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

NCT03507322 | Withdrawn

• 1 other identifier: 1605-SEV-034-IR
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility

Keywords

texturization; pregnancy rate; oocyte donation; 2D ultrasound; 3D ultrasound; assisted reproductive technology (ART)

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

Ultrasound texturization

Application of ultrasound texturization (2D/3D ultrasound scanning)

Other: Ultrasound texturization

Interventions

Ultrasound texturization OTHER

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

Ultrasound texturization

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Infertile women undergoing IVF/ICSI treatment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vida Recoletas Sevilla: lead

Study Sites (1)

IVI Sevilla

Seville, 41011, Spain

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: April 25, 2018
• Study Start: November 7, 2017
• Primary Completion: September 10, 2018
• Study Completion: September 10, 2018
• Last Updated: September 12, 2018

Record last verified: 2018-09

Locations

ES (1)