Clinical trial NCT05678751: Rapid Detection Method for Microorganisms in the Lower Genital Tract
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Female
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 228
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women of childbearing age who can spontaneous pregnancy and infertile women

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.


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

Primary outcomes:
measure: Lower genital tract pathogen
timeFrame: at recruitment
measure: Lower genital CST
timeFrame: at recruitment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Shenzhen Second People's Hospital
name: Zhiying Yu, M.D.
role: STUDY_CHAIR
affiliation: Shenzhen Second People's Hospital
name: Wenlan Liu, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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.
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.
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.
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.