Mycoplasma Genitalium InfectionMYCOCLEARNCT04841408
Prospective, Monocentric, Interventional Study on Spontaneous Vaginal Clearance of Mycoplasma Genitalium
A study testing Vaginal self-sampling in people with Mycoplasma Genitalium Infection, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
It is a prospective, monocentric, interventional study on spontaneous vaginal clearance of Mycoplasma genitalium. The main objective is to evaluate the spontaneous vaginal clearance of M. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mycoplasma Genitalium Infection
- What is being tested?
- Vaginal self-sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteFrance
- Study dates
- 5 Apr 2021to 21 Feb 2023
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient selected during the first consultation, pre-abortion, and having a vaginal swab positive to M. genitalium.
- Patient hospitalized for an abortion at the University Hospital of Bordeaux.
- An affiliated patient or beneficiary of a social security system.
- Signing free and informed consent.
Who cannot join
- Patient with vaginal co-infection with C. trachomatis.
- Patient with symptoms of high genital infection.
- Taking fluoroquinolones, macrolides or tetracyclines within 21 days of inclusion.
- Patient under legal protection.
Trial locations and contacts
1 site in 1 country.
About this study
It is a prospective, monocentric, interventional study on spontaneous vaginal clearance of Mycoplasma genitalium.
The main objective is to evaluate the spontaneous vaginal clearance of M. genitalium in patients coming to perform a voluntary termination of pregnancy at the University Hospital of Bordeaux at 9 weeks after a vaginal sample positive for M. genitalium
Read the detailed description
Mycoplasma genitalium is a bacterium that colonizes female genital tract and can be responsible for sexually transmitted infection . M. genitalium can cause cervicitis and more rarely high genital infections.
In the vast majority of cases, presence of M. genitalium is not accompanied by any symptoms and women do not develop disease. Natural history of M. genitalium infection is not well documented. Some studies have shown a natural clearance of infection in women. The published work mainly concerns patients at very high risk of sexually transmitted disease, but we do not have French data.
We propose to study the natural clearance of M. genitalium infection in patients consulting at the Orthogeny Centre of the University Hospital of Bordeaux. Results of this work will allow us to have a better knowledge of the natural history of M. genitalium infection.
- Conditions
- Mycoplasma Genitalium Infection
- Being tested
- Vaginal self-sampling
- Keywords
- Mycoplasma genitalium, abortion, clearance, IST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal self-samplingOther
Vaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Vaginal self-sampling | Experimental | Vaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks. Receives: Other: Vaginal self-sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
clearance at week 3
The clearance will be defined by a negative PCR test for M. genitalium in the vaginal sample taken at week 3.
Measured: Week 3
Secondary outcomes (5)
clearance at week 9
The clearance defined by a negative PCR test for M. genitalium in the vaginal sample taken at week 9.
Measured: Week 9
Prevalence of N. gonorrhoeae infections
Prevalence of infections with N. gonorrhoeae calculated by making the ratio between the number of patients with a positive vaginal swab for N. gonorrhoeae compared to the total number of patients tested.
Measured: Week 3, Week 9
Prevalence of C. trachomatis infections
Prevalence of infections with C. trachomatis calculated by making the ratio between the number of patients with a positive vaginal swab for C. trachomatis compared to the total number of patients tested.
Measured: Week 3, Week 9
Prevalence of M. genitalium infections
Prevalence of infections with M. genitalium, calculated by making the ratio between the number of patients with a positive vaginal swab for M. genitalium compared to the total number of patients tested.
Measured: Week 3, Week 9
patient's sex life
patient's sex life, assessed by a self-questionnaire
Measured: Week 3, Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start5 Apr 2021
- Primary completion31 Jan 2023
- Study completion21 Feb 2023
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 Mycoplasma Genitalium InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Vaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841408
- Sponsor's protocol ID
- CHUBX 2021/06
- Acronym
- MYCOCLEAR
- Status last verified
- Apr 2023
- First submitted
- 7 Apr 2021
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Berdoyes M, Bebear C, Roy CL, Balcon C, Hocke C, Baita D, Peuchant O. Spontaneous Clearance of Vaginal Mycoplasma genitalium in Women Undergoing Pregnancy Termination: A Prospective Cohort Study. BJOG. 2026 Apr;133(5):1074-1082. doi: 10.1111/1471-0528.70151. Epub 2026 Jan 7.
PubMed 41502158
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Monocentric, Interventional Study on Spontaneous Vaginal Clearance of Mycoplasma Genitalium
- ClinicalTrials.gov ID
- NCT04841408
- Acronym / sponsor ID
- MYCOCLEAR / CHUBX 2021/06
- Conditions
- Mycoplasma Genitalium Infection
- Keywords
- Mycoplasma genitalium, abortion, clearance, IST
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 21 Feb 2023 (actual)
- First posted
- 12 Apr 2021 (actual)
- 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.
It is a prospective, monocentric, interventional study on spontaneous vaginal clearance of Mycoplasma genitalium.
The main objective is to evaluate the spontaneous vaginal clearance of M. genitalium in patients coming to perform a voluntary termination of pregnancy at the University Hospital of Bordeaux at 9 weeks after a vaginal sample positive for M. genitalium
Detailed description
Mycoplasma genitalium is a bacterium that colonizes female genital tract and can be responsible for sexually transmitted infection . M. genitalium can cause cervicitis and more rarely high genital infections.
In the vast majority of cases, presence of M. genitalium is not accompanied by any symptoms and women do not develop disease. Natural history of M. genitalium infection is not well documented. Some studies have shown a natural clearance of infection in women. The published work mainly concerns patients at very high risk of sexually transmitted disease, but we do not have French data.
We propose to study the natural clearance of M. genitalium infection in patients consulting at the Orthogeny Centre of the University Hospital of Bordeaux. Results of this work will allow us to have a better knowledge of the natural history of M. genitalium infection.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Vaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks
| Arm | Type | Receives |
|---|---|---|
| Vaginal self-sampling | Experimental | Other: Vaginal self-samplingVaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient selected during the first consultation, pre-abortion, and having a vaginal swab positive to M. genitalium.
- Patient hospitalized for an abortion at the University Hospital of Bordeaux.
- An affiliated patient or beneficiary of a social security system.
- Signing free and informed consent.
Key exclusion criteria (4 listed)
- Patient with vaginal co-infection with C. trachomatis.
- Patient with symptoms of high genital infection.
- Taking fluoroquinolones, macrolides or tetracyclines within 21 days of inclusion.
- Patient under legal protection.
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 |
|---|---|---|
| Vaginal self-samplingVaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks. | Other | Vaginal self-sampling |
Primary outcome
clearance at week 3
Time frame: Week 3
The clearance will be defined by a negative PCR test for M. genitalium in the vaginal sample taken at week 3.
5 secondary outcomes
clearance at week 9
Time frame: Week 9
Prevalence of N. gonorrhoeae infections
Time frame: Week 3, Week 9
Prevalence of C. trachomatis infections
Time frame: Week 3, Week 9
Prevalence of M. genitalium infections
Time frame: Week 3, Week 9
patient's sex life
Time frame: Week 3, Week 9
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 28 Apr 2023.
- Derived from this study: PubMed 41502158Berdoyes M, Bebear C, Roy CL, Balcon C, Hocke C, Baita D, Peuchant O. Spontaneous Clearance of Vaginal Mycoplasma genitalium in Women Undergoing Pregnancy Termination: A Prospective Cohort Study. BJOG. 2026 Apr;133(5):1074-1082. doi: 10.1111/1471-0528.70151. Epub 2026 Jan 7.
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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 Vaginal self-sampling in people with Mycoplasma Genitalium Infection, run by University Hospital, Bordeaux at 1 site in France.
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 4 inclusion and 4 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 28 Apr 2023. 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 France. 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?
clearance at week 3 (time frame: Week 3). 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 NCT04841408, 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 28 Apr 2023.