Infertility Clinical Trial
Official title:
A Randomised Control Trial of Three-dimensional Versus Two-dimensional Ultrasound Guided Embryo Transfer in Women Undergoing Artificial Reproductive Technology Treatment
NCT number | NCT02413697 |
Other study ID # | CRE-2014.650 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2015 |
Est. completion date | September 2018 |
Verified date | January 2019 |
Source | Chinese University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 481 |
Est. completion date | September 2018 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 24 Years to 42 Years |
Eligibility |
Inclusion Criteria: - Women undergoing embryo transfer in either fresh or frozen cycles. - Women whose endometrial cavity can be visualised adequately via US Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Chinese University of Hong Kong | Hong Kong | Shatin |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Alcázar JL, Iturra A, Sedda F, Aubá 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. — View Citation
Bermejo C, Martínez Ten P, Cantarero R, Diaz D, Pérez Pedregosa J, Barrón E, Labrador E, Ruiz López L. Three-dimensional ultrasound in the diagnosis of Müllerian duct anomalies and concordance with magnetic resonance imaging. Ultrasound Obstet Gynecol. 2010 May;35(5):593-601. doi: 10.1002/uog.7551. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
Jurkovic D. Three-dimensional ultrasound in gynecology: a critical evaluation. Ultrasound Obstet Gynecol. 2002 Feb;19(2):109-17. Review. — View Citation
Letterie GS. Three-dimensional ultrasound-guided embryo transfer: a preliminary study. Am J Obstet Gynecol. 2005 Jun;192(6):1983-7; discussion 1987-8. — View Citation
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. Epub 2006 Dec 5. — View Citation
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. Epub 2005 Aug 25. — View Citation
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. — 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
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. — View Citation
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. Review. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical pregnancy | Clinical pregnancy rate following ART treatment | 12 months | |
Secondary | Implantation | Implantation rate following ART treatment | 12 months | |
Secondary | Multiple pregnancy | Multiple pregnancy rate following ART treatment | 12 months | |
Secondary | Miscarriage | Miscarriage rate following ART treatment | 12 months | |
Secondary | Ectopic pregnancy | Ectopic pregnancy rate following ART treatment | 12 months |
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