PeriodontitisNCT01140945
Association Study Between Periodontal Disease and Male Infertility
An observational study of Periodontitis and Sub-fertility, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The aim of the present study is to examine the association between fertility parameters and the periodontal status of men attending fertility and in vitro fertilization clinic. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men only
- Conditions the study is for
- Periodontitis, Sub-fertility
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Observational
- 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 20 to 50 years
- Men only
- Adult
Study population: Males attending in vitro fertiliztion clinic
Who may be able to join
- Consent to participate in study
Who cannot join
- Systemic uncontrolled disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Periodontal Status of Males Attending in Vitro Fertilization Clinic
The aim of the present study is to examine the association between fertility parameters and the periodontal status of men attending fertility and in vitro fertilization clinic.
Read the detailed description
An association has been found between periodontal diseases and preterm low birth weight, coronary heart disease, and cerebral infarction. Anaerobic gram negative bacterial plaque that forms subgingivally is the direct causative factor for the development of Gingivitis and Periodontitis.
However, its possible association with male infertility have not yet been investigated.
- Conditions
- Periodontitis, Sub-fertility
- Medical subject headings
- Periodontitis, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Males attending in vitro fertilization clinic | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive association between periodontitis and infertility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140945
- Sponsor's protocol ID
- Klinger-HMO-CTIL
- Status last verified
- Jan 2010
- First submitted
- 9 Jun 2010
- Last updated
- 10 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Klinger A, Hain B, Yaffe H, Schonberger O. Periodontal status of males attending an in vitro fertilization clinic. J Clin Periodontol. 2011 Jun;38(6):542-6. doi: 10.1111/j.1600-051X.2011.01720.x. Epub 2011 Mar 28.
PubMed 21443558
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Status of Males Attending in Vitro Fertilization Clinic
- ClinicalTrials.gov ID
- NCT01140945
- Acronym / sponsor ID
- Klinger-HMO-CTIL
- Conditions
- Periodontitis, Sub-fertility
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 10 Jun 2010 (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 the present study is to examine the association between fertility parameters and the periodontal status of men attending fertility and in vitro fertilization clinic.
Detailed description
An association has been found between periodontal diseases and preterm low birth weight, coronary heart disease, and cerebral infarction. Anaerobic gram negative bacterial plaque that forms subgingivally is the direct causative factor for the development of Gingivitis and Periodontitis.
However, its possible association with male infertility have not yet been investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Males attending in vitro fertilization clinic | – | – |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- Males attending in vitro fertiliztion clinic
Key inclusion criteria (1 listed)
- Consent to participate in study
Key exclusion criteria (1 listed)
- Systemic uncontrolled disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive association between periodontitis and infertility
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 10 Jun 2010.
- Derived from this study: PubMed 21443558Klinger A, Hain B, Yaffe H, Schonberger O. Periodontal status of males attending an in vitro fertilization clinic. J Clin Periodontol. 2011 Jun;38(6):542-6. doi: 10.1111/j.1600-051X.2011.01720.x. Epub 2011 Mar 28.
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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?
An observational study of Periodontitis and Sub-fertility, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 1 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 10 Jun 2010. 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 Israel. 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?
Positive association between periodontitis and infertility. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01140945, which also lists 1 linked publication.
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 10 Jun 2010.