Bacterial VaginosesNCT04393857
The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in Oocyte Donors
An observational study of Bacterial Vaginoses, run by Peter Humaidan at 1 site in Spain.
Trial summary
The investigators aim to examine the endometrium with state of the art sequencing techniques to investigate the endometrial microbiota. The endometrial microbiota has been perceived to be sterile, however, this seems incorrect from recent studies. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Bacterial Vaginoses
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 15 May 2020to 1 Jul 2020
- 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 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Study population: Healthy oocyte donors
Who may be able to join
- Oocyte donors meeting local criteria for donation. Written informed consent. Regular cycle
Who cannot join
- Antibiotics within 1 month Vaginal products other than for menstrual hygiene within 1 month Uterine malformations(Septum, polyps, adenomyosis, fibroids) HIV, Hepatitis B or C positivity. HPV CIN 2 or higher. Chlamydia trachomatis positivity.
- Any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aim to examine the endometrium with state of the art sequencing techniques to investigate the endometrial microbiota. The endometrial microbiota has been perceived to be sterile, however, this seems incorrect from recent studies. Thus, the primary outcome is to compare the rate of ascending infection from the vagina to the endometrium and to investigate which bacteria are capable of inhabiting these environments in healthy oocyte donors. These results will be compared to equivalent samples of IVF patients.
- Conditions
- Bacterial Vaginoses
- Medical subject headings
- Vaginosis, Bacterial
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 |
|---|---|---|
| Oocyte donors | Healthy Oocyte donors fulfilling the criteria for oocyte donation are eligible. Patients may not have received any antibiotics or vaginal products (other than for menstrual hygiene - such as tampons) for the last 1 month. Informed consent is mandatory. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ascending infection/sharing of bacteria in the genital tract
vaginal, cervical and endometrial samples will be compared at the time of oocyte retrieval.
Measured: This outcome data is measured at the 1 day of oocyte retrieval.
Secondary outcomes (1)
Next generation sequencing techniques and qPCR will be used to assess the microbiota.I.e. measure of relative abundances and absolute abundances
qPCR to assess the microbiota. I.e. a quantitative measure Copies/mL. 16S V4 to investigate relative abundances
Measured: This outcome data is measured at the 1 day of oocyte retrieval.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start15 May 2020
- Primary completion1 Jul 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial VaginosesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter Humaidan
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Bernabeu
- Responsible party
- Sponsor-investigator, Peter Humaidan, Regionshospitalet Viborg, Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393857
- Sponsor's protocol ID
- Microbiome_endometrial_spain
- Status last verified
- Feb 2021
- First submitted
- 14 May 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: WE plan to share all information allowed as per national law.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Temporo-spatial Dynamics of Genital Tract Microbiota - an Observational Study in Oocyte Donors
- ClinicalTrials.gov ID
- NCT04393857
- Acronym / sponsor ID
- Microbiome_endometrial_spain
- Conditions
- Bacterial Vaginoses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Peter HumaidanUniversity, hospital or other
- Collaborators
- Instituto Bernabeu
- Study start
- 15 May 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 19 May 2020 (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.
The investigators aim to examine the endometrium with state of the art sequencing techniques to investigate the endometrial microbiota. The endometrial microbiota has been perceived to be sterile, however, this seems incorrect from recent studies. Thus, the primary outcome is to compare the rate of ascending infection from the vagina to the endometrium and to investigate which bacteria are capable of inhabiting these environments in healthy oocyte donors. These results will be compared to equivalent samples of IVF patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oocyte donors | – | –Healthy Oocyte donors fulfilling the criteria for oocyte donation are eligible. Patients may not have received any antibiotics or vaginal products (other than for menstrual hygiene - such as tampons) for the last 1 month. Informed consent is mandatory. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Healthy oocyte donors
Key inclusion criteria (1 listed)
- Oocyte donors meeting local criteria for donation. Written informed consent. Regular cycle
Key exclusion criteria (2 listed)
- Antibiotics within 1 month Vaginal products other than for menstrual hygiene within 1 month Uterine malformations(Septum, polyps, adenomyosis, fibroids) HIV, Hepatitis B or C positivity. HPV CIN 2 or higher. Chlamydia trachomatis positivity.
- Any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)
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
Rate of ascending infection/sharing of bacteria in the genital tract
Time frame: This outcome data is measured at the 1 day of oocyte retrieval.
vaginal, cervical and endometrial samples will be compared at the time of oocyte retrieval.
1 secondary outcome
Next generation sequencing techniques and qPCR will be used to assess the microbiota.I.e. measure of relative abundances and absolute abundances
Time frame: This outcome data is measured at the 1 day of oocyte retrieval.
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 9 Feb 2021.
- Individual participant dataSharing planned: Undecided. WE plan to share all information allowed as per national law.
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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 Bacterial Vaginoses, run by Peter Humaidan 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 1 inclusion and 2 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 9 Feb 2021. 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?
Rate of ascending infection/sharing of bacteria in the genital tract (time frame: This outcome data is measured at the 1 day of oocyte retrieval.). 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 9 Feb 2021.