Analysis of the endometrial transcriptome at the time of implantation in women receiving a single post-ovulatory dose of levonorgestrel or mifepristone

Abstract Background: Levonorgestrel (LNG) is a progesterone receptor agonist used in both regular and emergency hormonal contraception; however, its effects on the endometrium as a contraceptive remain widely unknown and under public debate. Objective: To analyze the effects of LNG or mifepristone (MFP), a progesterone receptor antagonist and also known as RU-486, administered at the time of follicle rupture (FR) on endometrial transcriptome during the receptive period of the menstrual cycle. Methods: Ten volunteers ovulatory women were studied during two menstrual cycles, a control cycle and a consecutively treated cycle; in this last case, women were randomly allocated to two groups of 5 women each, receiving one dose of LNG (1.5 mg) or MFP (50 mg) the day of the FR by ultrasound. Endometrial biopsies were taken 6 days after drug administration and prepared for microarray analysis. Results: Genomic functional analysis in the LNG-treated group showed as activated the bio-functions embryo implantation and decidualization, while these bio-functions in the T-MFP group were predicted as inhibited. Conclusions: The administration of LNG as a hormonal emergency contraceptive resulted in an endometrial gene expression profile associated with receptivity. These results agree on the concept that LNG does not affect endometrial receptivity and/or embryo implantation when used as an emergency contraceptive.

Sexualidad en el contexto de los procesos de vida de mujeres y varones con endocrinopatías: una aproximación cualitativa / Sexuality in the life processes context of women and men with endocrinopathies: A qualitative approach

Resumen Antecedentes las enfermedades del sistema endocrino pueden afectar la sexualidad por sus efectos hormonales, las comorbilidades asociadas y su impacto psicosocial, tema poco estudiado desde las perspectivas de personas con estas enfermedades. Objetivos: se realizó un estudio cualitativo dirigido a comprender las experiencias sexuales de mujeres y varones con enfermedades endocrinas que producen cambios en la apariencia física. Método: se estructuró un diseño de estudio analítico-interpretativo. Participaron 68 personas entre 20 y 45 años de edad, atendidos en el Instituto Nacional de Endocrinología, La Habana, Cuba. Los instrumentos de recolección de la información utilizados fueron una planilla de datos generales, una guía de entrevista en profundidad y dos pruebas psicológicas proyectivas. Los aspectos éticos fueron considerados. Resultados: de las entrevistas en profundidad, emergieron 4 temas: 1) la expresión multidimensional de la enfermedad, 2) enfermedad y áreas de vida, 3) ejercicio de la sexualidad con la enfermedad, y 4) estrategias de afrontamiento en el área sexual; vinculados con los significados expresados sobre la salud, el cuerpo, el género y la sexualidad. Conclusiones: las/los participantes contextualizaron sus experiencias sexuales en el impacto biopsicosocial de la enfermedad. La reproducción o cuestionamiento de los significados expresados influyó en la calidad de sus experiencias sexuales. El estudio mostró que esta constituye un área de vulnerabilidad para la salud integral de las/los participantes.

Abstract Background endocrine disorders may affect sexuality due to hormonal changes, associated comorbidities and psychosocial impact. This topic remains poorly researched from the perspective of people with these conditions. Objectives: a qualitative research was conducted to understand the sexual experiences of women and men living with endocrine disorders that change their physical appearance. Methods: an analytical-interpretive study was carried out with a sample of 68 participants aged between 20 and 45, and treated at the National Institute of Endocrinology, Havana, Cuba. Data collection instruments were a personal information sheet, an in-depth interview guide and two projective psychological tests. Ethical aspects were considered. Results: in-depth interviews gave rise to four topics: 1) multidimensional expression of the disease, 2) the disease and life areas, 3) sexuality with the disease, and 4) coping strategies in the sexual area. These topics were linked to the meanings of health, body, gender and sexuality. Conclusions: the participants contextualized their sexual experiences within the biopsychosocial impact of the endocrine disorder, as well as the reproduction or questioning of the meanings that influenced the quality of their sexual experiences. The study showed that sexuality is a vulnerable area for the participants' comprehensive health.

II. The research ethics involving vulnerable groups

Abstract Vulnerability in research occurs when the participant is incapable of protecting his or her interests and therefore, has an increased probability of being intentionally or unintentionally harmed. This manuscript aims to discuss the conditions that make a group vulnerable and the tools and requirements that can be used to reduce the ethical breaches when including them in research protocols. The vulnerability can be due either to an inability to understand and give informed consent or to unequal power relationships that hinder basic rights. Excluding subjects from research for the only reason of belonging to a vulnerable group is unethical and will bias the results of the investigation. To consider a subject or group as vulnerable depends on the context, and the investigator should evaluate each case individually.

I. The role of research ethics committees in observational studies: epidemiological registries, case reports, interviews, and retrospective studies

Abstract It is often unclear to the clinical investigator whether observational studies should be submitted to a research ethics committee (REC), mostly because, in general, no active or additional interventions are performed. Moreover, obtaining an informed consent under these circumstances may be challenging, either because these are very large epidemiological registries, or the subject may no longer be alive, is too ill to consent, or is impossible to contact after being discharged. Although observational studies do not involve interventions, they entail ethical concerns, including threats such as breaches in confidentiality and autonomy, and respect for basic rights of the research subjects according to the good clinical practices. In this context, in addition to their main function as evaluators from an ethical, methodological, and regulatory point of view, the RECs serve as mediators between the research subjects, looking after their basic rights, and the investigator or institution, safeguarding them from both legal and unethical perils that the investigation could engage, by ensuring that all procedures are performed following the international standards of care for research. The aim of this manuscript is to provide information on each type of study and its risks, along with actions to prevent such risks, and the function of RECs in each type of study.