NCT02413697

Brief Summary

Objectives: To assess whether embryo transfer guided by three-dimensional ultrasound (3DUS) produces a significantly higher clinical pregnancy rate than embryo transfer guided by two-dimensional ultrasound (2DUS). Hypothesis: 3DUS guided embryo transfer will produce a significantly higher clinical pregnancy rate compared with 2DUS guided embryo transfer. Design and subjects: Prospective randomised control trial (RCT) at the Prince of Wales Hospital. Inclusion criteria include women undergoing embryo transfer in fresh and frozen cycles. Exclusion criteria include women aged \>42 years and women whose endometrial cavity cannot be visualised adequately via US. Power calculations indicate that 232 patients per arm are required to demonstrate an increase of 12% in clinical pregnancy rates. Study instruments: US examinations will be performed using a General Electric(GE) Voluson series US machine with a standard 3D transvaginal probe. For embryo transfer, the Cooks Guardia Access EchoTip catheter will be used. Interventions: 3D versus 2DUS for guidance during embryo transfer. Main outcome measures: clinical pregnancy. Secondary outcome measures: implantation rate, multiple pregnancy, miscarriage, ectopic pregnancy and live birth rates. Data analysis: Data processing and analysis will be performed using the Statistical Packages of Social Sciences for Windows (SPSS, Inc). Descriptive and comparative statistical methods will be used to analyse the primary outcomes. P-values of \<0.05 will be considered significant. Expected results: The study arm undergoing 3DUS guided embryo transfer are expected to have an improved clinical pregnancy rate compared with the control arm undergoing 2DUS guided embryo transfer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
481

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

1 year

First QC Date

April 4, 2015

Last Update Submit

January 29, 2019

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy

    Clinical pregnancy rate following ART treatment

    12 months

Secondary Outcomes (4)

  • Implantation

    12 months

  • Multiple pregnancy

    12 months

  • Miscarriage

    12 months

  • Ectopic pregnancy

    12 months

Study Arms (2)

Two-dimensional ultrasound

ACTIVE COMPARATOR

Two-dimensional ultrasound guided embryo transfer

Device: Two-dimensional ultrasound

Three-dimensional ultrasound

EXPERIMENTAL

Three-dimensional ultrasound guided embryo transfer

Device: Three-dimensional ultrasound

Interventions

Two-dimensional ultrasoundDEVICE

Two-dimensional ultrasound guided embryo transfer

Two-dimensional ultrasound
Three-dimensional ultrasoundDEVICE

Three-dimensional ultrasound guided embryo transfer

Three-dimensional ultrasound

Eligibility Criteria

Age24 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women undergoing embryo transfer in either fresh or frozen cycles.
  • Women whose endometrial cavity can be visualised adequately via US

You may not qualify if:

  • Women aged \>42 years
  • Women whose endometrial cavity cannot be visualised adequately via US, such as large fibroids, adenomyosis, BMI\>35, significant uterine retroflexion/retroversion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Shatin, Hong Kong

Location

Related Publications (15)

  • Alcazar JL, Iturra A, Sedda F, Auba M, Ajossa S, Guerriero S, Jurado M. Three-dimensional volume off-line analysis as compared to real-time ultrasound for assessing adnexal masses. Eur J Obstet Gynecol Reprod Biol. 2012 Mar;161(1):92-5. doi: 10.1016/j.ejogrb.2011.12.002. Epub 2011 Dec 22.

    PMID: 22197306BACKGROUND

  • Bermejo C, Martinez Ten P, Cantarero R, Diaz D, Perez Pedregosa J, Barron E, Labrador E, Ruiz Lopez L. Three-dimensional ultrasound in the diagnosis of Mullerian duct anomalies and concordance with magnetic resonance imaging. Ultrasound Obstet Gynecol. 2010 May;35(5):593-601. doi: 10.1002/uog.7551.

    PMID: 20052665BACKGROUND

  • Saravelos SH, Cocksedge KA, Li TC. Prevalence and diagnosis of congenital uterine anomalies in women with reproductive failure: a critical appraisal. Hum Reprod Update. 2008 Sep-Oct;14(5):415-29. doi: 10.1093/humupd/dmn018. Epub 2008 Jun 6.

    PMID: 18539641BACKGROUND

  • Raine-Fenning N, Jayaprakasan K, Deb S, Clewes J, Joergner I, Dehghani Bonaki S, Johnson I. Automated follicle tracking improves measurement reliability in patients undergoing ovarian stimulation. Reprod Biomed Online. 2009 May;18(5):658-63. doi: 10.1016/s1472-6483(10)60010-7.

    PMID: 19549444BACKGROUND

  • 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: 18930205BACKGROUND

  • Raine-Fenning N, Fleischer AC. Clarifying the role of three-dimensional transvaginal sonography in reproductive medicine: an evidenced-based appraisal. J Exp Clin Assist Reprod. 2005 Aug 11;2:10. doi: 10.1186/1743-1050-2-10.

    PMID: 16095530BACKGROUND

  • Coyne L, Jayaprakasan K, Raine-Fenning N. 3D ultrasound in gynecology and reproductive medicine. Womens Health (Lond). 2008 Sep;4(5):501-16. doi: 10.2217/17455057.4.5.501.

    PMID: 19072489BACKGROUND

  • Jurkovic D. Three-dimensional ultrasound in gynecology: a critical evaluation. Ultrasound Obstet Gynecol. 2002 Feb;19(2):109-17. doi: 10.1046/j.0960-7692.2001.00654.x. No abstract available.

    PMID: 11876800BACKGROUND

  • 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: 18484679BACKGROUND

  • Ng EH, Chan CC, Tang OS, Yeung WS, Ho PC. The role of endometrial and subendometrial blood flows measured by three-dimensional power Doppler ultrasound in the prediction of pregnancy during IVF treatment. Hum Reprod. 2006 Jan;21(1):164-70. doi: 10.1093/humrep/dei277. Epub 2005 Aug 25.

    PMID: 16123083BACKGROUND

  • Ng EH, Chan CC, Tang OS, Yeung WS, Ho PC. Endometrial and subendometrial vascularity is higher in pregnant patients with livebirth following ART than in those who suffer a miscarriage. Hum Reprod. 2007 Apr;22(4):1134-41. doi: 10.1093/humrep/del458. Epub 2006 Dec 5.

    PMID: 17148577BACKGROUND

  • Gergely RZ, DeUgarte CM, Danzer H, Surrey M, Hill D, DeCherney AH. Three dimensional/four dimensional ultrasound-guided embryo transfer using the maximal implantation potential point. Fertil Steril. 2005 Aug;84(2):500-3. doi: 10.1016/j.fertnstert.2005.01.141.

    PMID: 16084896BACKGROUND

  • Fang L, Sun Y, Su Y, Guo Y. Advantages of 3-dimensional sonography in embryo transfer. J Ultrasound Med. 2009 May;28(5):573-8. doi: 10.7863/jum.2009.28.5.573.

    PMID: 19389895BACKGROUND

  • Letterie GS. Three-dimensional ultrasound-guided embryo transfer: a preliminary study. Am J Obstet Gynecol. 2005 Jun;192(6):1983-7; discussion 1987-8. doi: 10.1016/j.ajog.2005.02.044.

    PMID: 15970868BACKGROUND

  • Saravelos SH, Kong GW, Chung JP, Mak JS, Chung CH, Cheung LP, Li TC. A prospective randomized controlled trial of 3D versus 2D ultrasound-guided embryo transfer in women undergoing ART treatment. Hum Reprod. 2016 Oct;31(10):2255-60. doi: 10.1093/humrep/dew206. Epub 2016 Sep 2.

    PMID: 27591231DERIVED

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Sotirios Saravelos, MBBS

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 4, 2015

First Posted

April 10, 2015

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

September 1, 2018

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations

HK(1)