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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05079685

Enrollment

112

Registered

2021-10-15

Start date

2021-10-01

Completion date

2022-11-01

Last updated

2021-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sterility, Tubal Patency

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).

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 39 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Spain

Outcome results