An observational study in Infertility, Female, sponsored by Shenzhen Second People's Hospital. Status unknown. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-10.
Sponsored by Shenzhen Second People's Hospital · Observational
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 228 is above the median of 200 across 714 observational studies indexed under Infertility.
Browse Infertility studies →Shenzhen Second People's Hospital is the lead sponsor of 48 studies on the registry; 8 are open to participants now.
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Women of childbearing age who can spontaneous pregnancy and infertile women
Case group:
Exclusion Criteria:
Case group:
Control 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)
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)
Detection of pathogens and microorganisms in the lower genital tract of infertile and spontaneously pregnant women by a new MALDI-TOF MS-based technique
Lower genital tract pathogen
Ureaplasma urealyticum, mycoplasma hominis, chlamydia antigen, gonococcus
Time frame: at recruitment
Lower genital CST
Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus iners, Lactobacillus jensenii
Time frame: at recruitment
No study locations are listed for this record.
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Plan to share: Undecided — Because this study involves private information related to patient reproduction, we may not fully disclose subject details, but we will evaluate applicants and give non-private data by email, etc., when necessary.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Shenzhen Second People's Hospital