Abundance of Lactobacillus in Endometrium Affected by Chronic Endometritis (endoMB)

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility, Female; Non Specific Chronic Endometritis
• Intervention / Treatment: Other: 16s rRNA gene sequencing

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Rebecca Moffat, MD; Phone Number: +41 67 328 79 80; Email: rebecca.moffat@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • University Hospital Basel
    • Contact: Rebecca E Moffat, MD; Phone Number: +41 61 328 79 80; Email: rebecca.moffat@usb.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting at the Clinic for Reproductive Medicine of the University Hospital Basel because of infertility with an indication for HSC represent the project population.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Rebecca Moffat, MD, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: June 9, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases; Adnexal Diseases; Pelvic Inflammatory Disease; Infertility; Infertility, Female; Endometritis
• Other Study ID Numbers: 2017-01064 endoMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No