Free IVF Cycle Possible for Qualified Couples through DuraMed Clinical TrialTuesday, March 11, 2008 6:22
**NOTE: This article was written for informational purposes only. I am not personally affiliated with DuraMed, and have NO control over enrollment in this trial.**
Qualified women may be able to escape much of the cost associated with in vitro fertilization by participating in a clinical trial of a new progesterone supplement sponsored by DuraMed. The study is a phase III clinical trial, which will compare the effectiveness of a new vaginal ring progesterone preparation to a gel form of progesterone that is currently on the market. The primary outcome in this study will be the pregnancy rate at 8-12 weeks gestation, and secondary outcomes will include other measures like miscarriage rate and live birth rate.
Not all women will qualify for this study. FDA requirements for participants include:
- Pre-menopausal, aged 18-42 old at time of consent
- At least one cycle without fertility medication prior to screening
- Tubal, idiopathic, male factor, ovulatory dysfunction or endometriosis- linked infertility
- Semen analysis (frozen sperm, including donor sperm, may be used, as long as testing done at time of freezing meets standard criteria)
Automatic exclusion criteria include:
- Any contraindication to progesterone therapy
- BMI > 38
- Clinically significant gynecologic pathology (ie submucosal fibroids, abnormal uterine cavity, etc)
- History of more than 1 failed fresh IVF cycle
- More than 2 consecutive clinical miscarriages (gestational sac observed on ultrasound)
If you think you meet these criteria, and are interested in participating in the study or obtaining more information, you can contact one of the fertility clinics currently recruiting patients for the study. Study sites are currently located in 13 states, including Fertility Centers of Illinois. If you participate in this study, you may still be responsible for costs of non-study medication and embryo freezing, should you choose to use this service.
It’s important to note that phase I and II clinical trials have already been performed to examine the safety of this progesterone preparation, but like all research, there are still unknowns. You’ll need to weigh the potential benefits and risks of participating in this study on your own and with your doctor before agreeing to take part.