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Chlamidia Antibodies Test for Tubal Factor Screening

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01406964
First Posted: August 1, 2011
Last Update Posted: April 2, 2012
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.
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA
  Purpose
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 Intervention
Sterility Other: CAT test Other: Histerosalpingography

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Chlamidia Antibodies Test for Tubal Factor Screening

Further study details as provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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.


Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01406964


Locations
Spain
IVI Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
  More Information

Responsible Party: Dr. Juan Giles, IVI Valencia
ClinicalTrials.gov Identifier: NCT01406964     History of Changes
Other Study ID Numbers: VLC-JD-0904-025
First Submitted: July 29, 2011
First Posted: August 1, 2011
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:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Antibodies
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs