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Chlamidia Antibodies Test for Tubal Factor Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01406964
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : April 2, 2012
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Condition or disease Intervention/treatment Phase
Sterility Other: CAT test Other: Histerosalpingography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Chlamidia Antibodies Test for Tubal Factor Screening
Study Start Date : July 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: Arm A
Arm A performs a CAT test to study tubal factor causes
Other: CAT test
A CAT test is performed in order to diagnose tubal factor causes

Experimental: Arm B
In Arm B a histerosalpingography is performed.
Other: Histerosalpingography
A Histerosalpingography is performed.

Primary Outcome Measures :
  1. Pregnancy outcome using the two different treatments. [ Time Frame: 6 months ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01406964

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IVI Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
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Responsible Party: Dr. Juan Giles, IVI Valencia Identifier: NCT01406964    
Other Study ID Numbers: VLC-JD-0904-025
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: April 2, 2012
Last Verified: March 2012
Keywords provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:
Chlamidia Antibody test, Hysterosalpyngography, Tubal disease
Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female