UNC Fertility is proud to offer individuals and couples the opportunity to participate in our ongoing clinical trials. Clinical trials change often so please check in frequently to see if there a study you be eligible for.
Current trials: FIT-PLESE
**We are no longer enrolling new patients for this study.**
What is FIT-PLESE?
FIT-PLESE is a research study on the effects of lifestyle modifications in obese women with unexplained infertility. The purpose of the study is to determine if lifestyle modification to lower weight and increase exercise improves fertility and reduces pregnancy complications.
What Will I Have to Do?
Participation in FIT-PLESE consists of two phases. In the first phase of the study, participants will do one of two lifestyle changes over 16 weeks. One group will increase their physical activity and track their physical activity using a Fitbit fitness watch. The other group will adhere to a calorie restricted diet using Nutrisystem meal replacements and a weight loss medication called Orlistat (Alli) while increasing physical activity. Both groups will receive prenatal vitamins. In the second phase of the study, couples receive fertility medication (Clomid) and insemination (IUI).
Male and female partners will have a screening visit. Women will provide blood and urine samples and undergo a physical exam. Women will have follow-up study visits during phase one. Study visits will be conducted at UNC Fertility in Raleigh and at UNC Hospitals in Chapel Hill. During phase two of the study, couples will receive up to 3 Clomid/IUI treatment cycles at UNC Fertility.
Who Can Join?
- Heterosexual couples, who have experienced infertility for a year or more
- Female partner must have
- Obesity as determined by a body mass index (BMI) >30 kg/m2
- Regular menstrual cycles
- Between 18 and 40 years of age
Women are not eligible if they:
- Have diabetes
- Are currently enrolled in a lifestyle program (Weight Watcher, Atkins diet, Curves)
- Have undergone bariatric surgery
- Have had a sterilization procedure
- Improve overall health and potentially lose weight
- Receive up to 3 cycles of infertility treatment (Clomid/IUI)
- Free pregnancy test and prenatal vitamins
- All participants receive a Fitbit and Aria scale during the study
- Alli (weight loss supplement) and Nutrisystem meals provided by the study