unexplained recurrent spontaneous abortion
Conditions
Interventions
intralipid group:treating with intralipid
IVIG:treating with intralipid
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
Female
Age
20 Years to 42 Years
Inclusion criteria
Inclusion criteria: 1. Patients who had two or more miscarriages before 12th gestational week; 2. CD56+CD16+>20%; 3. Patients who signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Exclude patients who had other high-risk factors which did or might relate with recurrent spontaneous abortion, including: (1) Parental karyotype abnormalities: significant rearrangements (e.g. balanced translocations and mosaics) were considered abnormal. Other variants were considered normal. If either the patient (or her partner) had an abnormal karyotype, it was considered a parental karyotypic abnormality; (2) Genital tract abnormalities: Any congenital anatomical deformation of the genital tract was considered abnormal; intrauterine adhesions, endometriosis and hydrosalpinx were also considered abnormal; (3) alloimmune disorder: precentage of CD3+CD19+ >12%; (4) Endocrine abnormalities: prolactin (PRL) level >25 ng/ml, testosterone level >2.6 nmol/L, thyroid-stimulating hormone level 4.5 mU/L, free thyroxine (FT4) level 29.6 nmol/L and free triiodothyronine (FT3) level 7.39 nmol/L. Glucose level > 126mg/dl; (5) Autoimmune disorders: Any positive results of Anti-cardiolipin antibodies (ACA-IgG/IgM/IgA), anti-nuclear antibodies (ANA-IgG), anti-endometrium antibodies (AEA-IgM), anti-ovary antibodies (AOA-IgM), anti-sperm antibodies (ASA-IgM), antithyroidin(TG-Ab), anti-thyroid peroxidase antibody(TPO-Ab) and/or anti-chorionic gonadotropin hormone antibody; (6) Hypercoagulation state: D-dimer levels >260 ng/ml, fibrin degradation products (FDP) levels >5 mg/L or anti-ß2-glycoprotein I (anti-ß2-GP1) levels >15 U/ml; (7) Negative RH blood groups; (8) Abnormal semen routine results of patients husband. 2. Exclude patients who had serious disease that not suitable for pregnant; 3. Taking medicine which may affect NK function, such as Immunosuppressants or Glucocorticoid; 4. Patients paritcipated in other randomized clinical research within 90 days; 5. Patients could not be followed-up of a long time or had poor compliance; 6. Patients who had not been pregnant after 12 months treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| peripheral NK percentag; | — |
Countries
China
Contacts
Public ContactZhang Jianping
Outcome results
None listed