- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06296615
Whether Vaginal Microbiota Affects Pregnancy Outcomes After Embryo Transfer
Study Overview
Status
Conditions
Detailed Description
Despite clinicians' efforts to optimize clinical protocols in assisted reproduction, the clinical pregnancy rate continues to be unsatisfactory. Microbial dysbiosis has been implicated in numerous adverse reproductive conditions. The examination of microorganisms remains a promising avenue for improving clinical outcomes following embryo transfer in in-vitro fertilization (IVF) centers.
The vagina serves as the primary barrier, separating the external environment from the upper reproductive tract. Recent studies employing deep sequencing of microorganisms in IVF patients have shed light on the association between the diversity of vaginal microbiota and the abundance of specific microorganisms with crucial reproductive outcomes. However, certain studies have yielded inconsistent results, suggesting either no discernible association between vaginal microbiota and IVF outcomes or varying disparities in bacterial composition between groups with favorable and unfavorable clinical outcomes. Research into predictive models based on reproductive tract microbiota remains relatively limited. Hence, further studies are warranted to elucidate the correlation between vaginal microorganisms and pregnancy outcomes.
The aim of this study is to explore the characteristics of vaginal microbiota in patients undergoing IVF treatment and examine potential differences between those who achieve pregnancy and those who do not. Patients will be asked to complete a questionnaire regarding their basic characteristics, and vaginal secretions will be collected via vaginal swab during frozen-blastocyst transfer procedures. High-throughput sequencing of the V3-V4 variable region of the 16S rRNA gene will be conducted on the vaginal secretions of participants. Specifically, investigators will: (1) compare Alpha diversity between the two groups; (2) compare Beta diversity between the two groups; (3) investigate whether there are any differences in specific bacterial taxa between the two groups; (4) determine the favorable or unfavorable profiles of vaginal microbiota associated with achieving pregnancy; and (5) explore methods for predicting pregnancy outcomes based on vaginal microbiota. This study presents a prospective approach to utilizing microbial characteristics for predicting pregnancy outcomes before implementing further interventions, offering potential refinement of treatment strategies for IVF patients.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Shanghai, China
- Shanghai Ji Ai Genetics & IVF Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Woman of 20-40 years of age
- Woman who have regular menstrual cycles and normal level of E2, P, FSH, LH, T, RPL in the early follicular phase
- Women who are scheduled for PGT cycles in IVF center and have a euploid blastocyst to transfer
- Women who have normal uterine and adnexal ultrasonography
Exclusion Criteria:
- embryos underwent double vitrification or a second biopsy
- patients having premature ovarian insufficiency (FSH > 12 mIU/ml and AMH < 1.1 ng/ml), abnormal uterine cavity, systemic disease, endometriosis American Fertility Score III/IV, or cancer
- those testing positive for mold spores or trichomonas in vaginal secretion examination and subjectively reported abnormal vaginal symptoms such as vaginal itching at 7 days before embryo transfer
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of clinical pregnancy
Time Frame: 4 weeks after embryo transfer for the patient
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Clinical pregnancy is defined as the presence of a gestational sac confirmed by transvaginal ultrasound examination.
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4 weeks after embryo transfer for the patient
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Collaborators and Investigators
Investigators
- Study Director: Yijuan Sun, Ph.D, Shanghai Ji Ai Genetics & IVF Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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