Skip to content

Study of cyclosporine in improving the prognosis of recurrent pregnancy with unexplained recurrent spontaneous abortion

Study of cyclosporine in improving the prognosis of recurrent pregnancy with unexplained recurrent spontaneous abortion

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031716
Enrollment
Unknown
Registered
2020-04-08
Start date
2020-05-11
Completion date
Unknown
Last updated
2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

unexplained recurrent spontaneous abortion

Interventions

experimental group:Cyclosporine

Sponsors

Obstetrics & Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: The subjects should meet all of the following criteria before they can participate in this study. 1. Healthy, willing to participate in this study, willing to take medication and follow-up according to plan, and willing to sign the informed consent; 2. Aged 20-40 and consistented with a history of unexplained recurrent abortion; 3. The test of hcg in urine was positive after the couple have sexual intercourse for 14 days; 4. TORCH IgM (-); 5. The antibody of blood type for ABO <1: 128, for RH is normal; 6. Hysteroscopy or H.S.G: At least one side of the fallopian tube is unobstructed, and the shape of uterine cavity is normal whatever through ways of surgery, medication and other means; 7. The test of routine semen examination for husband is basically normal or normal fertilization after treatment; 8. The karyotype of the couple is normal.

Exclusion criteria

Exclusion criteria: The subjects are not allowed to participate in this study if they meet any of the following criteria: 1. Patients who have suffered from the severe diseases in respiratory system (such as tuberculosis, etc.), endocrine, nervous system, cardiovascular system, digestive system or urogenital system; 2. Patients who have suffered from the contraindications or allergies of CsA; 3. Patients with smoking cigarettes more than the number of 20 for one day; 4. Patients with genital tract virus infection or cervical slack or genital malformations (such as double uterus, etc.), endocrine abnormalities (such as diabetes, etc.) or chromosomal abnormalities; 5. Patients with the history of miscarriage caused by embryo chromosomal abnormalities two or more times; 6. Unwilling to sign informed consent or follow the doctor's order; 7. HBV, HCV, HIV, HPV or infectious diseases such as syphilis, influenza, gonorrhea, etc.; 8. Patients with severe endometrial disease such as atypical hyperplasia; 9. BMI > 30; 10. Patients who were diagnosed as autoimmune diseases (including but not limited to rheumatoid arthritis, systemic lupus erythematosus, Inflammatory myopathy, systemic sclerosis, Sjgren's syndrome, antiphospholipid syndrome, etc.); 11. Patients who have became pregnant successfully by embryo transfer or showed fetal heart or germ in B-ultrasound; 12. Patients who have a history of thrombosis or have been cured; 13. Patients with mental illness or other reasons that can't cooperate with treatment; 14. Patients with heart, liver, kidney and other important organ diseases seriously or tumors or cancer; 15. The investigator judges that the patient's condition is not suitable for the research.

Design outcomes

Primary

MeasureTime frame
live birth rate;

Secondary

MeasureTime frame
Serum markers;The rate of successful pregnancy more than 3 months;Neonatal and infant evaluation;Immune indexes;

Countries

China

Contacts

Public ContactDajin Li

Obstetrics & Gynecology Hospital of Fudan University

djli@shmu.edu.cn+86 13916215487

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026