Abstract:
:Since 2004, assisted conception is encompassed by the European Directive on the Quality and Safety of Tissues and Cells (2004/23/EC). The aim of a standard for quality and safety is to minimize risks of errors, contamination, and accidents and to maximize efficiency of use. This article presents a case study of the implementation of the Tissues and Cells Directive in the Leuven University Fertility Center (LUFC) with a focus on the assisted reproductive technologies laboratory with respect to laboratory facilities, quality management system, traceability, storage conditions as well as serological screening. Although the current European Union (EU) Directive can be considered a step in the right direction to improve patient safety, questions remain as to whether the implementation of this EU Directive, requiring extra time and money, has resulted in higher quality with respect to the quality dimensions of effectiveness, efficiency, timeliness, equity, and patient centeredness.
journal_name
Semin Reprod Medjournal_title
Seminars in reproductive medicineauthors
Willemen D,D'Hooghe T,Knoops I,De Neubourg D,Spiessens Cdoi
10.1055/s-0032-1311521subject
Has Abstractpub_date
2012-06-01 00:00:00pages
191-8issue
3eissn
1526-8004issn
1526-4564journal_volume
30pub_type
杂志文章abstract::Identifying appropriate candidates for menopausal hormone therapy (HT) is challenging given the complex profile of risks and benefits associated with treatment. Most professional societies agree that HT should not be used for chronic disease prevention. Recent findings from the Women's Health Initiative and other rand...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-0034-1384626
更新日期:2014-11-01 00:00:00
abstract::The medical treatment of endometriosis is a critical aspect of the therapeutic approach to this disease. Past methods have been based upon systemic hormonal alterations, resulting in suppression of this estrogen-responsive disorder. Treatments such as danazol, progestogens, oral contraceptives, GnRH-agonists, and gest...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-2003-41327
更新日期:2003-05-01 00:00:00
abstract::Randomized clinical trials (RCTs) have been used to assess interventions affecting health since biblical times. They provide the most valid means of measuring the true effects of intervention compared with no treatment or placebo. Although they can also be used to assess the value of diagnostic tests, this article foc...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-2003-39995
更新日期:2003-02-01 00:00:00
abstract::As sperm traverse the female tract from vagina to oocyte, they experience a steroid milieu, which due to transcriptional inactivity, they can only respond to via non-genomic signaling. This environment mediates events including capacitation, changes in motility patterns, chemotaxis, and acrosome reaction. Current know...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-2007-973433
更新日期:2007-05-01 00:00:00
abstract::Endocrine disrupters are exogenous substances that cause adverse effects in the endocrine system. Sexual differentiation is regulated by reproductive hormones. Male differentiation is critically dependent on normal androgen action, which in turn depends on normal production of luteinizing hormone. Other essential horm...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-2002-35377
更新日期:2002-08-01 00:00:00
abstract::The implementation of suitable quality control (QC) is not only required for the accreditation of a human in vitro fertilization (IVF) laboratory, but is also fundamental to its success. Several assays have been employed to screen culture media and contact supplies. The suitability of one assay in particular, the mous...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-2005-923389
更新日期:2005-11-01 00:00:00
abstract::Successful in utero stem cell transplantations with hematopoietic or other stem cells should represent a major step forward in the management of patients with congenital, hematological, metabolic, and immunological disorders. The possibility of performing cell transplantations with stem cells across histoincompatibili...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-2006-952156
更新日期:2006-11-01 00:00:00
abstract::Prior to the advent of modern minimally invasive surgery techniques, the primary surgical management of symptomatic leiomyomata for women desiring future fertility or uterine conservation was through laparotomy. Today, many cases of intramural and subserous leiomyomata are managed with laparoscopic myomectomy and sele...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-2004-828621
更新日期:2004-05-01 00:00:00
abstract::Whereas the importance of close monitoring and tight glycemic control in diabetic pregnancies cannot be ignored, the growing body of knowledge surrounding the different effects of diabetes mellitus on the earliest stages of reproduction underscores the need for aggressive screening among reproductive-aged women at ris...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-2008-1042957
更新日期:2008-03-01 00:00:00
abstract::The birth of a child with ambiguous genitalia is a challenging and distressing event for the family and physician and one with life-long consequences. Most disorders of sexual differentiation (DSD) associated with ambiguous genitalia are the result either of inappropriate virilization of girls or incomplete virilizati...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-0032-1324717
更新日期:2012-10-01 00:00:00
abstract::Pelvic pain, acute or chronic, accounts for more than 10% of referrals to gynecologists. Pain accounts for more than 40% of gynecologic diagnostic laparoscopies. Predicting operative findings is critical in planning surgical interventions, as well as preoperative and postoperative medical therapy. Ultrasound is useful...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-2008-1076144
更新日期:2008-05-01 00:00:00
abstract::Luteinizing hormone (LH) and human chorionic gonadotropin (hCG) share a common receptor in gonadal cells; however, the presence of these receptors has also been detected in several nongonadal but reproduction-associated tissues of pig, human, and other species. There are no data about the ontogeny of the human LH/hCG ...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-2001-13907
更新日期:2001-01-01 00:00:00
abstract::Follicular rupture and the transformation of an estrogenic preovulatory follicle into a highly vascularized corpus luteum capable of producing large quantities of progesterone are required for the establishment of pregnancy. These processes are dependent upon the precise remodeling of the ovarian extracellular matrix ...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-2006-948552
更新日期:2006-09-01 00:00:00
abstract::Old World monkeys display physiological responses to steroid hormones that are similar to those of women. In this review, we describe cyclic morphological changes that take place within the uterus of Old World primates during the menstrual cycle. In primates, estrogen stimulates endometrial growth in the follicular ph...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-0034-1376357
更新日期:2014-09-01 00:00:00
abstract::Endocrine-disrupting chemicals generally function as steroid receptor signaling antagonists or agonists that influence development to promote adult-onset disease. Exposure to the endocrine disruptors during the initiation of male reproductive tract development interferes with the normal hormonal signaling and formatio...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-0029-1237428
更新日期:2009-09-01 00:00:00
abstract::The maternal-fetal environment plays an important role in developmental programming of adult disease. Metabolic and hormonal dysfunction during human fetal development accompanies gestational diabetes as a common occurrence in mothers with polycystic ovary syndrome (PCOS), while human fetal androgen excess from congen...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-0034-1371087
更新日期:2014-05-01 00:00:00
abstract::Approximately 10 to 15% of the population experiences infertility. Although 85 to 90% of couples or individuals who experience infertility have a diagnosis for their infertility, underlying causes of infertility rarely are found. Extensive literature reporting adverse effects of environmental contaminants on wildlife ...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-2006-944418
更新日期:2006-07-01 00:00:00
abstract::Subclinical hypothyroidism has been found to be associated with adverse reproductive outcomes, such as infertility, miscarriage, preterm birth, and complications of pregnancy. Multiple studies have investigated the relationships between thyroid function, thyroid antibodies, fertility, and pregnancy. Thyroid autoimmuni...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-0036-1593487
更新日期:2016-11-01 00:00:00
abstract::In non industrialized countries the incidence of heavy menstrual bleeding (HMB) appears to be similar to that of industrialized countries, although data is scanty. In low-resource settings, women with abnormal uterine bleeding (AUB) often delay seeking medical care because of cultural beliefs that a heavy red menstrua...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-0031-1287668
更新日期:2011-09-01 00:00:00
abstract::The human uterus mainly consists of two layers: an inner endometrium and an outer layer, the myometrium, made of smooth muscle. The uterus is characterized by its unique capacity for regeneration. This capacity permits cyclical regeneration and remodeling of the tissue over the course of a woman's reproductive life. D...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-0032-1331801
更新日期:2013-01-01 00:00:00
abstract::Analysis of published series reveals that no more than a fourth of subfertile patients undergoing surgery for peritoneal endometriotic implants, rectovaginal endometriotic lesions, or recurrent endometriomas achieved conception spontaneously. First-line surgery for ovarian endometriotic cysts appears associated with a...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-0032-1333478
更新日期:2013-03-01 00:00:00
abstract::Intraperitoneal adhesions remain a costly, long-term sequela of abdominal surgery. They cause significant postoperative morbidity and difficult reoperative surgery. Although adhesions have been recognized for more than 250 years, a uniformly effective method of adhesion prevention does not exist. In recent years, rese...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-0028-1082391
更新日期:2008-07-01 00:00:00
abstract::Endometriosis is a common cause of infertility and disabling pelvic pain in reproductive age women. The most widely accepted theory of its pathogenesis is the retrograde flow of menstrual products, although extra-abdominal and extrapelvic diagnoses have been made. After the pelvic peritoneum and gynecologic structures...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-0036-1597124
更新日期:2017-01-01 00:00:00
abstract::Obesity-related infertility is one of the most common problems of reproductive-age obese women who desire childbearing. The various types of bariatric surgeries have proved effective in controlling excessive weight gain, improving fertility, and preventing certain maternal and fetal complications in these women. This ...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-0032-1328880
更新日期:2012-12-01 00:00:00
abstract::Despite the critical role the placenta plays in governing the outcome of pregnancy, a great deal remains to be learned about this transient organ. Several factors have contributed to our relative lack of knowledge. For example, most of the placenta's development, which precedes that of the embryo or fetus, occurs duri...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-2000-12569
更新日期:2000-01-01 00:00:00
abstract::Obesity is a pandemic and is associated with multiple medical problems including subfertility. Male obesity has been associated with altered semen parameters and reproductive hormonal levels, including a reduced testosterone:estradiol (T:E₂) ratio. Treatment methods employed for obesity-related male subfertility inclu...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-0033-1345272
更新日期:2013-07-01 00:00:00
abstract::Controlled ovarian stimulation (COS) is widely used in assisted reproduction techniques (ART). However, hormonal treatment induces endometrial alterations that may alter implantation rates compared with natural cycles. Endometrial alterations have been observed by histological and biochemical techniques. The recent de...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-2007-991043
更新日期:2007-11-01 00:00:00
abstract::Women with polycystic ovary syndrome (PCOS) most often seek treatment for reduction of hair growth and/or acne, restoration of menstrual cyclicity, and infertility. In addition, these patients are increasingly seeking advise and treatment for the metabolic abnormalities related to PCOS (e.g., insulin resistance and ty...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-2003-43305
更新日期:2003-08-01 00:00:00
abstract::Androgen receptors are present in numerous tissues throughout the female body, and knowledge of the specific actions of androgens at different sites is increasing, along with the understanding of their contribution to various pathophysiological states. This article reviews the physiology of androgens (testosterone and...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-2006-939565
更新日期:2006-04-01 00:00:00
abstract::The reproductive organs in both males and females consist of gonads, internal ductal structures, and external genitalia. Normal sexual differentiation is dependent on the genetic sex determined by the presence or absence of the Y chromosome at fertilization. Testes develop under the influence of the Y chromosome and o...
journal_title:Seminars in reproductive medicine
pub_type: 杂志文章,评审
doi:10.1055/s-2004-815593
更新日期:2003-11-01 00:00:00