Clinical Trial: Use of Cyclosporin A for the Treatment of Recurrent Miscarriage

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Fudan University

Current Primary Outcome: Live birth rate [ Time Frame: Up to 36 months ]

The difference in the live birth rates between patients with recurrent miscarriage assigned oral CsA and Dydrogesterone.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The difference in the rate of miscarriage between patients with recurrent miscarriage treated with CsA and Dydrogesterone. [ Time Frame: Up to 36 months ]
    The difference in the rates of miscarriage (pregnancy loss before 20 weeks gestation) between patients assigned oral CsA and Dydrogesterone.
  • Fetal death [ Time Frame: Up to 36 months ]
    The difference in the rates of fetal death (fetal death after 20 weeks of gestational age) between patients assigned oral CsA and Dydrogesterone.
  • The difference in the rate of premature delivery between patients treated with CsA and Dydrogesterone. [ Time Frame: Up to 36 months ]
    The difference in the rates of premature delivery (deliveries with gestational age less than 37 weeks) between patients assigned oral CsA and Dydrogesterone.
  • Congenital malformations [ Time Frame: Up to 36 months ]
    The difference in the rates of congenital malformations between patients assigned oral CsA and Dydrogesterone.
  • Maternal outcomes: morbidity of infectious disease [ Time Frame: Up to 36 months ]
    The difference of morbidity of infectious disease in pregnancy between two arms.


Original Secondary Outcome: Same as current

Information By: Fudan University

Dates:
Date Received: February 2, 2016
Date Started: May 2016
Date Completion: December 2018
Last Updated: March 12, 2016
Last Verified: March 2016