HyFoSy Versus HSG as a Diagnostic Technique for Tubal Patency.

Sterility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05079685
• Other study ID #: FIS-HyF
• Status: Active, not recruiting
• Start date: October 1, 2021
• Est. completion date: November 1, 2022

Study information

• Verified date: October 2021
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 112
• Est. completion date: November 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Sterility
• Tubal Patency

Locations

Country	Name	City	State
Spain	Hospital Universitario Virgen macarena	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study of tubal patency and establish the concordance of results between HyFoSy and HSG.	Concordance study between HyFoSy and HSG. It is a qualitative study (yes / no).	Up to 48 weeks.
Secondary	Rate of occurrence of complications in the patients included in the study.	Expand the knowledge of the complications in the clinical practice of HyFoSy, confirming the lower perception of pain and the therapeutic effect of HyFoSy.	Up to 48 weeks.
Secondary	Time costs of performing HyFoSy versus HSG.	Compare the time it takes to see the effect of the study drug compared to HSG.	Up to 48 weeks.