Rapid Detection Method for Microorganisms in the Lower Genital Tract

NCT ID: NCT05678751

Last Updated: 2023-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 228 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2024-12-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

case group

patients with infertility

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

Intervention Type: 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

control group

women that are capable of spontaneous intrauterine pregnanc

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

Intervention Type: 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

Interventions

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

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shenzhen Second People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhiying Yu, M.D.

Role: STUDY_CHAIR

Shenzhen Second People's Hospital

Wenlan Liu, PhD

Role: STUDY_DIRECTOR

Shenzhen Second People's Hospital

Central Contacts

Yu Chen, M.D.

Role: CONTACT

chenyu2017@email.szu.edu.cn

+86 0755 83366388 ext. 3048

References

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.

Reference Type: BACKGROUND

PMID: 28209488 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20192953 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33160356 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27373840 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33996627 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

yzy_00159

Identifier Type: -

Identifier Source: org_study_id