Unexplained Recurrent Spontaneous Abortion
Conditions
Interventions
Experimental Group:G-CSF (Filgrastim, product of Kirin Kunpeng [China] Pharmaceuticals Co., Ltd., 75µg/0.3ml per vial) is administered at a dose of 150µg (equivalent to two vials). Administration begi
Control Group:Administration of an equivalent volume/dose of placebo begins on the day of a positive ovulation test, followed by injections every other day until 9 weeks of gestation. Additionally, dy
Sponsors
Women's Hospital School of Medicine Zhejiang University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. A history of three or more spontaneous pregnancy losses, including biochemical pregnancies, with at least one loss confirmed by normal embryonic chromosomal analysis; 2. Age between 20 and 40 years (inclusive); 3. In good general health, voluntarily agrees to participate in this trial, is willing to comply with the treatment regimen and follow-up visits, and has provided written informed consent
Exclusion criteria
Exclusion criteria: 1. Presence of any known etiological factor for miscarriage, including chromosomal or genetic abnormalities in either partner, uterine anomalies, autoimmune diseases (e.g., systemic lupus erythematosus, antiphospholipid syndrome, Sjögren’s syndrome), thrombophilia (e.g., protein S deficiency, protein C deficiency, antithrombin deficiency, hereditary or acquired hyperhomocysteinemia), endocrine disorders (e.g., diabetes mellitus, thyroid dysfunction, hyperprolactinemia, luteal phase defect, polycystic ovary syndrome), or an acute infection requiring treatment; 2. Known allergy to granulocyte colony-stimulating factor or other agents derived from Escherichia coli; 3. Severe impairment of hepatic, renal, cardiac, or pulmonary function.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live Birth Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Miscarriage Rate;Biochemical Pregnancy Rate;Clinical Pregnancy Rate;Rate of Pregnancy Complications;Gestational Age at Delivery;Sex of the Newborn;Birth Weight;Apgar Score at 1 Minute;Apgar Score at 5 Minutes;Rate of Birth Defects;Ongoing Clinical Pregnancy Rate; | — |
Countries
China
Contacts
Public ContactDan Zhang
Women's Hospital, School of Medicine, Zhejiang University
Outcome results
None listed