unexplained recurrent pregnancy loss
Conditions
Interventions
Intervention group:rhG-CSF+aspirin+progesterone
Control group:placebo+aspirin+progesterone
Sponsors
The second hospital of Lanzhou University
Eligibility
Sex/Gender
Female
Age
20 Years to 37 Years
Inclusion criteria
Inclusion criteria: (1)Age of 20 to 37 years old (the reason for setting the upper age limit of 37 years old is that abortion caused by chromosomal aberrations has a higher incidence in advanced maternal age, and cannot be prevented by immunological regulation);(2)Body mass index (BMI) between 15 to 29 at screening(Mean±SD of out-patients from two centers in the past 2 years);(3)Menstrual cycle within 21-35 days,and the difference between the longest cycle and the shortest cycle only in 1 year is no more than 7 days;(4)History of recurrent pregnancy loss, defined as two or more fetal losses before 24 weeks of gestation (including biochemical pregnancy);(5)Willingness to conceive spontaneously and signing of informed consent form.
Exclusion criteria
Exclusion criteria: (1)Gestational age > 5 weeks + 6 days;(2)Chromosomal abnormalities in females or their partners;(3)Patients previously diagnosed with infertility (no conception after regular sexual life without any contraception for at least 1 year);(4)Exclusion of immunological 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 and hyperhomocysteinemia, etc.]; anatomical factors including congenital anatomical abnormalities [mediastinal uterus, bicornuate uterus, arcuate uterus, unicornuate uterus, duplex uterus, uterine dysplasia and congenital cervical insufficiency, etc.] and acquired anatomical abnormalities [Asherman syndrome, cervical insufficiency, adenomyosis, uterine fibroids, etc.]; endocrine factors [polycystic ovary syndrome (PCOS), luteal phase dysfunction, hyperprolactinemia (HPRL), thyroid disease requiring drug treatment, diabetes, etc.] and other medical history;(5)Combination of the following diseases with uncontrolled symptoms: asthma, hypertension, infection;(6)Present with the following laboratory abnormalities at screening or within the first 3 months: platelet decreased or increased (platelet count 500,000/µL); neutrophil decreased or increased (absolute neutrophil count 10,000/µL), white blood cell decreased or increased (white blood cell count 15,000/µL), and creatinine, alanine aminotransferase, aspartate aminotransferase, lactate dehydrogenase, alkaline phosphatase, or uric acid > 1.5 times of the upper limit of normal;(7)Allergy to granulocyte colony-stimulating factor or any component of the injection;(8)History of granulocyte colony-stimulating factor use within the past 3 months;(9)Other contraindications to the use of investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24 weeks live birth rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| early pregnancy loss rate;clinically confirmed pregnancy rate;ongoing pregnancy rate(to 10 weeks);ongoing pregnancy rate(to 12 weeks);28 weeks live birth rate;ectopic pregnancy rate;stillbirth rate;incidence rate of pregnancy complications;neonatal weigh;neonatal Apgar score;neonatal birth defect rate;incidence rate of adverse effect; | — |
Countries
China
Contacts
Public ContactFang Wang
The second hospital of Lanzhou University
Outcome results
None listed