Use of Cyclosporin A for the Treatment of Recurrent Miscarriage

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Cyclosporine; Cyclosporins; Dydrogesterone

Criteria

Inclusion Criteria:

• Both the woman and her husband agree to participate and sign the informed consent form.

• Have a history of two or more unexplained recurrent miscarriages.

• Spontaneous conception.

• Gestational age less than 5 weeks.

• Have a normal menstrual cycle (>=23 and <=35 days) and biphasic pattern of basal body temperature before pregnancy.

• No significant chromosomal aberrations in the couple.

• Semen quality tests show not apparent abnormalities in husband

Exclusion Criteria:

• Age below 18 or above 41 years at conception.

• Present pregnancy is a result of donor insemination or egg donation.

• Significant uterine anomalies detected by ultrasonography, hysterosalpingography, or hysteroscopy.

• Contraindications of CsA (e.g. severe infectious diseases, tumor or immunodeficiency) or Dydrogesterone.

• Smoking more than 20 daily.