Abundance of Lactobacillus in Endometrium Affected by Chronic Endometritis (NCT04103242) | Clinical Trial Compass
CompletedNot Applicable
Abundance of Lactobacillus in Endometrium Affected by Chronic Endometritis
Switzerland23 participantsStarted 2018-01-02
Plain-language 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.
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).
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
* 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* Outdated endometrial sample from the luteal phase (this criterion will be evaluated during visit 4 post surgery)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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.