Ultrasound Study Through Uterine Texturization to Predict Pregnancy After Blastocyst Transfer in Patients Undergoing Hormone Replacement Therapy (HRT) Cycles With Donor Oocytes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- IVI Sevilla
- Locations
- 1
- Primary Endpoint
- Chemical pregnancy rate
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
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
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Chemical pregnancy rate
Time Frame: Around 14 days after embryo transfer
Positive result in beta HCG test indicating pregnancy
Clinical miscarriage rate
Time Frame: Up to 20 weeks after embryo transfer
Interruption of pregnancy after confirming clinical pregnancy using ultrasound scanning
beta HCG level
Time Frame: Around 14 days after embryo transfer
Level of beta HCG in the test performed to detect pregnancy
Clinical pregnancy rate
Time Frame: Around 5-6 weeks after embryo transfer
Detection of gestational sac through ultrasound scanning indicating clinical pregnancy
Biochemical miscarriage rate
Time Frame: Up to one month after embryo transfer
Interruption of pregnancy after a positive result in the beta HCG test