Chlamidia Antibodies Test for Tubal Factor Screening

This study has been completed.
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, IVI VALENCIA
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, IVI VALENCIA:

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
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, see Learn About Clinical Studies.

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, IVI VALENCIA
  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, IVI VALENCIA:
Chlamidia Antibody test, Hysterosalpyngography, Tubal disease

Additional relevant MeSH terms:
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 02, 2014