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Clinical Study on the Treatment of Immune-Related Recurrent Spontaneous Abortion with Kidney-Tonifying and Blood-Activating Therapy

Clinical Study on the Treatment of Immune-Related Recurrent Spontaneous Abortion with Kidney-Tonifying and Blood-Activating Therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000201
Enrollment
Unknown
Registered
2025-01-28
Start date
2024-04-26
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Deficiency and Blood Stasis Type Immune-Related Recurrent Spontaneous Abortion

Interventions

control group:After being included in this study participants began to take low molecular weight heparin: Fraxiparine 0.4ml subcutaneous injection once daily (qd) from the 5th week of pregnancy until
observation group:After being included in this study participants began taking Anzi Diaochong Tang starting from the 5th week of pregnancy until the end of the 11th week then discontinued the medicati

Sponsors

Shenzhen Maternity & Child Healthcare Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Meets the diagnostic criteria for immune-related recurrent miscarriage and is identified as having kidney deficiency and blood stasis syndrome 2. The current pregnancy is either natural conception or resulting from IVF-ET (In Vitro Fertilization-Embryo Transfer) 3. Age is between 20 and 40 years old 4. FSH (Follicle Stimulating Hormone) level is =10 mIU/L during the follicular phase 5. Immunological factors in RSA (Recurrent Spontaneous Abortion) are either autoimmune or allogeneic 6. Have signed an informed consent form 7. Are capable of stable follow-up 8. Are willing to accept treatment with traditional Chinese medicine or immunosuppressive agents

Exclusion criteria

Exclusion criteria: 1. Combined with uterine structural abnormalities congenital pre-thrombotic state and endocrine dysfunction. 2. Those with a history of severe drug allergies. 3. With genetic factors such as recurrent miscarriage caused by chromosomal abnormalities in one of the spouses. 4. Recurrent miscarriage caused by infectious factors.

Design outcomes

Primary

MeasureTime frame
Human Chorionic Gonadotropin;Tolerogenic Dendritic Cells (tolDCs) Detection;Progesterone;CD86 molecule detection;Forkhead box P3;CD83 molecule detection;Estradiol;Transforming Growth Factor-beta;Tumor Necrosis Factor-alpha;FOXP3+ Regulatory T Cell Detection;CD80 molecule detection;

Secondary

MeasureTime frame
Immunoglobulin A;Complement 4;Rheumatoid factor;Total T cells (CD3+);Anti-Cardiolipin Antibody IgG;Anti-beta 2 Glycoprotein I IgG;Anti-RNP70 IgG;Protein S;Activated Partial Thromboplastin Time;CD3+CD4+ T cells;Anti-Nuclear Antibody;C-reactive protein;D-Dimer;Immunoglobulin G;Fibrinogen;Prothrombin Time;Complement 3;anti-SSB antibody;CD4/CD8 Ratio;Anti-beta 2 Glycoprotein I IgA;Anti-beta 2 Glycoprotein I IgM;CD3+CD8+ T cells;Homocysteine;B-lymphocytes (CD19+);Protein C;Anti-Streptolysin O;Natural killer (CD16+56+, CD3-);Anti-Cardiolipin Antibody IgM;Anti-Cardiolipin Antibody IgA;Thrombin Time;Anti-double stranded DNA antibody, IgG;Immunoglobulin M;Anti-Smith (Sm) Antibody, IgG;anti-SSA antibody;

Countries

China

Contacts

Public ContactMa Fei

Shenzhen Maternity & Child Healthcare Hospital

593529863@qq.com18898607015

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026