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This document presents current approaches and concerns regarding over-the-counter hCG devices. It is based on: 1) current science; 2) clinical experience; 3) previous submissions by manufacturers to the Food and Drug Administration (FDA); 4) the FDA Modernization Act of 1997 (FDAMA); and 5) FDA regulations in the Code of Federal Regulations (CFR). As advances are made in science and technology, and as changes in implementation of legislation occur, these Review Criteria will be re-evaluated and revised as appropriate. So that the draft may be revised as necessary, please send comments as instructed in the Preface.

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To thoroughly review the uses of human chorionic gonadotropin (hCG) related to the process of reproduction and also assess new, non-traditional theories. Review of the international literature and research studies. hCG and its receptor, LH/CGR, are expressed in numerous sites of the reproductive tract, both in gonadal and extra-goanadal tissues, promoting oocyte maturation, fertilization, implantation and early embryo development. Moreover, hCG seems to have a potential role as an anti-rejection agent in solid organ transplantation. Future research needs to focus extensively on the functions of hCG and its receptor LH/CGR, in an effort to reveal known, as well as unknown clinical potentials.Keywords: hCG, LH/CGR, ovulation induction, oocyte maturation, endometrial synchrony, immunization

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