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

Study Overview
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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

Official Title
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Ultrasound Study Through Uterine Texturization to Predict Pregnancy After Blastocyst Transfer in Patients Undergoing Hormone Replacement Therapy (HRT) Cycles With Donor Oocytes

Conditions
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Infertility

Intervention / Treatment
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* Other: Ultrasound texturization


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ultrasound texturization<br>Application of ultrasound texturization (2D/3D ultrasound scanning) | Other: Ultrasound texturization<br>* Along several visits to the clinic, the patients will be subjected to 2D/3D ultrasound scanning.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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texturization, pregnancy rate, oocyte donation, 2D ultrasound, 3D ultrasound, assisted reproductive technology (ART)