NCT05079685

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 15, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

November 17, 2021

Status Verified

October 1, 2021

Enrollment Period

11 months

First QC Date

October 4, 2021

Last Update Submit

November 15, 2021

Conditions

Tubal PatencySterility

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Rate of occurrence of complications in the patients included in the study.

    Up to 48 weeks.

  • Time costs of performing HyFoSy versus HSG.

    Up to 48 weeks.

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIt 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.
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Virgen macarena

Seville, 41009, Spain

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Angela Morales Bueno

    Hospital Universitario Virgen Macarena

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2021

First Posted

October 15, 2021

Study Start

October 1, 2021

Primary Completion

September 1, 2022

Study Completion

November 1, 2022

Last Updated

November 17, 2021

Record last verified: 2021-10

Locations

ES(1)