Abundance of Lactobacillus in Endometrium Affected by Chronic Endometritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-02

Study Completion Date

2021-02-28

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).

Detailed Description

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Conditions

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Non Specific Chronic Endometritis Infertility, Female

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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16s rRNA gene sequencing

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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rebecca Moffat, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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2017-01064 endoMB

Identifier Type: -

Identifier Source: org_study_id