NCT02549235

Brief Summary

The purpose of this trial is to evaluate the morphological characteristics of the uterus with three-dimensional ultrasound (3DUS) at the time of IVF/ICSI treatment and correlate it to clinical outcomes. The uterus will be assessed in the 3D coronal plane and measurements will be performed to assess whether they correlate with clinical pregnancy rate, miscarriage rate and live birth rate.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
3.6 years until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

June 4, 2019

Status Verified

June 1, 2019

Enrollment Period

11 months

First QC Date

September 11, 2015

Last Update Submit

June 1, 2019

Conditions

Infertility

Keywords

IVF/ICSIInfertilitySeptate uterus3DUltrasoundArcuate uterus

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy

    Clinical pregnancy

    28 days from embryo transfer

Secondary Outcomes (3)

  • Ectopic pregnancy

    28 days from embryo transfer

  • Ongoing pregnancy

    12 weeks from embryo transfer

  • Clinical miscarriage

    until 12 weeks of pregnancy

Interventions

UltrasoundOTHER

Routine 2D/3D ultrasound assessment

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women with infertility undergoing IVF/ICSI at the Assisted Reproductive Technology Unit, Hammersmith Hospital, London.

You may qualify if:

  • Women undergoing IVF/ICSI 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
  • Previous uterine surgery (e.g. septum resection, adhesiolysis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVF Unit, Hammersmith Hospital

London, W12 0HS, United Kingdom

RECRUITING

Related Publications (7)

  • 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

  • Chan YY, Jayaprakasan K, Tan A, Thornton JG, Coomarasamy A, Raine-Fenning NJ. Reproductive outcomes in women with congenital uterine anomalies: a systematic review. Ultrasound Obstet Gynecol. 2011 Oct;38(4):371-82. doi: 10.1002/uog.10056.

    PMID: 21830244BACKGROUND

  • Ludwin A, Ludwin I. Comparison of the ESHRE-ESGE and ASRM classifications of Mullerian duct anomalies in everyday practice. Hum Reprod. 2015 Mar;30(3):569-80. doi: 10.1093/humrep/deu344. Epub 2014 Dec 22.

    PMID: 25534461BACKGROUND

  • Venetis CA, Papadopoulos SP, Campo R, Gordts S, Tarlatzis BC, Grimbizis GF. Clinical implications of congenital uterine anomalies: a meta-analysis of comparative studies. Reprod Biomed Online. 2014 Dec;29(6):665-83. doi: 10.1016/j.rbmo.2014.09.006. Epub 2014 Sep 21.

    PMID: 25444500BACKGROUND

  • Grimbizis GF, Gordts S, Di Spiezio Sardo A, Brucker S, De Angelis C, Gergolet M, Li TC, Tanos V, Brolmann H, Gianaroli L, Campo R. The ESHRE/ESGE consensus on the classification of female genital tract congenital anomalies. Hum Reprod. 2013 Aug;28(8):2032-44. doi: 10.1093/humrep/det098. Epub 2013 Jun 14.

    PMID: 23771171BACKGROUND

  • Homer HA, Li TC, Cooke ID. The septate uterus: a review of management and reproductive outcome. Fertil Steril. 2000 Jan;73(1):1-14. doi: 10.1016/s0015-0282(99)00480-x.

    PMID: 10632403BACKGROUND

  • Surrey ES, Katz-Jaffe M, Surrey RL, Small AS, Gustofson RL, Schoolcraft WB. Arcuate uterus: is there an impact on in vitro fertilization outcomes after euploid embryo transfer? Fertil Steril. 2018 Apr;109(4):638-643. doi: 10.1016/j.fertnstert.2017.12.001. Epub 2018 Mar 30.

    PMID: 29609956BACKGROUND

MeSH Terms

Conditions

InfertilitySeptate Uterus

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesUterine Duplication AnomaliesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Central Study Contacts

Sotirios H Saravelos, MRCOG

CONTACT

+44 0203313s.saravelos@imperial.ac.uk

Rehan Salim, MRCOG

CONTACT

+44 0203313rehan.salim@nhs.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Subspecialty Trainee in Reproductive Medicine

Study Record Dates

First Submitted

September 11, 2015

First Posted

September 15, 2015

Study Start

May 1, 2019

Primary Completion

March 31, 2020

Study Completion

September 30, 2020

Last Updated

June 4, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)