unexplained recurrent pregnancy loss
Conditions
Interventions
Control group:0.9% Sodium Chloride Injection 0.5ml/d
Intervention group:Recombinant Human Granulocyte Stimulating Factor Injection 0.5ml/d
Sponsors
The second hospital of Lanzhou University
Eligibility
Sex/Gender
Female
Age
20 Years to 37 Years
Inclusion criteria
Inclusion criteria: (1) The age ranged from 20 to 37 years old (the upper age limit of 37 years was set because the abortion caused by chromosome aberration had a high incidence in elderly pregnant women, and the abortion caused by this reason could not be prevented by immune regulation); (2) Body mass index (BMI) at screening was between 19 and 35; (3) Menstrual cycle; (4) A history of recurrent pregnancy loss, defined as 2 or more fetal losses before 24 weeks of gestation (confirmed by ultrasound or pathological biopsy); (5) Have the will to conceive naturally.
Exclusion criteria
Exclusion criteria: (1) Gestational age is more than 5 weeks; (2) Chromosome abnormality of female or her spouse; (3) Diagnosed as infertility; (4) Exclude immune factors (including autoimmune diseases: antiphospholipid syndrome, systemic lupus erythematosus, undifferentiated connective tissue disease, Sjogren's syndrome, rheumatoid arthritis and systemic sclerosis); Thrombophilia (anticoagulant protein C, S deficiency, antiphospholipid syndrome, hyperhomocysteinemia, etc.); Anatomical factors include congenital anatomical abnormalities (mediastinal uterus, double horn uterus, arched uterus, single horn uterus, double uterus, uterine dysplasia and congenital cervical insufficiency) and acquired anatomical abnormalities (Asherman syndrome, cervical insufficiency, hysteromyoma, etc.); Endocrine factors (polycystic ovary syndrome (PCOS), luteal insufficiency, hyperprolactinemia (hPRL), abnormal thyroid function, abnormal glucose metabolism, etc.); (5) combined with the following diseases and symptoms are not yet controlled: asthma, type II diabetes, hypertension and infection; (6) The following laboratory findings were abnormal during screening or within the first 3 months: thrombocytopenia or increase (platelet count 500000/ µ L) Neutropenia or increase (absolute neutrophil count 10000/u50) , leucopenia or increase (leucocyte count 15000/u50) , creatinine, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, alkaline phosphatase or uric acid > 1.5 times of the upper limit of normal; (7) Allergic to granulocyte colony stimulating factor or any component in the injection; (8) There was a history of granulocyte colony stimulating factor use in the past 3 months; (9) There are contraindications to the use of other test drugs.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28 week live birth rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| pregnancy outcome;fetal outcome; | — |
Countries
China
Contacts
Public ContactFang Wang
The second hospital of Lanzhou University
Outcome results
None listed