Infertility, FemaleNCT05678751
Rapid Detection Method for Microorganisms in the Lower Genital Tract
An observational study of Infertility, Female, run by Shenzhen Second People's Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- lower genital tract microorganisms detection using Matrix-Assisted Laser Desorption/Ionization Time of Flight Mass Spectrometry (MALDI-TOF MS)
- How many people
- 228 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women of childbearing age who can spontaneous pregnancy and infertile women
Who may be able to join
- 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:
- 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 -
Who cannot join
- 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
Show all 16Show fewer
- 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
- Have the habit of smoking and drinking
Trial locations and contacts
No sites are listed yet.
About this study
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
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
- Being tested
- lower genital tract microorganisms detection using Matrix-Assisted Laser Desorption/Ionization Time of Flight Mass Spectrometry (MALDI-TOF MS)
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| case group | patients with infertility Receives: 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 Receives: Diagnostic Test: lower genital tract microorganisms detection using Matrix-Assisted Laser Desorption/Ionization Time of Flight Mass Spectrometry (MALDI-TOF MS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower genital tract pathogen
Ureaplasma urealyticum, mycoplasma hominis, chlamydia antigen, gonococcus
Measured: at recruitment
Lower genital CST
Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus iners, Lactobacillus jensenii
Measured: at recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study startJan 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Second People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhiying Yu, M.D., Study chair, Shenzhen Second People's HospitalWenlan Liu, PhD, Study director, Shenzhen Second People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678751
- Sponsor's protocol ID
- yzy_00159
- Status last verified
- Jul 2022
- First submitted
- 23 Dec 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 28209488Carey 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.
PubMed 20192953Chee 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.
PubMed 33160356Smith 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.
PubMed 27373840Dunlop 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.
PubMed 33996627
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05678751
- Acronym / sponsor ID
- yzy_00159
- Conditions
- Infertility, Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Shenzhen Second People's HospitalUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| case group | – | Diagnostic Test: lower genital tract microorganisms detection using Matrix-Assisted Laser Desorption/Ionization Time of Flight Mass Spectrometry (MALDI-TOF MS)patients with infertility |
| control group | – | 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women of childbearing age who can spontaneous pregnancy and infertile women
Key inclusion criteria (6 listed)
- 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:
- 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 -
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | case group, control group |
Primary outcome
Lower genital tract pathogen
Time frame: at recruitment
Ureaplasma urealyticum, mycoplasma hominis, chlamydia antigen, gonococcus
Lower genital CST
Time frame: at recruitment
Lactobacillus crispatus, Lactobacillus gasseri, Lactobacillus iners, Lactobacillus jensenii
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Background: PubMed 28209488Chen 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.
- Background: PubMed 20192953Carey 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.
- Background: PubMed 33160356Chee 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.
- Background: PubMed 27373840Smith 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.
- Background: PubMed 33996627Dunlop 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhiying Yu, M.D. study chair
Shenzhen Second People's Hospital
Wenlan Liu, PhD study director
Shenzhen Second People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female, run by Shenzhen Second People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Chen, M.D. (+86 0755 83366388 ext. 3048, chenyu2017@email.szu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower genital tract pathogen (time frame: at recruitment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05678751, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.