Male Infertility — Impact of Sperm DNA Integrity on In Vitro Cycles
Citation(s)
Andreetta AM, Stockert JC, Barrera C A simple method to detect sperm chromatin abnormalities: cytochemical mechanism and possible value in predicting semen quality in assisted reproductive procedures. Int J Androl. 1995 Jun;18 Suppl 1:23-8.
Collins JA, Barnhart KT, Schlegel PN Do sperm DNA integrity tests predict pregnancy with in vitro fertilization? Fertil Steril. 2008 Apr;89(4):823-31. Epub 2007 Jul 20. Review.
Schlegel PN, Paduch DA Yet another test of sperm chromatin structure. Fertil Steril. 2005 Oct;84(4):854-9. Review.
Sharma RK, Said T, Agarwal A Sperm DNA damage and its clinical relevance in assessing reproductive outcome. Asian J Androl. 2004 Jun;6(2):139-48. Review.
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.
