Active Clinical Trials

Epigenetics Study

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Studies on the Epigenetic Regulation of Human Pregnancy in  Fertile and Infertile Couples and Placental Parameters Sub-Study

 

What are the goals of the Epigenetic study?

Through obtaining samples of umbilical cord blood, umbilical cord cells and placenta cells, Doctors at the University of Pennsylvania Medical Center are performing a research study on factors impacting babies conceived through fertility treatments (Artificial Reproductive Technologies, or ART) in comparison to babies conceived without assistance. This study is hoping to answer for the first time whether fertility treatments have an effect on pregnancy and development. What is learned may modify our current fertility treatments, in order to optimize pregnancy outcomes.

Who is eligible to participate?

All healthy women who are going to deliver a baby are invited to participate in the Epigenetics Study, as long as they meet the eligibility criteria.
Additionally, if you are a woman undergoing in vitro fertilization (IVF), you may be eligible to participate in our Sub-Study, which is looks more carefully at the growth, function and blood supply of the placenta during your pregnancy. 

What does participation involve?

For the Epigenetics Study, we are asking to obtain your placenta (which normally would be discarded post-delivery). From the placenta, umbilical cord blood, umbilical cord cells, and placenta cells will be collected for laboratory studies. There are no health risks to you or your baby, since the samples will be collected after your baby’s umbilical cord has been cut. 
Should you be enrolled in the sub-study, you will have an additional research visit close to 12 weeks of gestation. During this visit, we will perform a 3D ultrasound and a blood draw for 2 tubes of blood. Your blood samples will be frozen and stored for later analysis. The same health risks are involved in this visit, as any visit related to your infertility treatment. 
Both studies will not interfere with you or your baby’s clinical health. You will be in the study from the day you consent until the day you deliver. If at any time you change your mind, you may withdraw. All samples collected will be coded with a number to ensure that your name, and your baby’s name, will not be revealed. With your consent, the data may be shared with third parties for further analysis.

What are the benefits?

There are no direct benefits to you for participation in these studies, but you may be improving the chances for future mothers to have successful ART pregnancies. The results of these studies will not be made known to you or your doctor or become a part of your or your baby’s medical record. However, anything learned during the course of this study may help modify our current procedures. 
Should you be involved in the sub-study, you can enjoy taking home an ultrasound picture of your baby, and your parking or local transit costs will be covered.


By joining, you may help the future of mothers and medicine.

 

Principal Investigators:
Dr. Christos Coutifaris, MD, PhD
Dr. Suneeta Senapati, MD

For more information contact:
215-430-3813
pfcpennepigeneticscoordinators@uphs.upenn.edu

This study is recruiting from the clinical population only.

 

 

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