Infertility, Female, Non Specific Chronic Endometritis
Conditions
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 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).
Interventions
High-throughput sequencing of the microbial 16s rRNA subunit to define the abundance of microbial phyla and genera
Sponsors
University Hospital, Basel, Switzerland
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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malignancy * Pregnancy * Breast feeding * Perimenopause (irregular menses and FSH ≥ 20 U/l on day 3-5 of the cycle) * Outdated endometrial sample from the luteal phase (this criterion will be evaluated during visit 4 post surgery) * Elevated progesterone concentration ≥ 20 nmol/l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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantity of Lactobacillus | 1 year | Quantity of Lactobacillus determined by 16S ribosomal RNA gene sequencing |
| alpha diversity of microbes | 1 year | Quantification of microbes and their diversity within the individual endometrium sample |
| Shannon index (Beta diversity) | 1 Year | Comparison of microbial diversity among the subjects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Rate | 2 years | Number of pregnancies within 12 months after hysteroscopy |
| Live Birth Rate | 3 years | Number of pregnancies within 12 months after hysteroscopy |
Countries
Switzerland
Outcome results
None listed