Back to resultsChlamidia Antibodies Test for Tubal Factor Screening
Primary Purpose
Sterility
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
CAT test
Histerosalpingography
Sponsored by
About this trial
This is an interventional diagnostic trial for Sterility focused on measuring Chlamidia Antibody test, Hysterosalpyngography, Tubal disease
Eligibility Criteria
Inclusion Criteria:
- Age < 38 years
- FSH < 12.
- Treatment intrauterine insemination
Exclusion Criteria:
- Insulin dependent diabetes
- Thyroid disease
- Severe male factor
- Policystic ovarian syndrome
- Previous abdominal or uterine surgery
- Prevous abdominal or genital infections
- Uterine myomas
- Hidrosalpinx
- Uterine congenital abnormalities
Sites / Locations
- IVI Valencia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm A
Arm B
Arm Description
Arm A performs a CAT test to study tubal factor causes
In Arm B a histerosalpingography is performed.
Outcomes
Primary Outcome Measures
Pregnancy outcome using the two different treatments.
Pregnancy rate, cumulative pregnancy rate and ectopic pregnancy rate in order to evaluate de usefulness of the CAT test as a predictor of tubal pathology.
Secondary Outcome Measures
Full Information
NCT ID
NCT01406964
First Posted
July 29, 2011
Last Updated
March 30, 2012
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
1. Study Identification
Unique Protocol Identification Number
NCT01406964
Brief Title
Chlamidia Antibodies Test for Tubal Factor Screening
Official Title
Chlamidia Antibodies Test for Tubal Factor Screening
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the usefulness of a Chlamydia Antibody Test for screening of tubal factor in patients who undergo artificial insemination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sterility
Keywords
Chlamidia Antibody test, Hysterosalpyngography, Tubal disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
Arm A performs a CAT test to study tubal factor causes
Arm Title
Arm B
Arm Type
Experimental
Arm Description
In Arm B a histerosalpingography is performed.
Intervention Type
Other
Intervention Name(s)
CAT test
Intervention Description
A CAT test is performed in order to diagnose tubal factor causes
Intervention Type
Other
Intervention Name(s)
Histerosalpingography
Intervention Description
A Histerosalpingography is performed.
Primary Outcome Measure Information:
Title
Pregnancy outcome using the two different treatments.
Description
Pregnancy rate, cumulative pregnancy rate and ectopic pregnancy rate in order to evaluate de usefulness of the CAT test as a predictor of tubal pathology.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age < 38 years
FSH < 12.
Treatment intrauterine insemination
Exclusion Criteria:
Insulin dependent diabetes
Thyroid disease
Severe male factor
Policystic ovarian syndrome
Previous abdominal or uterine surgery
Prevous abdominal or genital infections
Uterine myomas
Hidrosalpinx
Uterine congenital abnormalities
Facility Information:
Facility Name
IVI Valencia
City
Valencia
ZIP/Postal Code
46015
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Chlamidia Antibodies Test for Tubal Factor Screening
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