Status:
COMPLETED
Abundance of Lactobacillus in Endometrium Affected by Chronic Endometritis
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Non Specific Chronic Endometritis
Infertility, Female
Eligibility:
FEMALE
18-45 years
Brief 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 chron...
Eligibility Criteria
Inclusion
- 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
- 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- Outdated endometrial sample from the luteal phase (this criterion will be evaluated during visit 4 post surgery)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
Key Trial Info
Start Date :
January 2 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04103242
Start Date
January 2 2018
End Date
February 28 2021
Last Update
December 4 2024
Active Locations (1)
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1
University Hospital Basel
Basel, Switzerland, 4031