NCT02488434 - Clinical Trial References

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.

Citation(s)

Asghar W, Velasco V, Kingsley JL, Shoukat MS, Shafiee H, Anchan RM, Mutter GL, Tüzel E, Demirci U
Selection of functional human sperm with higher DNA integrity and fewer reactive oxygen species. Adv Healthc Mater. 2014 Oct;3(10):1671-9. doi: 10.1002/adhm.201400058. Epub 2014 Apr 17.
Collins JA, Crosignani PG
Unexplained infertility: a review of diagnosis, prognosis, treatment efficacy and management. Int J Gynaecol Obstet. 1992 Dec;39(4):267-75. Review.
Moghissi KS, Wallach EE
Unexplained infertility. Fertil Steril. 1983 Jan;39(1):5-21. Review.
Practice Committee of the American Society for Reproductive Medicine
Definitions of infertility and recurrent pregnancy loss. Fertil Steril. 2008 Jun;89(6):1603. doi: 10.1016/j.fertnstert.2008.03.002. Epub 2008 May 16.
Templeton AA, Penney GC
The incidence, characteristics, and prognosis of patients whose infertility is unexplained. Fertil Steril. 1982 Feb;37(2):175-82.
Zini A, Finelli A, Phang D, Jarvi K
Influence of semen processing technique on human sperm DNA integrity. Urology. 2000 Dec 20;56(6):1081-4.

The Effectiveness of Using Fertile Chip on Intracytoplasmic Sperm Injection Undergoing Ivf Programme in Unexplained Infertile Couples

Clinical trial NCT02488434 - References