NCT02706470

Use of Cyclosporin A for the Treatment of Recurrent Miscarriage

A Randomized, Controlled Trial of Cyclosporin A for Women With Unexplained Recurrent Miscarriage

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Cyclosporin A (CsA) - an immunosuppressant drug - in early pregnancy will reduce the risk of miscarriage in women who had a history of unexplained recurrent miscarriages, as compared with that treated with Dydrogesterone-an active comparator. The hypothesis is based on the evidence found in vitro and in vivo experiments that CsA can induce maternal-fetal tolerance so that it may reduce the risk of miscarriage.

Conditions

• Miscarriage, Recurrent

Interventions

Type	Name	Description
DRUG	Cyclosporin A	Patients will receive oral CsA in a dose of 50mg three times a day for 20-30 days since the occurrence of positive result in human chorionic gonadotropin (HCG) test in urine and 14 consecutive days of elevated basal body temperature. The dosage of CsA will be adjusted according to baseline and peak value of CsA blood concentration. If the baseline blood concentration of CsA is lower than 40ng/ml or the peak blood concentration of CsA is lower than 500ng/ml, the dosage of CsA will be increased to 75 mg three times a day.
DRUG	Dydrogesterone	Patients will receive oral dydrogesterone 10 mg three times a day for 30 days since the occurrence of positive result in HCG test in urine and 14 consecutive days of elevated basal body temperature.

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-02-01
• Completion: 2018-12-01
• First posted: 2016-03-11
• Last updated: 2016-03-15

Locations

1 site across 1 country: China