Use of Cyclosporin A for the Treatment of Recurrent Miscarriage

Fudan University

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Miscarriage, Recurrent

Treatments: Drug: Dydrogesterone; Drug: Cyclosporin A

Study type: Interventional

Funder types: Other

Identifiers

NCT02706470

2013SY034

Details and patient eligibility

About

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.

Enrollment: 384 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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384 participants in 2 patient groups

Cyclosporin A

Experimental group

Description:

Patients allocated to Cyclosporin A group will receive oral Cyclosporin A in a dose of 50 mg three times a day for 20-30 days in early pregnancy.

Treatment:

Drug: Cyclosporin A

Dydrogesterone

Active Comparator group

Description:

Patients allocated to dydrogesterone group will receive oral dydrogesterone in a dose of 10 mg three times a day for 30 days in early pregnancy.

Treatment:

Drug: Dydrogesterone