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

Anti-Müllerian hormone measurement for the diagnosis of polycystic ovary syndrome

Objective: Anti-Müllerian hormone (AMH) is derived from the small antral follicles, and an elevated level has been suggested to add value to the Rotterdam criteria for the diagnosis of PCOS in cases of diagnostic uncertainty. Therefore, the role of AMH in the classical phenotype of PCOS was defined within a Caucasian population. Design: This was a cross-sectional study. Patients: Sixty Five women without PCOS and 110 women with PCOS fulfilling all 3 diagnostic Rotterdam criteria. Measurements: The main outcomes were the utility of serum AMH for the diagnosis of PCOS and its relationship to the metabolic parameters. Results: Anti-Müllerian hormone was increased in PCOS compared to controls (P  < .001). Areas under the receiver operator curve showed AMH to be predictive of PCOS (0.76) using a cut-off AMH of 46 pmol/L, which is derived from the 95 th percentile of the controls that gave a 41% sensitivity and 86% specificity; an AMH cut-off of 35 pmol/L gave a 55% sensitivity and 79% specificity. Age- and BMI-adjusted multiple logistic regression showed that AMH was more predictive of PCOS independently of either serum testosterone (T) (OR = 4.04; 95% CI 1.42-11.11; P =.007) or free androgen index (FAI) (OR = 3.90; 95% CI 1.40-10.83; P =.009). Conclusion: Whilst an elevated AMH has poor sensitivity, it is fourfold more likely to be associated with a diagnosis of PCOS, and supplementary to biochemical parameters will make a positive diagnosis of PCOS in 22% of patients when neither serum testosterone nor FAI is elevated

Update on fertility preservation from the Barcelona International Society for Fertility Preservation–ESHRE–ASRM 2015 expert meeting: indications, results and future perspectives

STUDY QUESTION: What progress has been made in fertility preservation (FP) over the last decade? SUMMARY ANSWER: FP techniques have been widely adopted over the last decade and therefore the establishment of international registries on their short- and long-term outcomes is strongly recommended. WHAT IS KNOWN ALREADY: FP is a fundamental issue for both males and females whose future fertility may be compromised. Reproductive capacity may be seriously affected by age, different medical conditions and also by treatments, especially those with gonadal toxicity. There is general consensus on the need to provide counselling about currently available FP options to all individuals wishing to preserve their fertility. STUDY DESIGN, SIZE, DURATION: An international meeting with representatives from expert scientific societies involved in FP was held in Barcelona, Spain, in June 2015. PARTICIPANTS/MATERIALS, SETTING, METHODS: Twenty international FP experts belonging to the American Society of Reproductive Medicine, ESHRE and the International Society of Fertility Preservation reviewed the literature up to June 2015 to be discussed at the meeting, and approved the final manuscript. At the time this manuscript was being written, new evidence considered relevant for the debated topics was published, and was consequently included. MAIN RESULTS AND THE ROLE OF CHANCE: Several oncological and non-oncological diseases may affect current or future fertility, either caused by the disease itself or the gonadotoxic treatment, and need an adequate FP approach. Women wishing to postpone maternity and transgender individuals before starting hormone therapy or undergoing surgery to remove/alter their reproductive organs should also be counselled accordingly. Embryo and oocyte cryopreservation are first-line FP methods in post-pubertal women. Metaphase II oocyte cryopreservation (vitrification) is the preferred option. Cumulative evidence of restoration of ovarian function and spontaneous pregnancies after ART following orthotopic transplantation of cryopreserved ovarian tissue supports its future consideration as an open clinical application. Semen cryopreservation is the only established method for FP in men. Testicular tissue cryopreservation should be recommended in pre-pubertal boys even though fertility restoration strategies by autotransplantation of cryopreserved testicular tissue have not yet been tested for safe clinical use in humans. The establishment of international registries on the short- and long-term outcomes of FP techniques is strongly recommended. LIMITATIONS, REASONS FOR CAUTION: Given the lack of studies in large cohorts or with a randomized design, the level of evidence for most of the evidence reviewed was three or below. WIDER IMPLICATIONS OF THE FINDINGS: Further high quality studies are needed to study the long-term outcomes of FP techniques. STUDY FUNDING/COMPETING INTEREST(S): None. TRIAL REGISTRATION NUMBER: N/A

The Polycystic Ovary Syndrome Quality of Life scale (PCOSQOL): Development and preliminary validation

Polycystic ovary syndrome is an endocrine disorder amongst women, which can negatively impact quality of life. Research proposes that a more sensitive PCOS quality of life measure is needed. This study aims to develop and initially validate a quality of life scale for women with the condition in the United Kingdom. Women with PCOS (n = 714) took part in the development and initial validation of the 35-item polycystic ovary syndrome quality of life scale (PCOSQOL)(α = .95). Subscales include Impact of PCOS (α = .95), Infertility (α = .95), Hirsutism (α = .97) and Mood (α = .89). The PCOSQOL scale represents aspects of quality of life important to women with PCOS and may be more sensitive for use in the clinical and research settings

Couple's willingness to donate embryos for research: a longitudinal study

Introduction. Decision-making on embryo disposition is a source of distress and is subject to change over time. This paper analyses the willingness of couples undergoing in vitro fertilization to donate cryopreserved embryos for research from 15 days after embryo transfer to 12 months later, taking into account the influence of psychosocial, demographic, and reproductive factors. Materials and methods. Prospective longitudinal study, with 74 heterosexual couples undergoing in vitro fertilization in a public fertility centre in Portugal, recruited between 2011 and 2012. Participants were evaluated twice: 15 days after embryo transfer and 12 months later. Results. A significant decrease in patients’ willingness to donate embryos for research over time was observed [86.5% to 73.6%; relative risk (RR) = 0.85; 95% CI 0.76–0.95]. A higher education level (>12 years) [adjusted RR (RRadj) = 0.79; 95% CI 0.64–0.96], considering research on human embryos to be important (vs. very important) (RRadj = 0.59; 95% CI 0.39–0.85) and practicing a religion less than once a month (vs. at least once a month) (RRadj = 0.73; 95% CI 0.53–1.00) seemed associated with unwillingness to donate embryos for research over time. Change towards non-donation happened mainly among couples who first considered that it was better to donate than wasting the embryos. Change towards donation occurred mostly among those stating that their priority at time 1 was to have a baby and who became pregnant in the meantime. Conclusions. Quality of care guided by patients’ characteristics, values, preferences, and needs calls for considering the factors and reasons underlying couples’ willingness to donate embryos for research over time as a topic in psychosocial guidelines for infertility and medically assisted reproductive care.The authors thank Sandra Sousa for her collaboration in data collection. This study was funded by FEDER from the Operational Program Factors of Competitiveness – COMPETE and by national funding from the FCT – Foundation for Science and Technology (Portuguese Ministry of Education and Science) within the project “Health, governance and accountability in embryo research: couples’ decisions about the fates of embryos” (FCOMP-01-0124-FEDER014453), and the Grants SFRH/BD/75807/2011 (to CS) and SFRH/BPD/80530/2011 (to CF), co-funded by the POPH Program, the IF/00956/2013 (to SS) and the IF/ 00829/2013 (to HM)

‘Together … for only a moment’ British newspaper constructions of altruistic non-commercial surrogate motherhood

Objectives: To explore how national altruistic surrogacy is framed in a representative selection of the British press. Methods: A study of 90 British national newspaper articles was carried out using the Lexis-Nexis data base to search for articles on altruistic surrogacy. Content analysis of gain, loss, neutral frames and high or low alarm and vulnerability frames in the titles and the body of the text was carried out. The type of construction used in the article content was also analysed. Data were coded and consensus reached using a coding strategy specifically developed for the purposes of this study. Results: Titles and content were predominantly loss, high alarm and high vulnerability framed. The content was also gain framed, and written with a focus on the social and legal aspects differentially between the newspaper types. Discussion: The tabloid press emphasizes social issues, and the middle market and serious press focus on legal issues of altruistic surrogacy. Selectively framed and reinforced information provided by the different newspapers, reflect the different readership, with Tabloid readers likely to be, surrogates (mostly from lower socioeconomic strata) and serious/ middle-market readers likely to be commissioning parents (mostly professionals)