2D Versus SonoAVC Scanning in High Responders

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03610009
• Other study ID #: SonoAVC
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: February 2019
• Source: Eugonia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 52
• Est. completion date: September 30, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
Greece	Eugonia Unit of Assisted Reproduction	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Eugonia

Country where clinical trial is conducted

Greece, 

References & Publications (14)

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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Rodríguez-Fuentes A, Hernández J, García-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. — View 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. — View 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. — View 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. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of mature oocytes	The number of mature (metaphase-II) oocytes retrieved	Day of oocyte retrieval
Secondary	Number of oocytes retrieved	Total number of oocytes retrieved	Day of oocyte retrieval
Secondary	Oocyte maturation rate	Percentage of mature oocytes/total number of oocytes	Day of oocyte retrieval
Secondary	Oocyte retrieval rate	Percentage of oocyte retrieved/number of follicles aspirated	Day of oocyte retrieval
Secondary	Number of fertilised oocytes	Number of fertilised oocytes displaying 2 pronuclei and 2 polar bodies	1 day post oocyte retrieval
Secondary	Fertilisation rate	Percentage fertilised oocytes/oocytes inseminated	1 day post oocyte retrieval
Secondary	Number of blastocysts	Number of embryos reaching the blastocyst stage	5 days post oocyte retrieval
Secondary	Days of stimulation	Number of days recFSH is administered	10-15 days after menses
Secondary	Total dose of recFSH	Total dose of recFSH administered during the ovarian stimulation period	10-15 days after menses