Chlamidia Antibodies Test for Tubal Factor Screening

This study has been completed.
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01406964
First received: July 29, 2011
Last updated: March 30, 2012
Last verified: March 2012
  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: Open Label
Primary Purpose: Diagnostic
Official Title: Chlamidia Antibodies Test for Tubal Factor Screening

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

Primary Outcome Measures:
  • Pregnancy outcome using the two different treatments. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 38 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406964

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

No publications provided

Responsible Party: Dr. Juan Giles, IVI Valencia
ClinicalTrials.gov Identifier: NCT01406964     History of Changes
Other Study ID Numbers: VLC-JD-0904-025
Study First Received: July 29, 2011
Last Updated: March 30, 2012
Health Authority: Spain: Ministry of Health

Keywords provided by Instituto Valenciano de Infertilidad, Spain:
Chlamidia Antibody test, Hysterosalpyngography, Tubal disease

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014