Assisted reproductive technology in the USA: is more regulation needed?

The regulation of assisted reproductive technologies is a contested area. Some jurisdictions, such as the UK and a number of Australian states, have comprehensive regulation of most aspects of assisted reproductive technologies; others, such as the USA, have taken a more piecemeal approach and rely on professional guidelines and the general regulation of medical practice to govern this area. It will be argued that such a laissez-faire approach is inadequate for regulating the complex area of assisted reproductive technologies. Two key examples, reducing multiple births and registers of donors and offspring, will be considered to illustrate the effects of the regulatory structure of assisted reproductive technologies in the USA on practice. It will be concluded that the regulatory structure in the USA fails to provide an adequate mechanism for ensuring the ethical and safe conduct of ART services, and that more comprehensive regulation is required

The diagnosis of male infertility:an analysis of the evidence to support the developments of global WHO guidance. Challenges and future research opportunities

Background: Herein, we describe the consensus guideline methodology, summarize the evidence-based recommendations we provided to the World Health Organization (WHO) for their consideration in the development of global guidance and present a narrative review of the diagnosis of male infertility as related to the eight prioritized (problem or population (P), intervention (I), comparison (C) and outcome(s) (O) (PICO)) questions. Additionally, we discuss the challenges and research gaps identified during the synthesis of this evidence.Objective and Rationale: The aim of this paper is to present an evidence-based approach for the diagnosis of male infertility as related to the eight prioritized PICO questions.Search Methods: Collating the evidence to support providing recommendations involved a collaborative process as developed by WHO, namely: identification of priority questions and critical outcomes; retrieval of up-to-date evidence and existing guidelines; assessment and synthesis of the evidence; and the formulation of draft recommendations to be used for reaching consensus with a wide range of global stakeholders. For each draft recommendation the quality of the supporting evidence was then graded and assessed for consideration during a WHO consensus.Outcomes: Evidence was synthesized and recommendations were drafted to address the diagnosis of male infertility specifically encompassing the following: What is the prevalence of male infertility and what proportion of infertility is attributable to the male? Is it necessary for all infertile men to undergo a thorough evaluation? What is the clinical (ART/non ART) value of traditional semen parameters? What key male lifestyle factors impact on fertility (focusing on obesity, heat and tobacco smoking)? Do supplementary oral antioxidants or herbal therapies significantly influence fertility outcomes for infertile men? What are the evidence-based criteria for genetic screening of infertile men? How does a history of neoplasia and related treatments in the male impact on (his and his partner’s) reproductive health and fertility options? And lastly, what is the impact of varicocele on male fertility and does correction of varicocele improve semen parameters and/or fertility?Wider Implications: This evidence synthesis analysis has been conducted in a manner to be considered for global applicability for the diagnosis of male infertility

The Human Oocyte Preservation Experience (HOPE) a phase IV, prospective, multicenter, observational oocyte cryopreservation registry

<p>Abstract</p> <p>Background</p> <p>It has been recommended by the American Society of Clinical Oncology and the American Society of Reproductive Medicine that options to preserve fertility be presented at the outset of treatment for cancer. This recommendation may have arisen, in part, to the increasing survival of patients with cancer and the realization that certain forms of cancer treatment can lead to infertility. One option for these patients, particularly those with ethical or religious objections to freezing embryos is oocyte cryopreservation. However universal acceptance of these procedures has yet to be established, most likely due to a poor history of success and concerns that there has yet to be a comprehensive approach to evaluating these techniques. In light of this, a registry of patients undergoing oocyte cryopreservation, called the HOPE registry, is being implemented.</p> <p>Discussion</p> <p>The intent of the HOPE Registry is to enroll approximately 400 women of reproductive age who will undergo thawing/warming of oocytes and subsequent transfer. Data from the patients enrolled will be collected via a uniform, standardized form and will document important parameters such as demographics, laboratory procedures and outcomes, including following the outcomes of babies born for one year after birth. The results of the registry will be published on a yearly basis.</p> <p>Summary</p> <p>A patient registry has been established in order to systematically document the techniques and outcomes of oocyte cryopreservation procedures. The results will be published in order to provide a widely accessible resource that will allow patients who are considering these procedures validated information in order to make informed decisions as to how their treatment will proceed.</p

Preconception Care and Treatment with Assisted Reproductive Technologies

Couples with fertility problems seeking treatment with assisted reproductive technologies (ART) such as in vitro fertilization should receive preconception counseling on all factors that are provided when counseling patients without fertility problems. Additional counseling should address success rates and possible risks from ART therapies. Success rates from ART are improving, with the highest live birth rates averaging about 40% per cycle among women less than 35 years old. A woman’s age lowers the chance of achieving a live birth, as do smoking, obesity, and infertility diagnoses such as hydrosalpinx, uterine leiomyoma, or male factor infertility. Singletons conceived with ART may have lower birth weights. Animal studies suggest that genetic imprinting disorders may be induced by certain embryo culture conditions. The major risk from ovarian stimulation is multiple gestation. About one-third of live-birth deliveries from ART have more than one infant, and twins represent 85% of these multiple-birth children. There are more complications in multiple gestation pregnancies, infants are more likely to be born preterm and with other health problems, and families caring for multiples experience more stress. Transferring fewer embryos per cycle reduces the multiple birth rate from ART, but the patient may have to pay for additional cycles of ART because of a lower likelihood of pregnancy