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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05079685
Other study ID # FIS-HyF
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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