2D Versus SonoAVC Scanning in High Responders

Overview

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.

Full Title of Study: “Manual Versus Automated Measurements of Ovarian Follicle Diameter in High Responding Patients With GnRH Agonist Triggering of Final Oocyte Maturation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: January 31, 2019

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

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

Arms, Groups and Cohorts

  • 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.
  • Active Comparator: SonoAVC
    • SonoAVC is used to identify number and size of ovarian follicles, to select optimal day for triggering final oocyte maturation.

Clinical Trial Outcome Measures

Primary Measures

  • Number of mature oocytes
    • Time Frame: Day of oocyte retrieval
    • The number of mature (metaphase-II) oocytes retrieved

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Eugonia
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tryfon Lainas, PhD, Study Director, Eugonia

References

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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.

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.

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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.

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.

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.

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.

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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.

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