2D Versus SonoAVC Scanning in High Responders

NCT03610009 | Unknown

• 1 other identifier: SonoAVC
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Number of mature oocytes

  The number of mature (metaphase-II) oocytes retrieved

  Day of oocyte retrieval

Secondary Outcomes (8)

• Number of oocytes retrieved

  Day of oocyte retrieval

• Oocyte maturation rate

  Day of oocyte retrieval

• Oocyte retrieval rate

  Day of oocyte retrieval

• Number of fertilised oocytes

  1 day post oocyte retrieval

• Fertilisation rate

  1 day post oocyte retrieval

Study Arms (2)

2D ultrasound

ACTIVE COMPARATOR

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

SonoAVC

ACTIVE COMPARATOR

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

Device: SonoAVC

Interventions

2D ultrasound DEVICE

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

2D ultrasound

SonoAVC DEVICE

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

SonoAVC

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• poor responders
• hCG injection to trigger final oocyte maturation

Sponsors & Collaborators

• Eugonia: lead

Study Sites (1)

Eugonia Unit of Assisted Reproduction

Athens, 11528, Greece

Location

Related Publications (14)

• 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.

  PMID: 19342014 BACKGROUND

• 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.

  PMID: 20226448 BACKGROUND

• 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.

  PMID: 19342038 BACKGROUND

• 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.

  PMID: 21112951 BACKGROUND

• 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.

  PMID: 19376513 BACKGROUND

• 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.

  PMID: 25420733 BACKGROUND

• 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.

  PMID: 20069654 BACKGROUND

• 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.

  PMID: 18937942 BACKGROUND

• 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.

  PMID: 25593942 BACKGROUND

• 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.

  PMID: 24130840 BACKGROUND

• 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.

  PMID: 18930205 BACKGROUND

• 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.

  PMID: 18484679 BACKGROUND

• 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.

  PMID: 19589513 BACKGROUND

• 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.

  PMID: 17505940 BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Tryfon Lainas, PhD

  Eugonia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Women (patients), clinician performing oocyte retrieval and clinical embryologist will be blinded to the method used for monitoring follicle development
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 24, 2018
• First Posted: August 1, 2018
• Study Start: August 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: September 30, 2019
• Last Updated: February 8, 2019

Record last verified: 2019-02

Locations

GR (1)