The effectiveness, safety, and economic evaluation of Korean medicine for unexplained infertile women: A multi-center, prospective, observational study protocol.

Infertility is a condition in which a woman has not been pregnant despite having had normal intercourse for 1 year. The number of unexplained infertile females is increasing because of late marriage customs, as well as environmental and lifestyle habits. In Korea, infertile females have been treated with Korean medicine (KM). However, these effects have not been objectively confirmed through clinical trials. Therefore, this study was conducted to demonstrate the effectiveness of herbal medicine treatment in infertile patients and to demonstrate the economic feasibility through economical evaluation with assisted reproductive technology.This study is designed as a multicenter, single-arm clinical trial. All participants included will be from 3 Korean Medicine hospitals in Korea and will voluntarily sign an informed consent agreement. All recruited patients will conduct related surveys and tests, and be provided with treatment according to their menstrual cycle. Patients will take herbal medicines for 4 menstruation cycles and receive acupuncture and moxibustion treatment at 3 times (menstrual cycle day 3, 8, 14) during 4 menstruation cycles. They will also undergo an approximately 4 menstrual cycle treatment period, and 3 menstrual cycle observation period. If pregnant during the study, participants will take the herbal medicine for implantation for about 15 days. In this study, the primary outcome will be the clinical pregnancy rate, whereas the secondary outcome will include the implantation rate, ongoing pregnancy rate, and live birth rate.Ultimately, this study will provide clinical data regarding the effectiveness and safety of KM treatment for females with unexplained infertility and important evidence for establishing standard KM treatments for unexplained infertility. Moreover, we will identify the most cost-effective way to treat unexplained infertility. TRIAL REGISTRATION IDENTIFIER: Korean Clinical Trial Registry (CRIS), Republic of Korea: KCT0002235. Date: February 21, 2017 (retrospectively registered).

[Body, rights and comprehensive health: Analysis of the parliamentary debates on the Gender Identity and Assisted Fertilization Laws (Argentina, 2011-2013)]. / Cuerpo, derechos y salud integral: Análisis de los debates parlamentarios de las leyes de Identidad de Género y Fertilización Asistida (Argentina, 2011-2013).

In this paper we present an analysis of the parliamentary debates of the Gender Identity Law (No. 26743) and the Assisted Fertilization Law (No. 26862) carried out in the Argentine National Congress between 2011 and 2013. Using a qualitative content analysis technique, the stenographic records of the debates were analyzed to explore the following questions: How was the public problem to which each law responds characterized? How was the mission of each law conceptualized? To what extent did those definitions call into question ideas of health and illness, in including in the public health system coverage for certain medical treatments of body optimization or modification? In the process of sanctioning both laws, the concepts of health and disease were put into dispute as moral categories. In this context, an expanded concept of comprehensive health arose, in which desires regarding reproduction and the body were included.

Should there be a female age limit on public funding for assisted reproductive technology?

Should there be a female age limit on public funding for assisted reproductive technology (ART)? The question bears significant economic and sociopolitical implications and has been contentious in many countries. We conceptualise the question as one of justice in resource allocation, using three much-debated substantive principles of justice-the capacity to benefit, personal responsibility, and need-to structure and then explore a complex of arguments. Capacity-to-benefit arguments are not decisive: There are no clear cost-effectiveness grounds to restrict funding to those older women who still bear some capacity to benefit from ART. Personal responsibility arguments are challenged by structural determinants of delayed motherhood. Nor are need arguments decisive: They can speak either for or against a female age limit, depending on the conception of need used. We demonstrate how these principles can differ not only in content but also in the relative importance they are accorded by governments. Wide variation in ART public funding policy might be better understood in this light. We conclude with some inter-country comparison. New Zealand and Swedish policies are uncommonly transparent and thus demonstrate particularly well how the arguments we explore have been put into practice.

[Oocyte vitrification and its impact on the clinical practice of assisted reproduction]. / La vitrification des ovocytes et les changements induits dans nos pratiques d'AMP.

Oocyte vitrification is a new technique in cryobiology that will lead to a number of improvements in assisted reproduction practices, oocyte donation and the preservation of female fertility. Professionals already versed in the techniques of micromanipulation will be able to master the new procedures, which should not be delegated to unqualified staff. When adopted by clinical units, oocyte vitrification will require changes in laboratory and administrative organization. The technique will also modify the ethical outlines of reproductive biology. France today is running behind in the application of this major development in cryobiology. The reasons are many and have to do with a long waiting period for authorization from national health authorities, a lack of material and human resources and a foreseeable shake-up in the nationally established egg donation program. However, recently a new law of bioethics has recognized the breakthrough that this new technique represents by allowing couples covered by the French national health care program for Assisted Reproductive Technologies (ART) to choose oocyte vitrification as an option.

What counts and how to count it: physicians' constructions of evidence in a disinvestment context.

Internationally, there is an increasing focus on quality and sustainability measures oriented to reducing inefficiencies in health provision. The use of assisted reproductive technologies (ART) for older women represents a case study in this area. This paper analyses the constructions of evidence brought to bear by ART physicians in the context of deliberative stakeholder engagements (held 2010) around options for restricting public subsidy of ART in Australia. Physicians participated in two deliberative engagements during which they were presented with results of a systematic review of ART effectiveness, as well as ethical and cost analyses. These sessions were part of a broader research program of engagements held with policymakers, community members and consumers. Physicians deliberated around the data presented with a view to formulating an informed contribution to policy. The ensuing discussions were transcribed and subject to discourse analysis. Physicians questioned the evidence presented on the grounds of 'currency', 'proximity', 'selectivity' and 'bias'. We outline physicians' accounts of what should count as evidence informing ART policy, and how this evidence should be counted. These accounts reflect implicit decisions around both the inclusion of evidence (selection) and the status it is accorded (evaluation). Our analysis suggests that participatory policy processes do not represent the simple task of assessing the quality/effectiveness of a given technology against self-evident criteria. Rather, these processes involve the negotiation of different orders of evidence (empirical, contextual and anecdotal), indicating a need for higher-level discussion around 'what counts and how to count it' when making disinvestment decisions.

Fertility and cancer: psychological support in young women who contemplate emergency assisted reproductive technologies (ART) prior to chemo- and/or radiation-therapy.

PRINCIPLES: Women of reproductive age with cancer fear for their childbearing potential as a result of the cancer itself and chemo- and/or radiation-therapy. METHODS: Starting in 2006, a dedicated task force was set up at Lausanne University Hospital (CHUV) to handle all cancer and fertility issues and, in certain cases, offer access to emergency assisted reproductive technologies (ART) to preserve further childbearing options. Help provided by the task force was offered within a multidisciplinary framework encompassing psychological counselling offered to each patient or couple. RESULTS: We report here the salient points of the experience gained through dedicated psychological counselling offered to cancer patients concerned about their future fecundity. This was done with the intention of underscoring the most clinically relevant lessons learned through our experience at CHUV. CONCLUSIONS: The specific 'cancer and fertility' counselling instituted at CHUV offers support for young women or couples confronted with stressful cancer and fertility issues. This type of specific counselling, the resource counselling, appears to be a particularly appropriate tool for patients abruptly involved in difficult decision-making processes under time constraints and thus extremely vulnerable. The personal feedbacks from the patients also confirm the importance of offering specific counselling and timely psychological support of the type reported here to all women of reproductive age before starting chemo- and/or radiation-therapy.

Who should pay for assisted reproductive techniques? Answers from patients, professionals and the general public in Germany.

BACKGROUND: Financing ART is variously regulated in the different countries of Europe. In Germany, coverage of assisted reproduction by statutory health insurances was restricted to 50% in 2004. We conducted a national survey among patients, professionals (physicians and other academics in IVF centres, psychosocial counsellors, medical ethicists, social lawyers, health politicians) and the general public in Germany regarding their opinions on financing ART. METHODS: Standard questionnaire techniques (paper and pencil interviewing, computer-aided web interviewing, computer-aided telephone interviewing) were used. RESULTS: The vast majority of all groups supported public coverage of ART. Co-payments by patients were considered appropriate by about one-third of the patients, two-third of the physicians and three quarters of all other groups. According to the respondents, the amount of co-payment should cover 15-25% of the costs, considerably less than what patients actually have to pay (50%). Support for public coverage was strongly correlated with the views (i) of infertility as a disease, (ii) that there is a need for assisted reproduction for infertile couples and (iii) that every human should have the opportunity to have children. The respondents had varying opinions on whether to increase medical insurance premiums in order to cover ART. Reducing services in other areas of health care in favour of reproductive medicine was supported only by the group of reproductive physicians. Financial incentives for oocyte sharing were rejected by most groups as was a money-back guarantee for unsuccessful treatments. CONCLUSIONS: Experts and the general public in Germany accept moderate co-payments for ART. No clear pattern of opinion emerged regarding the question of how public co-funding should be financed.

[What is the validity limit of patient reimbursement? Is age a criterion for refusal? Yes....]. / Au-delà de quelle limite votre ticket n'est plus valable? L'âge est-il un critère de refus? Oui...

Selection is probably necessary for women undergoing ART (Assisted Reproductive Therapy), since cost of technique is very important. Furthermore, the right to try to achieve a pregnancy is a debatable issue, since the delivery rates are very low for ageing women. Success rates decrease strongly for women over 40, and women must be informed of it. Women 40 years or older are significantly less likely to achieve pregnancy with IUI as compared to women under age 35. The older women are also significantly less likely to achieve pregnancy with in vitro fertilization (IVF and IVF-ICSI). Costs per cycle were similar, however, for both groups. Moreover, older women utilizing assisted reproductive techniques are four to five times less likely to achieve normal delivery than the younger group, since pregnancy loss rate is greater. This poor prognosis for success in older women adds significantly to the mean cost per pregnancy as compared to younger women. Now, public institutions advocate and impose an age limit upon women who which to undergo ART. Ovulation induction should not be administrated for women over 45 years old (AFSSAPS, 2003). One should recommend not to propose to women over 42 years old and to men over 59 years old (Guidelines, 2004). Moreover, ART techniques cannot be reimbursed for women over 43 years old (CCAM, 2005).

[What is the validity limit of patient reimbursement? Is age a criterion for refusal? No...]. / Au-delà de quelle limite votre ticket n'est plus valable? L'âge est-il un critère de refus? Non...

The late 20th century trend to delay birth of the first child until the age at which female fecundity or reproductive capacity is lower has increased the incidence of age-related infertility. In the female, the number of oocytes decreases with age until the menopause. Oocyte quality also diminishes, due in part to increased aneuploidy. A significantly lower pregnancy rate per stimulation and delivery rate per retrieval is found in women aged 40 to 45 years when compared with women aged 25 to 39 years. However, acceptable pregnancy can be achieved in woman aged 40 to 43 years (4 to 8%). Furthermore, very few women aged over 40 ask for IVF procedure.

[Your ART ticket is no longer valid after how many attempts?]. / A partir de combien de tentatives votre ticket n'est plus valable?

The economic implications of the use of assisted reproductive techniques require consideration. Since March 2005, in France, only 6 intrauterine inseminations and 4 IVF attempts are free of charge for the patient. However, definition of "acceptable" pregnancy rate for a new attempt remains discussed (10%, 15%, 20%?). Furthermore, several criteria should be considered when discussing a new IVF attempt, including woman age, FSH levels, antral follicle count and infertility aetiology. For example, in patients with secondary infertility, reasonable pregnancy rates (15-20%) can be archived even after 6 or 7 failures.

What is the most relevant standard of success in assisted reproduction? Redefining success in the context of elective single embryo transfer: evidence, intuition and financial reality.

Treatment-related multiple pregnancy poses the biggest threat to the safety of IVF. Despite a double embryo transfer (DET) policy in most European centres, twin rates continue to be unacceptably high, at 20-35%. Elective single embryo transfer (SET) is an effective way to minimize twin pregnancies, but the debate surrounding its routine clinical use continues. A review of the literature was undertaken in order to seek evidence about the effectiveness of SET, and identify barriers to its acceptance in clinical practice. Data from randomized controlled trials (RCTs) indicate that SET results in lower live birth rates per fresh IVF cycle (odds ratio 0.53; 95% confidence interval 0.31-0.89; P = 0.02) in comparison with DET. Data on cumulative live birth rates are unavailable from RCTs, although the expectation is that these are comparable in the two groups. SET is unlikely to be suitable for all women undergoing IVF and outcomes may be sensitive to different laboratory protocols. The perceived effectiveness of SET is influenced by the way existing evidence is interpreted. Other factors affecting the routine use of SET include laboratory techniques, individual preferences and funding issues.