Male and Female Fertility Assessment in the Cynomolgus Monkey Following Administration of ABT‐874, a Human Anti‐IL‐12/23p40 Monoclonal Antibody

Abstract

These results demonstrate that ABT-874 had no adverse effects on reproductive hormones or fertility parameters in male or female cynomolgus monkeys.

Favorable modulation in neurotransmitters: Effects of chronic anterior thalamic nuclei stimulation observed in epileptic monkeys

“…In accord with similar studies, we determined that six animals per group was a sufficient number to reveal significant differences (Enright et al, 2012;Ragen et al, 2012;Yang et al, 2011). The experimenters were completely blinded to the group information in this study.…”

Toxicologic Pathology Forum*: Opinion on Sexual Maturity and Fertility Assessment in Long-tailed Macaques (Macaca fascicularis) in Nonclinical Safety Studies

“…Hence, for analysis of sperm motility and morphology—either manually or using automated systems—only the liquid portion (exudate) of ejaculated semen is available. End points for evaluation include semen volume, sperm count, sperm motility, and sperm morphology (Weinbauer et al 1988; Hurtt et al 1992; Enright et al 2012). Results from sperm analysis, however, show very high intra- and interindividual variability (Cappon et al 2013).…”

“…L. Fraser et al 2015). For studying the effects of interferons, animals were dosed for one complete cycle starting at the first day of menstrual bleeding (followed by two treatment-free cycle periods) and the study revealed a delayed mid-cycle hormone peak and prolonged cycle duration (Enright et al 2012). In the case of antigonadotropic factors, a 30-day study duration with a synchronized dosing start enabled detection of cycle disruption (unpublished data) and detection of related endocrine effects (H.…”

“…As mentioned before, frequent/regular blood sampling is needed and should follow one complete ovarian cycle before dosing as well as one or two ovarian cycles throughout dosing (and one in recovery, if applicable). Many studies include the collection of frequent blood samples, for example, on cycle days 1, 4, 7, 10, 11, 12, 13, 14, 15, 16, 18, 20, 24, and 27 (Enright et al 2012; Weinbauer et al 2008). Analysis of hormones is typically only included if vaginal swabs have indicated endocrine abnormalities.…”

“…A potential shortfall of penile stimulation to be mentioned is that some animals-unlike with rectal probe stimulation-do not respond to penile stimulation and will not provide an ejaculate. For each animal, semen collection should be conducted at least once before dosing with the test article and then every 4 to 8 weeks throughout the treatment period (Enright et al 2012). Macaque semen solidifies and the resulting coagulum is digested with a trypsin solution in order to release sperm for enumeration.…”