HyFoSy Versus HSG as a Diagnostic Technique for Tubal Patency.

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Status: Unknown

Conditions: Tubal Patency; Sterility

Study type: Observational

Funder types: Other

Identifiers

NCT05079685

FIS-HyF

Details and patient eligibility

About

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.

Full 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).

Enrollment: 112 estimated patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

112 participants in 1 patient group

Cases-Control

Description:

Women aged 18-39 years, with BMI \<30 and good ovarian reserve, undergoing study for primary sterility, subsidiary of conducting tubal patency studies to rule out pathology of the same and thus be able to perform Spousal or Donor IA.