Use of Cyclosporin A for the Treatment of Recurrent Miscarriage

March 12, 2016 updated by: Jiangfeng Ye, Fudan University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

384

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200011
        • Obstetrics and Gynecology Hospital of Fudan University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
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.
Other Names:
  • Duphaston

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 36 months
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.
Up to 36 months
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.
Up to 36 months
Congenital malformations
Time Frame: Up to 36 months
The difference in the rates of congenital malformations between patients assigned oral CsA and Dydrogesterone.
Up to 36 months
Maternal outcomes: morbidity of infectious disease
Time Frame: Up to 36 months
The difference of morbidity of infectious disease in pregnancy between two arms.
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Dajin Li, MD, Obstetrics & Gynecology Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

February 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

February 2, 2016

First Submitted That Met QC Criteria

March 7, 2016

First Posted (Estimate)

March 11, 2016

Study Record Updates

Last Update Posted (Estimate)

March 15, 2016

Last Update Submitted That Met QC Criteria

March 12, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013SY034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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