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Segment I Study

We offer Fertility and Early Embryonic Development to Implantation (“Segment 1”) in rodents to determine the toxic effects/disturbances resulting from treatment with test articles before mating (males/females), through mating and implantation.

For females, this will detect effects on minimum of two complete oestrous cycles, tubal transport, implantation, and development of pre-implantation stages of the embryo. For males, it will permit detection of functional effects (e.g., on libido and sperm parameters) that may not be detected by histological examinations of the male reproductive organs.

Segment 1 study

This study is also intended to provide an estimate of the No Observed Adverse Effect Level (NOAEL) for fertility and reproductive toxic effects after a defined period of test item exposure i.e., from premating to conception and from conception to implantation.

Briefly, animals will be administered with the vehicle or test item formulations once daily for two to four weeks prior to cohabitation and during cohabitation. After completion of the cohabitation, males will be treated for an additional 14 days and females will be treated through the end of implantation i.e., gestation Day 7.

Endpoints in the study consisted of mortality checks (twice daily), clinical signs observations (twice daily during treatment days and once daily during non-treatment days), body weight and food consumption (twice weekly), determination of oestrous cycle length (during pre-treatment and treatment periods), precoital interval, mating, fertility and fecundity indices, sperm analysis (motility, count and morphology), total number of corpus lutea, total number of implantations, implantation index, pre and post implantation losses, total number of live and dead foetuses and proportion of live and dead foetuses, organ weights, gross pathology, and histopathology of a comprehensive list of organs/tissues from the vehicle control and high dose groups.

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