The timing of final follicle maturation and oocyte retrieval based on follicle tracking with use of conventional two-dimensional (2D) ultrasound.
Intervention Type
Device
Intervention Name(s)
SonoAVC
Intervention Description
The timing of final follicle maturation and oocyte retrieval based on follicle tracking with use of SonoAVC.
Primary Outcome Measure Information:
Title
Number of mature oocytes
Description
The number of mature (metaphase-II) oocytes retrieved
Time Frame
Day of oocyte retrieval
Secondary Outcome Measure Information:
Title
Number of oocytes retrieved
Description
Total number of oocytes retrieved
Time Frame
Day of oocyte retrieval
Title
Oocyte maturation rate
Description
Percentage of mature oocytes/total number of oocytes
Time Frame
Day of oocyte retrieval
Title
Oocyte retrieval rate
Description
Percentage of oocyte retrieved/number of follicles aspirated
Time Frame
Day of oocyte retrieval
Title
Number of fertilised oocytes
Description
Number of fertilised oocytes displaying 2 pronuclei and 2 polar bodies
Time Frame
1 day post oocyte retrieval
Title
Fertilisation rate
Description
Percentage fertilised oocytes/oocytes inseminated
Time Frame
1 day post oocyte retrieval
Title
Number of blastocysts
Description
Number of embryos reaching the blastocyst stage
Time Frame
5 days post oocyte retrieval
Title
Days of stimulation
Description
Number of days recFSH is administered
Time Frame
10-15 days after menses
Title
Total dose of recFSH
Description
Total dose of recFSH administered during the ovarian stimulation period
Time Frame
10-15 days after menses
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tryfon Lainas, PhD
Organizational Affiliation
Eugonia
Official's Role
Study Director
Facility Information:
Facility Name
Eugonia Unit of Assisted Reproduction
City
Athens
ZIP/Postal Code
11528
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
19342014
Citation
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Citation
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PubMed Identifier
19342038
Citation
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PubMed Identifier
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Citation
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Citation
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2D Versus SonoAVC Scanning in High Responders
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