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

NCT ID: NCT03507322

Last Updated: 2018-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-07

Study Completion Date

2018-09-10

Brief Summary

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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

Detailed Description

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Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ultrasound texturization

Application of ultrasound texturization (2D/3D ultrasound scanning)

Ultrasound texturization

Intervention Type OTHER

Along several visits to the clinic, the patients will be subjected to 2D/3D ultrasound scanning.

Interventions

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Ultrasound texturization

Along several visits to the clinic, the patients will be subjected to 2D/3D ultrasound scanning.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Vida Recoletas Sevilla

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IVI Sevilla

Seville, , Spain

Site Status

Countries

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Spain

Other Identifiers

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1605-SEV-034-IR

Identifier Type: -

Identifier Source: org_study_id

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