Abstract:
:In 2006 the Dutch Society for Clinical Embryologists (KLEM) approached the Netherlands Standardisation Institute (NEN) for advice regarding the lack of safety and quality specifications for medical devices used in assisted reproductive technology. A project plan was drafted in accordance with NEN-standardized methods for the development of norms and Dutch technical specifications (NTA) and a working group was launched consisting of all interested parties. A framework was then set up to develop an NTA that focused on the safety of gametes, embryos and the unborn offspring. The three main parts of the NTA describe the classification of medical devices, the requirements for new and existing devices and testing methods. The content of the NTA can be considered mainly as a consensus of the participants in the working group from both industry and clinical embryologists (KLEM). A final draft was sent to representatives from or allied to the government and to a notified body, and NTA 8070, entitled Devices for Assisted Reproductive Technologies (ART), was issued in March 2008.
journal_name
Reprod Biomed Onlinejournal_title
Reproductive biomedicine onlineauthors
Wetzels AM,Kastrop PM,NTA-Working Group.doi
10.1016/j.rbmo.2010.04.005subject
Has Abstractpub_date
2010-08-01 00:00:00pages
252-8issue
2eissn
1472-6483issn
1472-6491pii
S1472-6483(10)00182-3journal_volume
21pub_type
杂志文章abstract::Implantation requires highly orchestrated interactions between the developing embryo and maternal endometrium. The association between abnormal implantation and reproductive failure is evident, both in normal pregnancy and in assisted reproduction patients. Failure of implantation is the pregnancy rate-limiting step i...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章,评审
doi:10.1016/j.rbmo.2013.08.002
更新日期:2013-11-01 00:00:00
abstract::Anti-Müllerian hormone (AMH) has emerged as an important marker of ovarian reserve. Its variation throughout the cycle, however, may still be a matter of debate. The objective of this study was to re-evaluate the intra-cycle fluctuations of AMH in individuals in a prospective clinical study with focus on the age-relat...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/j.rbmo.2012.02.023
更新日期:2012-06-01 00:00:00
abstract:RESEARCH QUESTION:Previous studies of aromatase inhibitors on male infertility have focused on men with low testosterone-oestradiol ratio of less than 10. Can aromatase inhibitors improve spermatogenesis in men with idiopathic male infertility with normal testosterone-oestradiol ratio? DESIGN:Prospective study of men ...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/j.rbmo.2018.09.016
更新日期:2019-01-01 00:00:00
abstract::This worldwide web-based survey compared the clinical practice for luteal-phase supplementation (LPS) in stimulated IVF cycles to the current evidence-based literature. Eighty-four treatment centres in 35 countries, representing a total of 51,155 IVF cycles/year, responded. Vaginal progesterone alone was used for LPS ...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/j.rbmo.2012.04.005
更新日期:2012-08-01 00:00:00
abstract::The use of donor sperm is increasing, yet limited information is available about the health and development of children conceived from donor sperm. This retrospective descriptive study aimed to assess health and development in a cohort of school-aged children who were conceived using donor sperm. Participants included...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/j.rbmo.2017.06.012
更新日期:2017-10-01 00:00:00
abstract::A prospective randomized trial was performed to compare post-thaw development of murine blastocysts following programmable rate freezing and two methods of vitrification. Frozen 2-cell murine embryos (n = 429) thawed and cultured for 48 h, were randomly allocated by stage of development into four groups: control (not ...
journal_title:Reproductive biomedicine online
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s1472-6483(10)61103-0
更新日期:2004-05-01 00:00:00
abstract::In this prospective randomized study, women with idiopathic karyotypically normal premature ovarian failure (POF) were treated with gonadotrophin-releasing hormone (GnRH) agonist and gonadotrophins with and without the addition of corticosteroids in an attempt to restore ovarian function. The study comprised 58 women ...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章,随机对照试验
doi:10.1016/s1472-6483(10)60711-0
更新日期:2007-08-01 00:00:00
abstract::Aurora kinases comprise a family of phosphoproteins performing multiple functions in mitosis and meiosis. Because Aurora kinase B (AURKB) expression is altered in aged oocytes and there is only limited information on its function in meiosis, it was decided to study the spatial distribution and co-localization of AURKB...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/s1472-6483(10)60169-1
更新日期:2009-09-01 00:00:00
abstract::Glucose uptake was used as a measure of metabolic activity and implantation potential to compare vitrification and slow freezing in a prospective randomized trial using murine blastocysts. Frozen 2-cell embryos (n = 132) thawed and cultured for 48 h to the blastocyst stage were randomly divided into four groups: (i) c...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/s1472-6483(10)61168-6
更新日期:2005-11-01 00:00:00
abstract::The aetiology of endometriosis, a gynaecological disease defined by the histological presence of endometrial glands and stroma outside the uterine cavity, is still open to debate. Research has recently found evidence for endometriosis in human female fetuses at different gestational ages. This paper reports a new case...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/j.rbmo.2010.04.002
更新日期:2010-07-01 00:00:00
abstract::Human cloning, organ cloning and tissue cloning are various types of cloning that occur at different levels with different methodologies. According to three standards of terminology for an embryo (fertilization through germ cells, development in the uterus and having the potential to produce a human life), tissue clon...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/s1472-6483(10)61292-8
更新日期:2005-07-01 00:00:00
abstract:RESEARCH QUESTION:Does the time interval between the last gonadotrophin-releasing hormone (GnRH) antagonist dose and the GnRH agonist trigger affect the efficacy of the trigger in IVF treatments? DESIGN:This retrospective cohort study involved 53 normogonadotrophic patients undergoing GnRH antagonist-based IVF cycles,...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/j.rbmo.2020.08.004
更新日期:2020-11-01 00:00:00
abstract::Recurrent pregnancy loss (RPL) is defined by two or more failed pregnancies and accounts for only 1-5% of pregnancy failures. Treatment options for unexplained RPL (uRPL) are limited. Previous studies suggest a link between delayed implantation and pregnancy loss. Based on this, a timely signal for rescue of the corpu...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/j.rbmo.2016.11.016
更新日期:2017-03-01 00:00:00
abstract::A cohort follow-up study was designed to compare the efficacy of IVF using frozen donor semen (IVF-D) following previously failed DI cycles (unexplained female infertility) and direct IVF-D treatment because of tubal infertility (control group). The cohort comprised 189 couples initiating IVF-D after previously failed...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/s1472-6483(10)61275-8
更新日期:2004-10-01 00:00:00
abstract::Endometrial receptivity is a prerequisite for blastocyst implantation. During receptivity, the hairy-like epithelial cell microvilli transiently fuse to a single flower-like membrane projection called the 'pinopode'. Scanning electron microscopy in sequential endometrial biopsies shows that pinopodes appear about 1 we...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章,评审
doi:10.1016/s1472-6483(12)60111-4
更新日期:2002-01-01 00:00:00
abstract::An effective, consistent and xeno-free cryopreservation technique is crucial for any human embryonic stem cell (hESC) laboratory with future perspectives for clinical application. This study presents a new slow freezing-rapid thawing method in serum-free conditions that allows the cryopreservation of a large number of...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/s1472-6483(10)60302-1
更新日期:2008-07-01 00:00:00
abstract::This study aimed to investigate how hyperandrogenism affects early folliculogenesis. Hyperandrogenism was induced in prepuberal female BALB/c mice by daily s.c. injection of dehydroepiandrosterone (60 mg/kg body weight in 0.1 ml sesame oil) for 10 consecutive days. Although hyperandrogenism increased the growth rate o...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/j.rbmo.2010.02.012
更新日期:2010-06-01 00:00:00
abstract::The aim of this study was to evaluate the impact of gonadotrophin therapy in combination with intracytoplasmic sperm injection (ICSI) in men with hypogonadotrophic hypogonadism (HH). Twenty-five azoospermic men were diagnosed with HH due to low FSH, LH and total testosterone concentrations. These patients were treated...
journal_title:Reproductive biomedicine online
pub_type: 临床试验,杂志文章
doi:10.1016/s1472-6483(10)60703-1
更新日期:2007-08-01 00:00:00
abstract:RESEARCH QUESTION:There is some controversy regarding the impact of ovarian stimulation on immune cells in women undergoing IVF. The study's aim was to determine whether ovarian stimulation affected immune uterine cells in healthy women undergoing IVF. DESIGN:This prospective cohort study included 28 patients undergoi...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/j.rbmo.2019.08.004
更新日期:2020-01-01 00:00:00
abstract::This study describes and compares the possible effects of vitrification on the ultrastructural morphology of 20 human mature oocytes vitrified using two different supports, cryoleaf (n = 10) and cryoloop (n = 10). Fresh human mature oocytes (n = 15) were used as controls. Fresh and vitrified-warmed oocytes appeared ro...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/s1472-6483(10)60280-5
更新日期:2009-01-01 00:00:00
abstract::Early pregnancy loss (EPL) significantly reduces the initial success rate of assisted reproduction treatments and increases the psychological burden on the patient. The aim of the current study was to investigate the association between embryo quality and EPL in IVF. A retrospective study of 1471 women undergoing IVF ...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/s1472-6483(10)60637-2
更新日期:2006-10-01 00:00:00
abstract::Cell-free seminal mRNA (cfs-mRNA) contains testis-specific transcripts from bilateral testes. This study determined the presence of DEAD box polypeptide 4 (DDX4) in cfs-mRNA to identify and characterize the incidence of Sertoli cell-only (SCO) syndrome in men with non-obstructive azoospermia (NOA). DDX4 cfs-mRNA was d...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/j.rbmo.2016.05.001
更新日期:2016-08-01 00:00:00
abstract::Preimplantation genetic diagnosis (PGD) has recently been performed for inherited cancer predisposition determined by p53 tumour suppressor gene mutations, suggesting the usefulness of PGD for late onset disorders with genetic predisposition, including those caused by the germline mutations of other tumour suppressor ...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/s1472-6483(10)61809-3
更新日期:2002-05-01 00:00:00
abstract::This proceedings report presents the outcomes from an international Expert Meeting to establish a consensus on the recommended technical and operational requirements for air quality within modern assisted reproduction technology (ART) laboratories. Topics considered included design and construction of the facility, as...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/j.rbmo.2018.02.005
更新日期:2018-06-01 00:00:00
abstract::Cryptorchidism is the most frequent congenital anomaly of the urogenital tract in human males. INSL3 and LGR8/GREAT proteins seem to act as ligand and receptor respectively, and to have a role in gubernaculum development involved in testicular descent. Mutations in the INSL3 gene or LGR8/GREAT were found to be associa...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/s1472-6483(10)62144-x
更新日期:2004-09-01 00:00:00
abstract::Preimplantation genetic diagnosis (PGD) is an increasingly common adjunct to IVF. The information gained from PGD may be used to reduce the incidence of chromosomally abnormal pregnancies and augment the current selection process of embryos. As such, patients may choose to utilize PGD in either fresh or cryopreserved ...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/j.rbmo.2012.06.021
更新日期:2012-11-01 00:00:00
abstract::The relationship between endogenous LH concentrations and ongoing pregnancy rates among normogonadotrophic patients undergoing ovarian stimulation in a gonadotrophin-releasing hormone antagonist protocol were examined. In the Engage trial, 1506 patients received corifollitropin alfa (150 μg) or daily recombinant FSH (...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.rbmo.2011.06.015
更新日期:2011-10-01 00:00:00
abstract::Meta-analyses were conducted to investigate the relationship of sperm DNA fragmentation on pregnancy outcome using in-vivo fertilization, IUI, routine IVF and ICSI. Couples with no known infertility problems were 7.0 times (CI 3.17, 17.7) more likely to achieve a pregnancy/delivery if the DNA fragmentation index (DFI)...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章,meta分析
doi:10.1016/s1472-6483(10)62000-7
更新日期:2006-04-01 00:00:00
abstract::Meiotic spindles tether the chromosomes of oocytes and have been found to be structurally abnormal in older women. Conventional methods to image the meiotic spindle, such as immunostaining or transmission electron microscopy, require prior fixation, so they cannot be used clinically, and their utility in developmental...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章,评审
doi:10.1016/s1472-6483(10)61724-5
更新日期:2003-07-01 00:00:00
abstract::Somatic cloning by nuclear transfer returns a differentiated cell to a totipotent stage, a process termed nuclear reprogramming. During this de-differentiation process, genes inactivated during tissue differentiation are re-activated in a temporal and spatial special manner. It is believed that tissue differentiation ...
journal_title:Reproductive biomedicine online
pub_type: 杂志文章
doi:10.1016/s1472-6483(10)61095-4
更新日期:2004-05-01 00:00:00