Abundance of Lactobacillus in Endometrium Affected by Chronic Endometritis

NCT04103242 | Completed

• 1 other identifier: 2017-01064 endoMB
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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).

Conditions

Non Specific Chronic Endometritis; Infertility, Female

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Pregnancy Rate

  2 years

• Live Birth Rate

  3 years

Interventions

16s rRNA gene sequencing OTHER

High-throughput sequencing of the microbial 16s rRNA subunit to define the abundance of microbial phyla and genera

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

endometrial samples swabs from Cervix uteri, vagina and uterine cavity

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Rebecca Moffat, MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: September 25, 2019
• Study Start: January 2, 2018
• Primary Completion: February 12, 2020
• Study Completion: February 28, 2021
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)