Unexplained Recurrent Spontaneous Abortion
Conditions
Interventions
URSA preconception prospective cohort:None
Sponsors
Shanghai Institute for Biomedical and Pharmaceutical Technologies
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.Female aged 20–40 years; 2.Current pregnancy diagnosed as a missed miscarriage with gestational age <=12 weeks, with termination of pregnancy by vacuum aspiration; 3.Meeting the diagnostic criteria for URSA: a history of two or more consecutive pregnancy losses before 28 weeks of gestation with the same partner, confirmed by ultrasound or histology, with no identifiable cause after completion of key investigations recommended by relevant consensus statements or clinical guidelines; 4.Planning to conceive again within one year; 5.No sexual intercourse, vaginal douching, or vaginal medication in the past 72 hours; 6.Normal development of the reproductive system, with no organic uterine lesions or related comorbidities; 7.Provision of written informed consent and agreement to complete follow-up visits and sample collection at multiple time points;
Exclusion criteria
Exclusion criteria: 1.Use of antibiotics, probiotics/synbiotics, systemic hormones, or immunosuppressants within the past month; 2.Active periodontitis, inflammatory bowel disease, acute reproductive tract infection, or other conditions that may significantly affect the systemic microbiome; 3.Severe systemic diseases involving major organs, such as the heart, liver, kidneys, etc;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Key cytokine profiles in serum/vaginal secretions;Microbiota profiling of the gut, vagina, and oral cavity;Serum metabolomics;Miscarriage rate in subsequent pregnancies;Peripheral blood immune cells; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subsequent pregnancy rate;Time to pregnancy (TTP); | — |
Countries
China
Contacts
Public ContactChe Yan
Shanghai Institute for Biomedical and Pharmaceutical Technologies
Outcome results
None listed