Thyroid autoimmune abnormalities combined with recurrent miscarriage
Conditions
Interventions
Treatment with LT4 alone:Treatment with LT4 alone
LT4 treatment + Qianjin Baoyun Pills:LT4 treatment + Qianjin Baoyun Pills
Sponsors
The Third Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 42 Years
Inclusion criteria
Inclusion criteria: 1. Positive thyroid autoantibodies (TPOAb) and/or positive (TGAb); 2. History of recurrent abortion (2 or more spontaneous abortions, termination of pregnancy at less than 28 weeks of gestation, including biochemical pregnancies); 3. Meets the traditional Chinese medicine diagnostic criteria for threatened miscarriage due to qi and blood deficiency. Main symptom: two or more spontaneous abortions. Secondary symptoms: fatigue; dizziness; scanty and pale menstrual flow; shortness of breath and reluctance to speak; palpitations; insomnia; pale complexion and pale lips/nail beds. Meets the above main symptom and any two of the secondary symptoms; 4. Aged 20-42, with reproductive needs, 18.5 = BMI = 28kg/m2. (Note: the ovarian function of women in the age group of 20-42 years is mostly normal, below the age of 20 years is not up to the legal age for women to get married, and over the age of 42 years, the ovarian function declines, and the risk increases).
Exclusion criteria
Exclusion criteria: 1.Thyroid diseases other than atrophic thyroiditis and Hashimoto's disease: e.g. Graves' disease, subthyroiditis, transient hyperthyroidism, severe mucous oedema, thyroid cancer or those with a high degree of suspicion of thyroid carcinoma (thyroid nodules with ultrasound TI-RADS grading of 4b or more), acute secondary hyperthyroidism or hypothyroidism in the postpartum period, hypothyroxinemia, thyroid pathology syndrome; 2.Other causes of TSH elevation, including TSH test interference, recovery from low T3 syndrome, central hypothyroidism leading to abnormal thyroid function (hypothalamic lesions, pituitary lesions), renal insufficiency, glucocorticoid deficiency, and physiologic adaptation; 3.FSH = 20 IU/L in two early follicular phases; 4.Chromosomal or genetic abnormalities; 5.Abnormalities of uterine anatomy and cervical insufficiency, such as congenital uterine malformations, untreated uterine adhesions, untreated tubal blockage, uterine fibroids, adenomyosis, and endometriosis; 6.Combination of other autoimmune diseases, such as systemic lupus erythematosus, dry syndrome, rheumatoid arthritis, systemic sclerosis; 7.Other endocrine factors: patients with endocrine metabolic disorders such as untreated hyperprolactinemia (PRL abnormalities), luteal insufficiency, uncontrolled diabetes mellitus (HbA1c = 7.0%), and polycystic ovary syndrome without metabolic modification (without restoration of normal ovulation); 8.The result of untreated infectious factors; 9.Due to male factor; 10.hose who have bad habits such as smoking, alcoholism, or those who have been in a highly radioactive environment or exposed to certain chemicals (pesticides, lead, arsenic, mercury, etc.) for a long period of time; 11.Combined serious primary diseases of the heart, brain, liver, kidney, endocrine, hematopoietic and immune systems (including those with blood ALT and AST > 2.0 times the upper limit of normal, and those with blood creatinine (Cr) > 2.5 times the upper limit of normal); 1.or other serious diseases affecting their survival, such as malignant neoplasms; 2.or those who are not able to cooperate with the study, such as those who are psychiatrically or intellectually abnormal; 12.Allergy or known hypersensitivity to the drugs and ingredients used in this study; 13.Patients who, in the opinion of the investigator, are not suitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spontaneous abortion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical pregnancy rate;live birth rate;Spontaneous abortion rate in early pregnancy;Incidence of adverse pregnancy outcomes;Neonatal scoring;TPOAb;TgAb titer level;TSH;FSH;AMH;LH;Relevant Laboratory Indicators (Coagulation Indicators, Immuno-antibodies);Score of Chinese Medicine Symptoms;Thy39 self-assessment questionnaire; | — |
Countries
China
Contacts
Public ContactYing Zhang
The Third Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed