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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
It is a study in which tubal patency is studied through the technique of visualization of the tubes. The patients in the study will be only women.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Angela Morales Bueno | Hospital Universitario Virgen Macarena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen macarena | Seville | 41009 | Spain |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Compare the time it takes to see the effect of the study drug compared to HSG. |
| Up to 48 weeks. |