DuraMed Study

Fertility Centers of Illinois, SC, along with several other large infertility practices in the country, is participating in a Phase III Clinical Trial of an investigational drug for progesterone supplementation.  For subjects who qualify and are accepted into the study, Fertility Centers of Illinois, SC can provide an IVF cycle for to up to 80 subjects at no cost.  Participants will be responsible for the cost of all IVF medications, as well as embryo freezing and storage. 

 

Subjects will be assigned to one of our two IVF centers.  Subjects will initially be seen at our River North Chicago office, subsequent IVF monitoring can be done at either our River North or Highland Park IVF centers.  After successful IVF stimulation and egg retrieval, subjects will be assigned to one of two progesterone treatment groups.  Subjects will be either assigned to a group that will take the FDA approved progesterone drug or to a group that will take the investigational drug.  As with all drug studies there are strict criteria established by the study sponsor for both inclusion end exclusion into the study.

 

Criteria for inclusion include:

  1. Pre-menopausal, aged 18-42 old at time of consent

  2. At least one cycle without hormone medication prior to screening

  3. Tubal, idiopathic, male factor, ovulatory dysfunction or endometriosis-linked infertility

  4. Semen analysis (frozen sperm, including donor sperm, may be used, as long as testing done at time of freezing meets standard criteria)

  5. Others as indicated by FDA-approved protocol

 

Criteria for exclusion include:

  1. Any contraindication to progesterone therapy

  2. BMI > 38 kg/m2

  3. Clinically significant gynecologic pathology (for example: submucosal fibroids, abnormal uterine cavity, or others)

  4. History of more than 1 failed fresh IVF cycle

  5. More than 2 consecutive clinical miscarriages (gestational sac observed)

  6. Others as indicated by FDA-approved protocol 

 

To read the press release about this study, please click here.

 

 

If you feel that you qualify for this study based on meeting the criteria above, please click here to fill out the Study Questionnaire.