Abundance of Lactobacillus in Endometrium Affected by Chronic Endometritis

Completed

• Conditions: Infertility, Female; Non Specific Chronic Endometritis

• Registration Number: NCT04103242
• Lead Sponsor: University Hospital, Basel, Switzerland

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-02
• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-25
• Primary Completion: 2020-02-12
• Study Completion: 2021-02-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

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• Outdated endometrial sample from the luteal phase (this criterion will be evaluated during visit 4 post surgery)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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland