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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
Eugonia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

First Posted
July 24, 2018
Last Updated
February 7, 2019
Sponsor
Eugonia
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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
Raine-Fenning N, Deb S, Jayaprakasan K, Clewes J, Hopkisson J, Campbell B. Timing of oocyte maturation and egg collection during controlled ovarian stimulation: a randomized controlled trial evaluating manual and automated measurements of follicle diameter. Fertil Steril. 2010 Jun;94(1):184-8. doi: 10.1016/j.fertnstert.2009.02.063. Epub 2009 Apr 1.
Results Reference
background
PubMed Identifier
20226448
Citation
Lamazou F, Arbo E, Salama S, Grynberg M, Frydman R, Fanchin R. Reliability of automated volumetric measurement of multiple growing follicles in controlled ovarian hyperstimulation. Fertil Steril. 2010 Nov;94(6):2172-6. doi: 10.1016/j.fertnstert.2010.01.062. Epub 2010 Mar 12.
Results Reference
background
PubMed Identifier
19342038
Citation
Salama S, Arbo E, Lamazou F, Levailllant JM, Frydman R, Fanchin R. Reproducibility and reliability of automated volumetric measurement of single preovulatory follicles using SonoAVC. Fertil Steril. 2010 Apr;93(6):2069-73. doi: 10.1016/j.fertnstert.2008.12.115. Epub 2009 Apr 1.
Results Reference
background
PubMed Identifier
21112951
Citation
Ata B, Seyhan A, Reinblatt SL, Shalom-Paz E, Krishnamurthy S, Tan SL. Comparison of automated and manual follicle monitoring in an unrestricted population of 100 women undergoing controlled ovarian stimulation for IVF. Hum Reprod. 2011 Jan;26(1):127-33. doi: 10.1093/humrep/deq320. Epub 2010 Nov 26.
Results Reference
background
PubMed Identifier
19376513
Citation
Rodriguez-Fuentes A, Hernandez J, Garcia-Guzman R, Chinea E, Iaconianni L, Palumbo A. Prospective evaluation of automated follicle monitoring in 58 in vitro fertilization cycles: follicular volume as a new indicator of oocyte maturity. Fertil Steril. 2010 Feb;93(2):616-20. doi: 10.1016/j.fertnstert.2009.02.058. Epub 2009 Apr 18.
Results Reference
background
PubMed Identifier
25420733
Citation
Revelli A, Martiny G, Delle Piane L, Benedetto C, Rinaudo P, Tur-Kaspa I. A critical review of bi-dimensional and three-dimensional ultrasound techniques to monitor follicle growth: do they help improving IVF outcome? Reprod Biol Endocrinol. 2014 Nov 24;12:107. doi: 10.1186/1477-7827-12-107.
Results Reference
background
PubMed Identifier
20069654
Citation
Deb S, Campbell BK, Clewes JS, Raine-Fenning NJ. Quantitative analysis of antral follicle number and size: a comparison of two-dimensional and automated three-dimensional ultrasound techniques. Ultrasound Obstet Gynecol. 2010 Mar;35(3):354-60. doi: 10.1002/uog.7505.
Results Reference
background
PubMed Identifier
18937942
Citation
Deutch TD, Joergner I, Matson DO, Oehninger S, Bocca S, Hoenigmann D, Abuhamad A. Automated assessment of ovarian follicles using a novel three-dimensional ultrasound software. Fertil Steril. 2009 Nov;92(5):1562-8. doi: 10.1016/j.fertnstert.2008.08.102. Epub 2008 Oct 19.
Results Reference
background
PubMed Identifier
25593942
Citation
Vandekerckhove F, Bracke V, De Sutter P. The Value of Automated Follicle Volume Measurements in IVF/ICSI. Front Surg. 2014 May 28;1:18. doi: 10.3389/fsurg.2014.00018. eCollection 2014.
Results Reference
background
PubMed Identifier
24130840
Citation
Pan P, Chen X, Li Y, Zhang Q, Zhao X, Bodombossou-Djobo MM, Yang D. Comparison of manual and automated measurements of monodominant follicle diameter with different follicle size in infertile patients. PLoS One. 2013 Oct 10;8(10):e77095. doi: 10.1371/journal.pone.0077095. eCollection 2013.
Results Reference
background
PubMed Identifier
18930205
Citation
Raine-Fenning N, Jayaprakasan K, Chamberlain S, Devlin L, Priddle H, Johnson I. Automated measurements of follicle diameter: a chance to standardize? Fertil Steril. 2009 Apr;91(4 Suppl):1469-72. doi: 10.1016/j.fertnstert.2008.07.1719. Epub 2008 Oct 18.
Results Reference
background
PubMed Identifier
18484679
Citation
Raine-Fenning N, Jayaprakasan K, Clewes J, Joergner I, Bonaki SD, Chamberlain S, Devlin L, Priddle H, Johnson I. SonoAVC: a novel method of automatic volume calculation. Ultrasound Obstet Gynecol. 2008 Jun;31(6):691-6. doi: 10.1002/uog.5359.
Results Reference
background
PubMed Identifier
19589513
Citation
Broekmans FJ, de Ziegler D, Howles CM, Gougeon A, Trew G, Olivennes F. The antral follicle count: practical recommendations for better standardization. Fertil Steril. 2010 Aug;94(3):1044-51. doi: 10.1016/j.fertnstert.2009.04.040. Epub 2009 Jul 8.
Results Reference
background
PubMed Identifier
17505940
Citation
Soldevila PN, Carreras O, Tur R, Coroleu B, Barri PN. Sonographic assessment of ovarian reserve. Its correlation with outcome of in vitro fertilization cycles. Gynecol Endocrinol. 2007 Apr;23(4):206-12. doi: 10.1080/09513590701253776.
Results Reference
background

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2D Versus SonoAVC Scanning in High Responders

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