Infertility — Prospective, Randomized Trial Comparing ICSI to Insemination for Non-Male Factor Patients Undergoing PGT-A
Citation(s)
Deng J, Kuyoro O, Zhao Q, Behr B, Lathi RB Comparison of aneuploidy rates between conventional in vitro fertilization and intracytoplasmic sperm injection in in vitro fertilization-intracytoplasmic sperm injection split insemination cycles. F S Rep. 2020 Jul 27;1(3):277-281. doi: 10.1016/j.xfre.2020.07.006. eCollection 2020 Dec.
Niu X, Long J, Gong F, Wang W Does ICSI for in vitro fertilization cause more aneuploid embryos? Mol Cytogenet. 2020 Jul 1;13:27. doi: 10.1186/s13039-020-00497-z. eCollection 2020.
Palmerola KL, Vitez SF, Amrane S, Fischer CP, Forman EJ Minimizing mosaicism: assessing the impact of fertilization method on rate of mosaicism after next-generation sequencing (NGS) preimplantation genetic testing for aneuploidy (PGT-A). J Assist Reprod Genet. 2019 Jan;36(1):153-157. doi: 10.1007/s10815-018-1347-6. Epub 2018 Oct 25.
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.
