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

Withdrawn

• Conditions: Infertility
• Interventions: Other: Ultrasound texturization

• Registration Number: NCT03507322
• Lead Sponsor: IVI Sevilla

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-07
• Study First Submitted: 2017-11-10
• Study First Submitted QC: 2018-04-24
• Study First Posted: 2018-04-25
• Status Verified: 2018-09
• Primary Completion: 2018-09-10
• Study Completion: 2018-09-10
• Last Update Submitted: 2018-09-10
• Last Update Posted: 2018-09-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ultrasound texturization	Ultrasound texturization	Application of ultrasound texturization (2D/3D ultrasound scanning)

Primary Outcome Measures

Name	Time	Method
Chemical pregnancy rate	Around 14 days after embryo transfer	Positive result in beta HCG test indicating pregnancy
Clinical miscarriage rate	Up to 20 weeks after embryo transfer	Interruption of pregnancy after confirming clinical pregnancy using ultrasound scanning
beta HCG level	Around 14 days after embryo transfer	Level of beta HCG in the test performed to detect pregnancy
Clinical pregnancy rate	Around 5-6 weeks after embryo transfer	Detection of gestational sac through ultrasound scanning indicating clinical pregnancy
Biochemical miscarriage rate	Up to one month after embryo transfer	Interruption of pregnancy after a positive result in the beta HCG test

Trial Locations

Locations (1)

IVI Sevilla; 🇪🇸 Sevilla, Spain