Rapid Detection Method for Microorganisms in the Lower Genital Tract

NCT05678751 | Unknown

• 1 other identifier: yzy_00159
• Study Type: observational
• Target: 228
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (2)

• Lower genital tract pathogen

  Ureaplasma urealyticum, mycoplasma hominis, chlamydia antigen, gonococcus

  at recruitment

• Lower genital CST

  Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus iners, Lactobacillus jensenii

  at recruitment

Study Arms (2)

case group

patients with infertility

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

control group

women that are capable of spontaneous intrauterine pregnanc

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

Interventions

lower genital tract microorganisms detection using Matrix-Assisted Laser Desorption/Ionization Time of Flight Mass Spectrometry (MALDI-TOF MS) DIAGNOSTIC_TEST

Detection of pathogens and microorganisms in the lower genital tract of infertile and spontaneously pregnant women by a new MALDI-TOF MS-based technique

case group; control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: The target disease of this study is infertility, so its not based on self-representation of gender identity
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women of childbearing age who can spontaneous pregnancy and infertile women

You may qualify if:

• Case group:
• \) 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:
• Female aged 18-40
• Regular menstrual cycle
• Patients who did pre-pregnancy consultation in our hospital, pregnant at the time of 3-month follow-up
• No sexual life 3 days before the examination -

You may not qualify if:

• Case group:
• Infertility due to malformation of reproductive tract
• Infertility caused by endocrine factors such as polycystic ovary syndrome, premature ovarian failure and severe hyperthyroidism
• Infertility due to male factors
• Patients with malignant tumors
• Patients with autoimmune diseases
• Patients with severe heart, kidney and other basic diseases
• Patients who consumed antibiotics 3 days before the examination
• Have the habit of smoking and drinking
• Control group:
• Pregnancy by various assisted reproductive means
• Patients with malignant tumors
• Patients with autoimmune diseases
• Patients with severe heart, kidney and other basic diseases
• Patients who consumed antibiotics 3 days before the examination

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead

Related Publications (5)

• Chen YJ, Hsu TF, Huang BS, Tsai HW, Chang YH, Wang PH. Postoperative maintenance levonorgestrel-releasing intrauterine system and endometrioma recurrence: a randomized controlled study. Am J Obstet Gynecol. 2017 Jun;216(6):582.e1-582.e9. doi: 10.1016/j.ajog.2017.02.008. Epub 2017 Feb 15.

  PMID: 28209488 BACKGROUND

• Carey AJ, Beagley KW. Chlamydia trachomatis, a hidden epidemic: effects on female reproduction and options for treatment. Am J Reprod Immunol. 2010 Jun;63(6):576-86. doi: 10.1111/j.1600-0897.2010.00819.x. Epub 2010 Feb 28.

  PMID: 20192953 BACKGROUND

• Chee WJY, Chew SY, Than LTL. Vaginal microbiota and the potential of Lactobacillus derivatives in maintaining vaginal health. Microb Cell Fact. 2020 Nov 7;19(1):203. doi: 10.1186/s12934-020-01464-4.

  PMID: 33160356 BACKGROUND

• Smith SB, Ravel J. The vaginal microbiota, host defence and reproductive physiology. J Physiol. 2017 Jan 15;595(2):451-463. doi: 10.1113/JP271694. Epub 2016 May 5.

  PMID: 27373840 BACKGROUND

• Dunlop AL, Satten GA, Hu YJ, Knight AK, Hill CC, Wright ML, Smith AK, Read TD, Pearce BD, Corwin EJ. Vaginal Microbiome Composition in Early Pregnancy and Risk of Spontaneous Preterm and Early Term Birth Among African American Women. Front Cell Infect Microbiol. 2021 Apr 29;11:641005. doi: 10.3389/fcimb.2021.641005. eCollection 2021.

  PMID: 33996627 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Vaginal and cervical secretions

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Zhiying Yu, M.D.

  Shenzhen Second People's Hospital

  STUDY CHAIR

• Wenlan Liu, PhD

  Shenzhen Second People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Yu Chen, M.D.

CONTACT

+86 0755 83366388; chenyu2017@email.szu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 10, 2023
• Study Start: January 1, 2023
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 10, 2023

Record last verified: 2022-07