HyFoSy Versus HSG as a Diagnostic Technique for Tubal Patency.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2022-11-01

Brief Summary

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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

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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).

Conditions

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Tubal Patency Sterility

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela Morales Bueno

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen Macarena

Locations

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Hospital Universitario Virgen macarena

Seville, , Spain

Site Status

Countries

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Spain

Other Identifiers

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FIS-HyF

Identifier Type: -

Identifier Source: org_study_id