HyFoSy Versus HSG as a Diagnostic Technique for Tubal Patency.

• Conditions: Tubal Patency; Sterility

• Registration Number: NCT05079685
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Brief 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).

Study Timeline

• Status Verified: 2021-10
• Study Start: 2021-10-01
• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-04
• Study First Posted: 2021-10-15
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-17
• Primary Completion: 2022-09-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 112

Inclusion Criteria

• Women between 18-39 years, under study for primary sterility, with BMI <30, AMH> 0.6 (good ovarian reserve), subsidiaries of Conjugal or Donor IA, according to the 2019 SAS Reproduction Guide.

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Exclusion Criteria

• Women <19 or> 39 years old, BMI> 30, secondary sterility, previous tubal sterilization, that is, the ART exclusion criteria according to the 2019 SAS Reproduction Guide.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Study of tubal patency and establish the concordance of results between HyFoSy and HSG.	Up to 48 weeks.	Concordance study between HyFoSy and HSG. It is a qualitative study (yes / no).

Secondary Outcome Measures

Name	Time	Method
Rate of occurrence of complications in the patients included in the study.	Up to 48 weeks.	Expand the knowledge of the complications in the clinical practice of HyFoSy, confirming the lower perception of pain and the therapeutic effect of HyFoSy.
Time costs of performing HyFoSy versus HSG.	Up to 48 weeks.	Compare the time it takes to see the effect of the study drug compared to HSG.

Trial Locations

Locations (1)

Hospital Universitario Virgen macarena; 🇪🇸 Sevilla, Spain