Family Health, Men's Health, Women's Health Seth Stratton | 11 months ago

Infertility Trial Focused on Men’s Antioxidant Intake Helps Couple Conceive

After eight years of trying to conceive on their own, a couple got pregnant within three months of enrolling in an infertility trial at Carolinas HealthCare System’s CMC Women’s Institute. CMC Women’s Institute is one of eight sites across the country who participated in the MOXI Trial, and was the only place in Charlotte to offer couples this opportunity.

Update: Last Year, the Wygals Welcomed Their First Child – A Healthy Baby Boy

(Updated February 2017) After spending eight years trying to conceive on their own, the Wygals turned to help from Carolinas Medical Center Women's Institute and an infertility drug called MOXI. They were pregnant within three months, and last year, they welcomed their first child a healthy baby boy.

The MOXI trial is no longer enrolling new couples, but there's good news: A second trial, FIT-PLESE, is now open for enrollment. FIT-PLESE is a weight loss trial that covers up to three IUI, or artificial insemination, cycles for qualified couples. To qualify, couples must have unexplained infertility when a woman's BMI is greater than 30. Please contact Kathy Ramsey at 704-355-2949 or Deanna Hamm at 704-355-7261 for more information.



Tasha Wygal, a cosmetologist, and Caleb Wygal, an author and entrepreneur, got married in 2002. “It was literally love at first sight,” says Caleb. “When I saw her I said to myself, ‘that's the girl I'm going to marry.’ I didn't quite get her number that night, but I did the next week, and eight months later we were married.”

The Wygals originally started thinking about starting a family in 2009 after they found out Caleb's younger brother and his wife were expecting their first child. They had hoped to have children who would be close in age.

When traditional conception methods didn’t work, they decided to seek out a fertility expert’s opinion. The couple was referred to Rebecca S. Usadi, MD, an associate director of reproductive endocrinology at CMC Women’s Institute. After the initial consultation, Dr. Usadi explained that the couple fell into the category of unexplained infertility and thought they might be a good fit for a clinical trial called MOXI (Males, Antioxidants and Infertility).

Infertility Trial Proves Fruitful

MOXI is a double-blind, placebo-controlled trial that examines whether mildly infertile males who take a twice daily dose of antioxidants in pill form will experience a boost in fertility. In a double blind placebo trial, some of the participants are given the treatment, others are given fake treatment (placebo), and neither the researchers nor the participants know which is which until the study ends.

The hope of the trial is that the antioxidants will prove to improve sperm quality, resulting in higher fertilization rates and improved embryo development. 

The study is also looking to see if the antioxidants can improve the quality of the sperm, which would allow for couples with unexplained infertility to use less intensive therapies to get pregnant. Another upside of the MOXI trial is a cost savings on expensive infertility treatments. The trial covers the cost of three clomiphene (medication used to treat infertility) and intrauterine insemination (a fertility treatment) cycles for qualifying couples. 

“It sounded like a win-win, and our best chance at having a child,” says Caleb.

Just a few weeks into the trial, Tasha had a feeling she that she might be pregnant. Her period was few days late, and she had serious heartburn. 

“Seeing as how I may have been taking the real MOXI and not the placebo, I just hoped that it might have done the trick.”

Then, a visit with Dr. Usadi confirmed what they suspected – Tasha was indeed pregnant. The couple was ecstatic, apprehensive and nervous all at once. 

Caleb’s advice to other couples facing similar circumstances: “Hang in there and keep trying! Yes, it can be discouraging, but try to look at the positives throughout the process. It took nearly eight years for us, but with the right team of people, you can do it, too.”


More About MOXI

The MOXI trial is now closed for enrollment. CMC Women’s Institute was one of eight sites across the country participating in the MOXI trial, and was the only place in Charlotte to offer couples this opportunity. The trial was led by the Reproductive Medicine Network through the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NIH). The MOXI Trial was open to certain couples with unexplained infertility. Qualifying women were between 18 and 35 years old, have regular menstrual cycles and open fallopian tubes. Qualifying couples also needed to have mildly decreased sperm parameters. 

“Mild male factor infertility is so common. If this trial is successful, there may be a very simple, inexpensive intervention that can help couples conceive naturally,” said Dr. Usadi.

Shortly after the Wygals discovered their pregnancy, a second couple enrolled in the trial confirmed that they are pregnant. 


Couple becomes pregnant after enrolling in MOXI trial at Carolinas HealthCare System.
The Wygals (Caleb and Tasha, second from right) with (from left) Kathleen Bratschi, a clinical nurse,
Kathy Ramsey, MOXI study coordinator, and Dr. Rebecca Usadi, all with the Carolinas Medical Center Women's Institute.