Rapid Detection Method for Microorganisms in the Lower Genital Tract

Infertility, Female Clinical Trial

Official title:

Establishment of a Rapid Detection Method for Microorganisms in the Lower Genital Tract Using MALDI-TOF MS and Its Clinical Application in Infertility

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05678751
• Other study ID #: yzy_00159
• Status: Not yet recruiting
• Start date: January 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2022
• Source: Shenzhen Second People's Hospital
• Contact: Yu Chen, M.D.
• Phone: +86 0755 83366388
• Email: chenyu2017[@]email.szu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 228
• Est. completion date: December 31, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shenzhen Second People's Hospital

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lower genital tract pathogen	Ureaplasma urealyticum, mycoplasma hominis, chlamydia antigen, gonococcus	at recruitment
Primary	Lower genital CST	Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus iners, Lactobacillus jensenii	at recruitment