Infertility — Lifestyle and Fertility Study on Antioxidant Status, Diet and Early Pregnancy
Citation(s)
Darche RL, Ruder EH, Blumberg J, Hartman TJ, Goldman MB Antioxidants in reproductive health and fertility. In Al-Gubory KH, Laher I (eds). Nutritional Antioxidant Therapies: Treatments and Perspectives. Springer-Verlag (Germany), in press.
Pacis MM, Goldman MB, Fung JL, Reindollar RH Is there an association between Vitamin D intake and time to conception? Data from the FASTT trial. American Society for Reproductive Medicine, Boston, MA, October 12-17, 2013.
Paine MA, Ruder EH, Hartman TJ, Blumberg J, Goldman MB Oxidative stress, oogenesis, and folliculogenesis. In: Studies on Women's Health. Oxidative Stress in Applied Basic Research and Clinical Practice. Agarwal A, Aziz N, Rizk B (eds.), Humana Press, 2013.
Patchell FS, Ruder EH, Mitchell DC, Hartman TJ, Goldman MB A comparison of energy and antioxidant intake using the Block FFQ and unannounced 24-hour recalls among couples planning pregnancy. 7th International Conference on Diet and Activity Methods, June
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.
