NCT01406964

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

April 2, 2012

Status Verified

March 1, 2012

Enrollment Period

5 months

First QC Date

July 29, 2011

Last Update Submit

March 30, 2012

Conditions

Sterility

Keywords

Chlamidia Antibody test, Hysterosalpyngography, Tubal disease

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Study Arms (2)

Arm A

EXPERIMENTAL

Arm A performs a CAT test to study tubal factor causes

Other: CAT test

Arm B

EXPERIMENTAL

In Arm B a histerosalpingography is performed.

Other: Histerosalpingography

Interventions

CAT testOTHER

A CAT test is performed in order to diagnose tubal factor causes

Arm A
HisterosalpingographyOTHER

A Histerosalpingography is performed.

Arm B

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age \< 38 years
  • FSH \< 12.
  • Treatment intrauterine insemination

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Valencia

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2011

First Posted

August 1, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

April 2, 2012

Record last verified: 2012-03

Locations

ES(1)