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

Vida Recoletas Sevilla

Overview

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

Study Type

OBSERVATIONAL

Conditions

Infertility

Interventions

Ultrasound texturizationOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 Years

Medical Language ↔ Plain English

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

Locations (1)

IVI Sevilla

Seville, Spain

Outcomes

Primary Outcomes

Clinical pregnancy rate

Detection of gestational sac through ultrasound scanning indicating clinical pregnancy

Time frame: Around 5-6 weeks after embryo transfer

Biochemical miscarriage rate

Interruption of pregnancy after a positive result in the beta HCG test

Time frame: Up to one month after embryo transfer

Clinical miscarriage rate

Interruption of pregnancy after confirming clinical pregnancy using ultrasound scanning

Time frame: Up to 20 weeks after embryo transfer

Chemical pregnancy rate

Positive result in beta HCG test indicating pregnancy

Time frame: Around 14 days after embryo transfer

beta HCG level

Level of beta HCG in the test performed to detect pregnancy

Time frame: Around 14 days after embryo transfer

Data from ClinicalTrials.gov

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