Rapid Detection Method for Microorganisms in the Lower Genital Tract

Not yet recruiting

• Conditions: Infertility, Female
• Interventions: Diagnostic Test: lower genital tract microorganisms detection using Matrix-Assisted Laser Desorption/Ionization Time of Flight Mass Spectrometry (MALDI-TOF MS)

• Registration Number: NCT05678751
• Lead Sponsor: Shenzhen Second People's Hospital

Brief Summary

Mycoplasma, chlamydia, and gonococcal infection of the female lower genital tract can lead to infertility and various adverse pregnancy outcomes. The lower genital tract bacterial community status type (CST) is closely related to genital tract infection and reproductive health. However, there is a need for a rapid, accurate, stable, and economical detection method to detect the above pathogens and CST at the same time, so there is also a need for evaluation of the correlation between each pathogen infection and CST. Matrix assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) is more stable and accurate than traditional detection methods such as culture and staining. It can simultaneously detect a variety of microorganisms and their subtypes, while the high-throughput sequencing method is faster and more economical, which is suitable for detecting multiple microorganisms in clinical practice. The research group has established a perfect MALDI-TOF MS platform in the early stage and put it into clinical testing. This project will establish a new rapid detection method for lower genital tract microorganisms based on MALDI-TOF MS. Then, examine the lower genital tract microecology of infertile patients and healthy women using the newly developed method. At last, analyze the correlation between pathogen infection, CST status, and infertility. This project will solve the practical work needs of clinicians for a comprehensive assessment of female lower genital tract CST and common pathogen infection and fill in the technical gaps in the microbial examination of the lower genital tract.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-12-23
• Study First Submitted QC: 2022-12-23
• Last Update Submitted: 2022-12-23
• Study Start: 2023-01
• Study First Posted: 2023-01-10
• Last Update Posted: 2023-01-10
• Primary Completion: 2024-09-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 228

Inclusion Criteria

Case group:

1. Female aged 18-40 2) Regular menstrual cycle 2) Conform to the clinical diagnosis of infertility 3) No sexual life 3 days before the examination control group:

1. Female aged 18-40
2. Regular menstrual cycle
3. Patients who did pre-pregnancy consultation in our hospital, pregnant at the time of 3-month follow-up
4. No sexual life 3 days before the examination -

Exclusion Criteria

Case group:

1. Infertility due to malformation of reproductive tract
2. Infertility caused by endocrine factors such as polycystic ovary syndrome, premature ovarian failure and severe hyperthyroidism
3. Infertility due to male factors
4. Patients with malignant tumors
5. Patients with autoimmune diseases
6. Patients with severe heart, kidney and other basic diseases
7. Patients who consumed antibiotics 3 days before the examination
8. Have the habit of smoking and drinking

Control group:

1. Pregnancy by various assisted reproductive means
2. Patients with malignant tumors
3. Patients with autoimmune diseases
4. Patients with severe heart, kidney and other basic diseases
5. Patients who consumed antibiotics 3 days before the examination
6. Have the habit of smoking and drinking

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
case group	lower genital tract microorganisms detection using Matrix-Assisted Laser Desorption/Ionization Time of Flight Mass Spectrometry (MALDI-TOF MS)	patients with infertility
control group	lower genital tract microorganisms detection using Matrix-Assisted Laser Desorption/Ionization Time of Flight Mass Spectrometry (MALDI-TOF MS)	women that are capable of spontaneous intrauterine pregnanc

Primary Outcome Measures

Name	Time	Method
Lower genital CST	at recruitment	Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus iners, Lactobacillus jensenii
Lower genital tract pathogen	at recruitment	Ureaplasma urealyticum, mycoplasma hominis, chlamydia antigen, gonococcus