Abundance of Lactobacillus in Endometrium Affected by Chr... | NCT04103242

Studies
Abundance of Lactobacillus in Endometrium Affected by Chronic Endometritis

NCT04103242

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Dec 4, 2024Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Non Specific Chronic Endometritis
Infertility, Female

Interventions

16s rRNA gene sequencing

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2018Actual

Primary Completion Date

Feb 12, 2020Actual

Completion Date

Feb 28, 2021Actual

First Submitted Date

Oct 31, 2018

First Submission Date that Met QC Criteria

Sep 24, 2019

First Posted Date

Sep 25, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2024

Last Update Posted Date

Dec 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

23Actual

Name	Type	Description	Arm Group Labels	Other Names
16s rRNA gene sequencing	Other	High-throughput sequencing of the microbial 16s rRNA subunit to define the abundance of microbial phyla and genera

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases