Non Specific Chronic EndometritisendoMBNCT04103242
Abundance of Lactobacillus in Endometrium Affected by Chronic Endometritis
An observational study of Non Specific Chronic Endometritis and Infertility, Female, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Infertile women undergoing hysteroscopy for diagnostic or therapeutic indication are asked to donate a sample of endometrium. Endometrial samples of study participants are examined for signs of chronic endometritis by immunohistochemical analysis. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Non Specific Chronic Endometritis, Infertility, Female
- What is being tested?
- 16s rRNA gene sequencing
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Jan 2018to 28 Feb 2021
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Patients presenting at the Clinic for Reproductive Medicine of the University Hospital Basel because of infertility with an indication for HSC represent the project population.
Who may be able to join
- Infertile (≥ 12 months of unprotected regular intercourse) premenopausal women or women with ≥ 2 consecutive miscarriages undergoing hysteroscopy. - Infertile women undergoing office hysteroscopy for other reasons, such as suspected intrauterine adhesions after curettage, irregular endometrium, uterine polyps, repeated implantation failure in assisted reproduction, etc.
- Signed informed consent
- BMI ≥ 18 kg/m2 and ≤ 40 kg/m2
- Age: ≥ 18 years and ≤ 45 years
- follicle stimulating hormone (FSH) ≤ 20 (day 2-5 and estradiol ≤ 300 pmol/l)
Who cannot join
- Treatment with antibiotics in the past 3 months
- Treatment with immune-suppressing or immune-modulating drugs in the past 3 months
- Treatment with estrogens, progestins, contraceptives and/or antiestrogenic drugs in the cycle during which hysteroscopy is performed
- Current infection of the cervix with Chlamydia trachomatis and/or gonorrhea
- Pelvic surgery in the past 3 months
- Suspicion of malignancy
Show all 12Show fewer
- Pregnancy
- Breast feeding
- Perimenopause (irregular menses and FSH ≥ 20 U/l on day 3-5 of the cycle)
- Outdated endometrial sample from the luteal phase (this criterion will be evaluated during visit 4 post surgery)
- Elevated progesterone concentration ≥ 20 nmol/l measured in the blood sample taken at the time of HSC.
- Insufficient amount of tissue for immunohistochemical analysis and/or microbial 16s rRNA gene sequencing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Difference in Relative Abundance of Lactobacillus in Endometrium With and Without Histologically Proven Chronic Endometritis
Infertile women undergoing hysteroscopy for diagnostic or therapeutic indication are asked to donate a sample of endometrium.
Endometrial samples of study participants are examined for signs of chronic endometritis by immunohistochemical analysis.
High-throughput sequencing of the microbial 16s ribosomal ribonucleic acid (rRNA) subunit is performed to identify and quantify the microbes present in the sample.
Obstetric and reproductive outcome is recorded 12 months after hysteroscopy (telephone interview).
- Being tested
- 16s rRNA gene sequencing
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16s rRNA gene sequencingOther
High-throughput sequencing of the microbial 16s rRNA subunit to define the abundance of microbial phyla and genera
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of Lactobacillus
Quantity of Lactobacillus determined by 16S ribosomal RNA gene sequencing
Measured: 1 year
alpha diversity of microbes
Quantification of microbes and their diversity within the individual endometrium sample
Measured: 1 year
Shannon index (Beta diversity)
Comparison of microbial diversity among the subjects
Measured: 1 Year
Secondary outcomes (2)
Pregnancy Rate
Number of pregnancies within 12 months after hysteroscopy
Measured: 2 years
Live Birth Rate
Number of pregnancies within 12 months after hysteroscopy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start2 Jan 2018
- Primary completion12 Feb 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Specific Chronic EndometritisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca Moffat, MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103242
- Sponsor's protocol ID
- 2017-01064 endoMB
- Other IDs
- 2017
- Acronym
- endoMB
- Status last verified
- Dec 2024
- First submitted
- 31 Oct 2018
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Difference in Relative Abundance of Lactobacillus in Endometrium With and Without Histologically Proven Chronic Endometritis
- ClinicalTrials.gov ID
- NCT04103242
- Acronym / sponsor ID
- endoMB / 2017-01064 endoMB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 12 Feb 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 25 Sep 2019 (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.
Infertile women undergoing hysteroscopy for diagnostic or therapeutic indication are asked to donate a sample of endometrium.
Endometrial samples of study participants are examined for signs of chronic endometritis by immunohistochemical analysis.
High-throughput sequencing of the microbial 16s ribosomal ribonucleic acid (rRNA) subunit is performed to identify and quantify the microbes present in the sample.
Obstetric and reproductive outcome is recorded 12 months after hysteroscopy (telephone interview).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients presenting at the Clinic for Reproductive Medicine of the University Hospital Basel because of infertility with an indication for HSC represent the project population.
Key inclusion criteria (5 listed)
- Infertile (≥ 12 months of unprotected regular intercourse) premenopausal women or women with ≥ 2 consecutive miscarriages undergoing hysteroscopy. - Infertile women undergoing office hysteroscopy for other reasons, such as suspected intrauterine adhesions after curettage, irregular endometrium, uterine polyps, repeated implantation failure in assisted reproduction, etc.
- Signed informed consent
- BMI ≥ 18 kg/m2 and ≤ 40 kg/m2
- Age: ≥ 18 years and ≤ 45 years
- follicle stimulating hormone (FSH) ≤ 20 (day 2-5 and estradiol ≤ 300 pmol/l)
Key exclusion criteria (12 listed)
- Treatment with antibiotics in the past 3 months
- Treatment with immune-suppressing or immune-modulating drugs in the past 3 months
- Treatment with estrogens, progestins, contraceptives and/or antiestrogenic drugs in the cycle during which hysteroscopy is performed
- Current infection of the cervix with Chlamydia trachomatis and/or gonorrhea
- Pelvic surgery in the past 3 months
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 |
|---|---|---|
| 16s rRNA gene sequencingHigh-throughput sequencing of the microbial 16s rRNA subunit to define the abundance of microbial phyla and genera | Other | – |
Primary outcome
Quantity of Lactobacillus
Time frame: 1 year
Quantity of Lactobacillus determined by 16S ribosomal RNA gene sequencing
alpha diversity of microbes
Time frame: 1 year
Quantification of microbes and their diversity within the individual endometrium sample
Shannon index (Beta diversity)
Time frame: 1 Year
Comparison of microbial diversity among the subjects
2 secondary outcomes
Pregnancy Rate
Time frame: 2 years
Live Birth Rate
Time frame: 3 years
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 4 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Rebecca Moffat, MD principal investigator
University Hospital, Basel, Switzerland
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 Non Specific Chronic Endometritis and Infertility, Female, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 5 inclusion and 12 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 4 Dec 2024. 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 Switzerland. 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?
Quantity of Lactobacillus (time frame: 1 year). The study lists 3 primary outcomes in all. 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 4 Dec 2024.