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: MOXI and FIT-PLESE

What is the MOXI Trial?

MOXI (Male, Antioxidants and Infertility Trial) is a research study of heterosexual couples who are experiencing infertility. The purpose of MOXI is to see if treatment of infertile males with a daily antioxidant combination, will help male fertility.

What Will I Have to Do?

Screening Visit: 

  • Male and female partners will come into the clinic to meet with the study team to determine eligibility. This may require additional testing.

Study Visits: 

  • If eligibility is determined for you and your partner, you will come to UNC Fertility for up to 4 study visits (for males) and up to 3 IUI (Intrauterine Insemination)/Clomid cycles. Male partners will be asked to provide semen samples throughout the study. Both partners will provide blood and urine samples.
  • Male partners will be given an antioxidant combination or placebo to take every day for up to six months. Neither you nor the study staff will know which treatment you will receive.
  • Following three months of male antioxidant therapy, couples will begin infertility treatments (Clomid/IUI) for up to 3 cycles.

Who Can Join?

Couples may be eligible to participate if they:

  • Have been trying to get pregnant for a year or more and the female partner is under 35 years of age or have been trying to get pregnant for 6 months or more and the female partner 35 years of age or older
  • Are heterosexual
  • Are living together and are able to have regular intercourse

Couples are not eligible to participate if:

  • The female partner has a body mass index of over 35 kg/m2
  • The female partner has a history of polycystic ovarian syndrome (PCOS)
  • Either partner has had any sterilization procedures (vasectomy, tubal ligation)
  • The female partner is over the age of 40

How Do I Join?

Call or email Raven Kidd, Study Coordinator

919-908-0000 ext. 213

raven_kidd@med.unc.edu

Benefits and Cost

  • Participants receive up to 6 months of antioxidant treatment
  • Participants may receive up to 3 cycles of infertility treatment (Clomid/IUI)
  • Free ovulation predictor kits and pregnancy tests
  • Satisfaction knowing you are contributing to our knowledge about infertility

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

How Do I Join?

Contact: Jaslyn Grullon, MPH

Study Coordinator

919-843-8246

jaslyn_grullon@med.unc.edu

Benefits

  • 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