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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Sterility; Tubal Patency

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 Type: Observational
• Enrollment (Anticipated): 112

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cases-Control; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Investigators: Principal Investigator: Angela Morales Bueno, Hospital Universitario Virgen Macarena

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): November 1, 2022

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (ACTUAL): October 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2021
• Last Update Submitted That Met QC Criteria: November 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: FIS-HyF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No