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3D Ultrasound Uterine Characteristics of Women Undergoing IVF/ICSI Treatment

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ClinicalTrials.gov Identifier: NCT02549235
Recruitment Status : Recruiting
First Posted : September 15, 2015
Last Update Posted : June 4, 2019
Sponsor:
Collaborator:
Imperial College Healthcare NHS Trust
Information provided by (Responsible Party):
Sotirios Saravelos, Imperial College Healthcare NHS Trust

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.

Condition or disease Intervention/treatment
Infertility Other: Ultrasound

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 3D Ultrasound Uterine Characteristics of Women Undergoing IVF/ICSI Treatment
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • Other: Ultrasound
    Routine 2D/3D ultrasound assessment


Primary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: 28 days from embryo transfer ]
    Clinical pregnancy


Secondary Outcome Measures :
  1. Ectopic pregnancy [ Time Frame: 28 days from embryo transfer ]
    Ectopic pregnancy

  2. Ongoing pregnancy [ Time Frame: 12 weeks from embryo transfer ]
    Ongoing pregnancy

  3. Clinical miscarriage [ Time Frame: until 12 weeks of pregnancy ]
    Clinical miscarriage



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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Women with infertility undergoing IVF/ICSI at the Assisted Reproductive Technology Unit, Hammersmith Hospital, London.
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549235


Contacts
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Contact: Sotirios H Saravelos, MRCOG +44 0203313 ext 3185 s.saravelos@imperial.ac.uk
Contact: Rehan Salim, MRCOG +44 0203313 ext 3185 rehan.salim@nhs.net

Locations
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United Kingdom
IVF Unit, Hammersmith Hospital Recruiting
London, United Kingdom, W12 0HS
Contact: Sotirios Saravelos, MRCOG    +44 0203313 ext 3185    s.saravelos@imperial.ac.uk   
Contact: Kate Purugganan    +44 0203313 ext 48202    kate.purugganan@nhs.net   
Sub-Investigator: Barbara Manukian, MD         
Principal Investigator: Rehan Salim, MRCOG         
Sub-Investigator: Kate Puruggana         
Principal Investigator: Sotirios Saravelos, MRCOG         
Sponsors and Collaborators
Imperial College London
Imperial College Healthcare NHS Trust

Publications:

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Responsible Party: Sotirios Saravelos, Subspecialty Trainee in Reproductive Medicine, Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT02549235     History of Changes
Other Study ID Numbers: CT-183/2015
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sotirios Saravelos, Imperial College Healthcare NHS Trust:
IVF/ICSI
Infertility
Septate uterus
3D
Ultrasound
Arcuate uterus
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female