Tubal PatencyNCT05079685
HyFoSy Versus HSG as a Diagnostic Technique for Tubal Patency.
An observational study of Tubal Patency and Sterility, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Tubal Patency, Sterility
- How many people
- 112 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2021to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Tubal Patency, Sterility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 48 weeks.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Oct 2021
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tubal PatencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angela Morales Bueno, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079685
- Sponsor's protocol ID
- FIS-HyF
- Status last verified
- Oct 2021
- First submitted
- 4 Oct 2021
- Last updated
- 17 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HyFoSy Versus HSG as a Diagnostic Technique for Tubal Patency: a Prospective Case-control Study.
- ClinicalTrials.gov ID
- NCT05079685
- Acronym / sponsor ID
- FIS-HyF
- Conditions
- Tubal Patency, Sterility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza para la gestión de la Investigación en SevillaUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study of tubal patency and establish the concordance of results between HyFoSy and HSG.
Time frame: Up to 48 weeks.
Concordance study between HyFoSy and HSG. It is a qualitative study (yes / no).
2 secondary outcomes
Rate of occurrence of complications in the patients included in the study.
Time frame: Up to 48 weeks.
Time costs of performing HyFoSy versus HSG.
Time frame: Up to 48 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2021.
Related trials for Tubal Patency
Recruiting
Assessment of Tubal Occlusion During Minimally Invasive Myomectomy
Fallopian Tube Patency Tests, Fibroid/Myoma (Uterus/Cervix)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Morales Bueno principal investigator
Hospital Universitario Virgen Macarena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tubal Patency and Sterility, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of tubal patency and establish the concordance of results between HyFoSy and HSG. (time frame: Up to 48 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.