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Ultrasound Study by Texturization as a Predictor of Pregnancy in Oocyte Donation Programs (TEXTUGEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03507322
Recruitment Status : Withdrawn (Clinic management decided to cancel the study for priority reasons)
First Posted : April 25, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
IVI Sevilla

Study Description
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Brief Summary:
This study is focused on analysing the application of ultrasound scanning techniques as new biomarkers in reproductive medicine. Those biomarkers are based on the analysis of ultrasound texture in different areas of uterine tissue, using 2D/3D ultrasound scanning. Investigators will use the algorithm Text® to analyse the ultrasound texture of the endometrium and myometrium. The aim of the project is to study if it is possible to obtain measurable, objective and reproducible data in healthy volunteers which can be used to predict pregnancy and determine the best moment to perform embryo transfer in assisted reproductive technology (ART) cycles

Condition or disease Intervention/treatment
Infertility Other: Ultrasound texturization

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound Study Through Uterine Texturization to Predict Pregnancy After Blastocyst Transfer in Patients Undergoing Hormone Replacement Therapy (HRT) Cycles With Donor Oocytes
Actual Study Start Date : November 7, 2017
Actual Primary Completion Date : September 10, 2018
Actual Study Completion Date : September 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Ultrasound texturization
Application of ultrasound texturization (2D/3D ultrasound scanning)
 Other: Ultrasound texturization
Along several visits to the clinic, the patients will be subjected to 2D/3D ultrasound scanning.


Outcome Measures
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Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: Around 5-6 weeks after embryo transfer ]
    Detection of gestational sac through ultrasound scanning indicating clinical pregnancy

  2. Biochemical miscarriage rate [ Time Frame: Up to one month after embryo transfer ]
    Interruption of pregnancy after a positive result in the beta HCG test

  3. Clinical miscarriage rate [ Time Frame: Up to 20 weeks after embryo transfer ]
    Interruption of pregnancy after confirming clinical pregnancy using ultrasound scanning

  4. Chemical pregnancy rate [ Time Frame: Around 14 days after embryo transfer ]
    Positive result in beta HCG test indicating pregnancy

  5. beta HCG level [ Time Frame: Around 14 days after embryo transfer ]
    Level of beta HCG in the test performed to detect pregnancy


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infertile women undergoing IVF/ICSI treatment
Criteria

Inclusion Criteria:

  • Body mass index (BMI) between 18 and 30 kg/m2
  • Not taking the contraceptive pill in a previous cycle
  • Non-pregnant: beta human chorionic gonadotropin (HCG) test with negative result at the beginning of the study)
  • No previous history of inflammatory diseases, circulatory diseases, abdomen or pelvic diseases
  • Physical gynecological exploration without pathological findings
  • Gynecological ultrasound study of the uterus with a normal result

Exclusion Criteria:

  • Ultrasound studies with technical defects in image acquisition
  • Simultaneous participation in other studies
  • Previous participation in other study which can affect the results of the present study
Contacts and Locations
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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): NCT03507322


Locations
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Spain
IVI Sevilla
Sevilla, Spain, 41011
Sponsors and Collaborators
IVI Sevilla
More Information
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Responsible Party: IVI Sevilla
ClinicalTrials.gov Identifier: NCT03507322    
Other Study ID Numbers: 1605-SEV-034-IR
First Posted: April 25, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

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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 IVI Sevilla:
texturization
pregnancy rate
oocyte donation
 2D ultrasound
3D ultrasound
assisted reproductive technology (ART)
Additional relevant MeSH terms:
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Infertility