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OpenTrials
Completed

NCT Number: NCT04103242

Abundance of Lactobacillus in Endometrium Affected by 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).

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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  • Outdated endometrial sample from the luteal phase (this criterion will be evaluated during visit 4 post surgery)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

Treatment and study plan

16s rRNA gene sequencing

Other

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

Primary outcomes

  1. Quantity of Lactobacillus

    Time frame: 1 year

    Quantity of Lactobacillus determined by 16S ribosomal RNA gene sequencing

  2. alpha diversity of microbes

    Time frame: 1 year

    Quantification of microbes and their diversity within the individual endometrium sample

  3. Shannon index (Beta diversity)

    Time frame: 1 Year

    Comparison of microbial diversity among the subjects

Secondary outcomes

  1. Pregnancy Rate

    Time frame: 2 years

    Number of pregnancies within 12 months after hysteroscopy

  2. Live Birth Rate

    Time frame: 3 years

    Number of pregnancies within 12 months after hysteroscopy

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: endoMB

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Sep 25, 2019
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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