Introduction to experimental design, data collection and data analyses for clinical biomedical research. Students will also examine ethical issues in biomedical science research using a case-study approach. Representative issues to be addressed may include data selection and retention, plagiarism, scientific review of grants and manuscripts, review of protocols by human studies committees (institutional review boards or IRB) and informed consent.

Applications-based statistical and analytical software is used to demonstrate Continuing Quality Improvement (CQI) adherence to Federal regulation, NCCLS/IFCC protocols, and other accrediting agency requirements. Special emphasis is on defining and controlling unstable error through a statistical modeling approach. Documentation structures for quality operations policy; and processes, procedures and implementation of a quality system are examined with special attention to assuring quality of point- of-care testing.

The course includes basic cell biology and principles of genetics; a review of the male reproductive system including hormonal control, early development, spermatogenesis and fertilization; a review of the female reproductive system including hormonal control, early development, oogenesis, the menstrual cycle, fertilization and early implantation.

The course will include a review of male physiology, spermatogenesis and fertilization. The procedures appropriate for evaluation of male fertility will be presented and conditions and diseases associated with male factor infertility will be discussed. Basic and advanced andrology tests and procedures for both diagnostic and treatment purposes will be reviewed. Micromanipulation procedures (intracytoplasmic injection ICSI ) and treatments using epididymal and testicular sperm will be introduced.

A review of basic immunology will be covered including an overview of the organs, tissues and cells that comprise the immune system, different forms of immunity and the basis of the immune response. The reproductive immunology segment will focus on antibodies associated with infertility and reproductive failure, and also will include properties of the immune system during pregnancy.

Student laboratories will focus on semen analysis, sperm function tests, and preparation of partner and donor semen for artificial insemination. Advanced andrology procedures, including the sperm penetration assay and the hemi-zona assay, will be discussed and protocols provided. Reproductive Immunology: Students will perform procedures for detecting anitisperm antibodies in semen and in serum. Sperm- cervical mucus testing and cross-testing will be performed using controlled donor semen and bovine cervical mucus.

Lecture: The course will include a review of the female reproductive system, fertilization and implantation. The procedures appropriate for evaluation of female fertility will be presented and conditions and diseases associated with female factor infertility will be discussed. Basic and advanced tests and procedures for the treatment of infertility will be presented with a focus on assisted reproductive technology procedures, including in vitro fertilization and related procedures, micromanipulation, embryo culture, and third party reproduction.

Principles of methods of cryopreservation will be covered and procedures for freezing human oocytes, embryos, and ovarian and testicular tissues will be detailed. Legal, ethical and policy issues associated with cryopreservation will be introduced. Laboratory sessions will focus on freezing human spermatozoa and mouse gametes and embryos.

Policy Current and anticipated regulation of assisted reproductive technology (ART) will be discussed. Laboratory management will be covered extensively and will include development of quality control and quality assurance programs for ART and andrology laboratories, Basic ethics principles will be introduced and ethical issues associated with the practice of ART will focus on controversial and research procedures, including embryonic stem cell research, human cloning, fetal reduction, nuclear and cytoplasmic transfer, embryo freezing and storage, gestational hosts and surrogacy.

Students must complete the checklist procedures while working under supervision. Andrology procedures will include semen analysis, sperm functions tests, microbiology, preparation of partner and donor semen for artificial insemination and cryopreservation of male gametes.