Skip to Main Content

Clinical Studies and Protocols

Site Map Investigators Log-in
(ZWI-0800) Pregnancy Tolerance

Download "IRB Approved Flyer" here
 Return to List of Clinical Studies
 Return to List of Protocols for Other
Maternal Tolerance of Pregnancy

Principal Investigator:
Zev Williams


Contact Information:
Recruitment Specialist
1230 York Avenue
New York, NY 10065
Telephone: 18007822737
Enrollment Status:

Brief Summary of Protocol:
The reason for doing this research is: to determine whether some women with recurrent and unexplained miscarriage have a change in their immune system that causes miscarriage due to improper function of their pTreg cells.

Detailed Description of Protocol:
Healthy women who have fully functioning immune systems are able to carry a pregnancy to term without their body rejecting it. Unfortunately, this is not the case for all women. One in five pregnancies do not progress beyond the first trimester and result in miscarriage. Some couples attempting to conceive experience recurrent miscarriage, defined as two or more consecutive miscarriages. In most cases, no cause is found. For many years, it has been believed that a cause of recurrent miscarriage was due to the mother’s “overly vigilant” immune system that mistakenly recognizes the fetus as “foreign” and rejects it from their body. Since the mechanism by which the mother’s immune system normally allows the pregnancy to continue was unknown, it had not been possible to determine if there was a problem in this pathway among women with recurrent miscarriage. Recent research in mice indicates that a specialized cell, called pTreg, allows the mother’s immune system to tolerate pregnancy and protects the fetus from rejection. In mice that did not have the pTreg cell, there was a higher rate of miscarriage.

What specifically makes a person eligible for the study?
You may be eligible to enter this study:

1. Must be between the ages 18-38 2. If post-miscarriage and must have at least two normal menstrual cycles and a negative b-Hcg. 3. Must have at least 4 miscarriages that have occured at less than 24 weeks gestation with no defined etiology and who have had a complete miscarriage evaluation. Ratio of miscarriages to live births should be 4:1 or greater. 4. Self-reported normal menstrual cycle (q 26 - 32 days) 5. No fertility treatment within one month of study entry (includes IVIG; paternal leukocyte transfusion; intralipid injection). 6. Cannot be currently pregnant 7. No liver disease, kidney disease, HIV, or cancer history 8. No tobacco use within the last year



Children permitted to participate:

Potential Benefits.....
No direct benefit

Compensation is provided