Use of Cyclosporin A for the Treatment of Recurrent Miscarriage

Phase 2

• Conditions: Miscarriage, Recurrent
• Interventions: Drug: Cyclosporin A; Drug: Dydrogesterone

• Registration Number: NCT02706470
• Lead Sponsor: Fudan University

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 Description

Not available

Study Timeline

• Study First Submitted: 2016-02-02
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-07
• Study First Posted: 2016-03-11
• Last Update Submitted: 2016-03-12
• Last Update Posted: 2016-03-15
• Study Start: 2016-05
• Primary Completion: 2018-02
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 384

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cyclosporin A	Cyclosporin A	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.
Dydrogesterone	Dydrogesterone	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.

Primary Outcome Measures

Name	Time	Method
Live birth rate	Up to 36 months	The difference in the live birth rates between patients with recurrent miscarriage assigned oral CsA and Dydrogesterone.

Secondary Outcome Measures

Name	Time	Method
The difference in the rate of miscarriage between patients with recurrent miscarriage treated with CsA and Dydrogesterone.	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	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.	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	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	Up to 36 months	The difference of morbidity of infectious disease in pregnancy between two arms.

Trial Locations

Locations (1)

Obstetrics and Gynecology Hospital of Fudan University; 🇨🇳 Shanghai, China