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

Infertility Clinical Trial

— TEXTUGEST  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03507322
• Other study ID #: 1605-SEV-034-IR
• Status: Withdrawn
• Start date: November 7, 2017
• Est. completion date: September 10, 2018

Study information

• Verified date: September 2018
• Source: IVI Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 10, 2018
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Ultrasound texturization
Along several visits to the clinic, the patients will be subjected to 2D/3D ultrasound scanning.

Locations

Country	Name	City	State
Spain	IVI Sevilla	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
IVI Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

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