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Clinical Trials/NCT03610009
NCT03610009UnknownNot Applicable

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

Eugonia2 sites in 1 country52 target enrollmentStarted: August 1, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
52
Locations
2
Primary Endpoint
Number of mature oocytes

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Masking Description

Women (patients), clinician performing oocyte retrieval and clinical embryologist will be blinded to the method used for monitoring follicle development

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

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.

Intervention: 2D ultrasound (Device)

SonoAVC

Active Comparator

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

Intervention: SonoAVC (Device)

Outcomes

Primary Outcomes

Number of mature oocytes

Time Frame: Day of oocyte retrieval

The number of mature (metaphase-II) oocytes retrieved

Secondary Outcomes

  • Oocyte maturation rate(Day of oocyte retrieval)
  • Number of oocytes retrieved(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)
  • Number of blastocysts(5 days post oocyte retrieval)
  • Days of stimulation(10-15 days after menses)
  • Total dose of recFSH(10-15 days after menses)

Investigators

Sponsor
Eugonia
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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