NCT05079685

HyFoSy Versus HSG as a Diagnostic Technique for Tubal Patency.

HyFoSy Versus HSG as a Diagnostic Technique for Tubal Patency: a Prospective Case-control Study.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 112 (estimated)
• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Academic / Other
• Sex: Female
• Age: 18 Years – 39 Years
• Healthy volunteers: Not accepted

Summary

Observational, single-center, prospective case-control study, in which each patient is his own control. It focuses on the study of tubal patency and establishing the agreement of results between HyFoSy and HSG.

Detailed description

Observational, single-center, case-control study in which tubal pathology is studied in the context of a Basic Sterility Study. The main objective of this study is to demonstrate the concordance of this new diagnostic test (HyFoSy) with HSG, which is the common technique to visualize tubal patency. Once demonstrated concordance, we also want to carry out a cost-effectiveness study and demonstrate through different scales the greater ease of the test, less time to perform and less pain for the patient. It is a study in which the patients are women between 18-39 years old, undergoing study for primary sterility, with a BMI \<30, AMH\> 0.6 (good ovarian reserve).

Conditions

• Tubal Patency
• Sterility

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-09-01
• Completion: 2022-11-01
• First posted: 2021-10-15
• Last updated: 2021-11-17

Locations

1 site across 1 country: Spain