Abundance of Lactobacillus in Endometrium Affected by Chronic Endometritis

Study Overview
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Brief Summary
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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).

Official Title
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Difference in Relative Abundance of Lactobacillus in Endometrium With and Without Histologically Proven Chronic Endometritis

Conditions
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Non Specific Chronic Endometritis, Infertility, Female

Intervention / Treatment
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* Other: 16s rRNA gene sequencing


Participation Criteria
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Eligibility Criteria
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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of malignancy Pregnancy Breast feeding Perimenopause (irregular menses and FSH ≥ 20 U/l on day 3-5 of the cycle) Outdated endometrial sample from the luteal phase (this criterion will be evaluated during visit 4 post surgery) Elevated progesterone concentration ≥ 20 nmol/l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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: 16s rRNA gene sequencing|High-throughput sequencing of the microbial 16s rRNA subunit to define the abundance of microbial phyla and genera|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantity of Lactobacillus | Quantity of Lactobacillus determined by 16S ribosomal RNA gene sequencing | 1 year | 
| alpha diversity of microbes | Quantification of microbes and their diversity within the individual endometrium sample | 1 year | 
| Shannon index (Beta diversity) | Comparison of microbial diversity among the subjects | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate | Number of pregnancies within 12 months after hysteroscopy | 2 years | 
| Live Birth Rate | Number of pregnancies within 12 months after hysteroscopy | 3 years |