Abundance of Lactobacillus in Endometrium Affected by Chronic Endometritis

Infertility, Female Clinical Trial

— endoMB  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04103242
• Other study ID #: 2017-01064 endoMB
• Status: Not yet recruiting
• Start date: July 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2020
• Source: University Hospital, Basel, Switzerland
• Contact: Rebecca Moffat, MD
• Phone: +41 67 328 79 80
• Email: rebecca.moffat[@]usb.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometritis
• Infertility
• Infertility, Female
• Non Specific Chronic Endometritis

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantity of Lactobacillus	Quantity of Lactobacillus determined by 16S ribosomal RNA gene sequencing	1 year
Primary	alpha diversity of microbes	Quantification of microbes and their diversity within the individual endometrium sample	1 year
Primary	Shannon index (Beta diversity)	Comparison of microbial diversity among the subjects	1 Year
Secondary	Pregnancy Rate	Number of pregnancies within 12 months after hysteroscopy	2 years
Secondary	Live Birth Rate	Number of pregnancies within 12 months after hysteroscopy	3 years