SterilityNCT01406964
Chlamidia Antibodies Test for Tubal Factor Screening
A study testing CAT test and Histerosalpingography in people with Sterility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sterility
- What is being tested?
- CAT test and Histerosalpingography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age < 38 years
- FSH < 12.
- Treatment intrauterine insemination
Who cannot join
- Insulin dependent diabetes
- Thyroid disease
- Severe male factor
- Policystic ovarian syndrome
- Previous abdominal or uterine surgery
- Prevous abdominal or genital infections
Show all 9Show fewer
- Uterine myomas
- Hidrosalpinx
- Uterine congenital abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sterility
- Being tested
- CAT test, Histerosalpingography
- Keywords
- Chlamidia Antibody test, Hysterosalpyngography, Tubal disease
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAT testOther
A CAT test is performed in order to diagnose tubal factor causes
HisterosalpingographyOther
A Histerosalpingography is performed.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Arm A performs a CAT test to study tubal factor causes Receives: Other: CAT test |
| Arm B | Experimental | In Arm B a histerosalpingography is performed. Receives: Other: Histerosalpingography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SterilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01406964
- Sponsor's protocol ID
- VLC-JD-0904-025
- Status last verified
- Mar 2012
- First submitted
- 29 Jul 2011
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlamidia Antibodies Test for Tubal Factor Screening
- ClinicalTrials.gov ID
- NCT01406964
- Acronym / sponsor ID
- VLC-JD-0904-025
- Conditions
- Sterility
- Keywords
- Chlamidia Antibody test, Hysterosalpyngography, Tubal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Other: CAT testArm A performs a CAT test to study tubal factor causes |
| Arm B | Experimental | Other: HisterosalpingographyIn Arm B a histerosalpingography is performed. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age < 38 years
- FSH < 12.
- Treatment intrauterine insemination
Key exclusion criteria (9 listed)
- Insulin dependent diabetes
- Thyroid disease
- Severe male factor
- Policystic ovarian syndrome
- Previous abdominal or uterine surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAT testA CAT test is performed in order to diagnose tubal factor causes | Other | Arm A |
| HisterosalpingographyA Histerosalpingography is performed. | Other | Arm B |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAT test and Histerosalpingography in people with Sterility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy outcome using the two different treatments. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2012.