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Polyzos N.P.,Vrije Universiteit Brussel | Camus M.,Vrije Universiteit Brussel | Llacer J.,Instituto Bernabeu | Pantos K.,Genesis Athens | Tournaye H.,Vrije Universiteit Brussel
BMJ Open | Year: 2013

Background: Poor response to ovarian stimulation affects a significant proportion of infertile couples undergoing in vitro fertilisation (IVF) treatment. Recently, the European Society of Human Reproduction and Embryology developed new criteria to define poor ovarian response, the so-called Bologna criteria. Although preliminary studies in these patients demonstrated very low pregnancy rates, a recent pilot study has shown promising results in women <40 years old fulfilling the criteria, after treatment with corifollitropin α followed by highly purified menotropin (hpHMG) in a gonadotropin- releasing hormone (GnRH) antagonist setting. Corifollitropin á followed by menotropin for poor ovarian responders' trial (COMPORT) is a randomised trial aiming to investigate whether this novel protocol is superior to treatment with recombinant follicle-stimulating hormone (FSH) in an antagonist setting for young poor responders. Methods/design: COMPORT is a multicentre, open label, phase III randomised trial using a parallel two-arm design. 150 patients <40 years old fulfilling the 'Bologna criteria ' will be randomised to corifollitropin α followed by hpHMG (group A) or recombinant FSH (group B) in a GnRH antagonist protocol for IVF/intracytoplasmic sperm injection (ICSI). The primary outcome is the ongoing pregnancy rate (defined as the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9-10 weeks of gestation). Secondary outcomes are clinical and biochemical pregnancy rates and number of oocytes retrieved. Central randomisation will be performed using a computer-generated list and allocation concealment will be secured with the use of sealed-opaque envelopes. A sample size of 150 women is essential to detect a difference of 19.5% in ongoing pregnancy rates between group A (28%) and group B (8.5%) with a power of 85% and a level of significance at 0.05 using a two-sided Fisher 's exact test.

Obruca A.,Kinderwunschzentrum Privatspital Goldenes Kreuz | Schenk M.,Kinderwunsch Institute Schenk GmbH | Tews G.,Landes Frauen und Kinderklinik Linz | Mardesic T.,Sanatorium Pronatal | And 20 more authors.
Reproductive BioMedicine Online | Year: 2010

In this double-blind, double-dummy, randomized, equivalence trial (Ensure), 396 women weighing 60 kg or less who underwent controlled ovarian stimulation prior to IVF or intracytoplasmic sperm injection were randomized in a 2:1 ratio to a single dose of 100 μg corifollitropin alfa or daily 150 IU recombinant FSH (rFSH) for the first 7 days of stimulation in a gonadotrophin-releasing hormone antagonist protocol. The mean ± SD number of oocytes retrieved per started cycle was 13.3 ± 7.3 for corifollitropin alfa versus 10.6 ± 5.9 for rFSH. The estimated treatment difference of +2.5 oocytes (95% CI 1.2-3.9) in favour of corifollitropin alfa (P < 0.001) was well within the predefined equivalence margin. The median (range) duration of stimulation was 9 (6-15) days in both groups. In 32.8% of the patients, one injection of corifollitropin alfa was sufficient to reach the human chorionic gonadotrophin criterion. The incidence of moderate and severe ovarian hyperstimulation syndrome was 3.4% for corifollitropin alfa and 1.6% for rFSH. A dose of 100 μg corifollitropin alfa offers a simplified treatment option for potential normal responder patients with a lower body weight. © 2010, Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

De Los Santos M.J.,IVI Valencia | Arroyo G.,Institute Universitari Dexeus | Busquet A.,Centro Ginecologico Santiago Dexeus | Calderon G.,IVI Barcelona | And 8 more authors.
Fertility and Sterility | Year: 2014

Objective To investigate the impact of early cleavage (EC) on embryo quality, implantation, and live-birth rates. Design Prospective cross-sectional study. Setting Multicenter study. Patient(s) Seven hundred embryo transfers and 1,028 early-stage human embryos. Intervention(s) None. Main Outcome Measure(s) Implantation according to the presence of EC and embryo quality. Result(s) The presence of EC is associated with embryo quality, especially in cycles with autologous oocytes. However, the use of EC as an additional criterion for selecting an embryo for transfer does not appear to significantly improve likelihood of implantation. Furthermore, embryos that presented EC had live-birth rates per implanted embryo similar to those that did not show any sign of cleavage. Conclusion(s) At least for conventional embryo culture and morphologic evaluations, the additional evaluation of EC in embryos may not be valuable to improve embryo implantation. © 2014 American Society for Reproductive Medicine, Published by Elsevier Inc. All rights reserved.

Mendiola J.,University of Murcia | Moreno J.M.,Technical University of Cartagena | Roca M.,University of Murcia | Vergara-Jurez N.,Technical University of Cartagena | And 9 more authors.
Environmental Health: A Global Access Science Source | Year: 2011

Background: Animal studies have shown the reproductive toxicity of a number of heavy metals. Very few human observational studies have analyzed the relationship between male reproductive function and heavy metal concentrations in diverse biological fluids. Methods. The current study assessed the associations between seminal and hormonal parameters and the concentration of the 3 most frequent heavy metal toxicants (lead, cadmium and mercury) in three different body fluids. Sixty one men attending infertility clinics that participated in a case-control study to explore the role of environmental toxins and lifestyles on male infertility were analyzed. Concentration of lead, cadmium and mercury were measured in blood and seminal plasma and whole blood using anodic stripping voltammetry and atomic absorption spectrophotometry. Serum samples were analyzed for follicle-stimulating hormone, luteinizing hormone and testosterone. Semen analyses were performed according to World Health Organization criteria. Mann-Whitney test and Spearman's rank correlations were used for unadjusted analyses. Multiple linear regression models were performed controlling for age, body mass index and number of cigarettes per day. Results: There were no significant differences between cases and controls in the concentrations of heavy metals in any of the three body fluids. In multivariate analyses using all subjects no significant associations were found between serum hormone levels and metal concentrations. However there was a significant positive association between the percentage of immotile sperms and seminal plasma levels of lead and cadmium. Conclusions: Our results suggest that the presence of lead and cadmium in the reproductive tract of men may be related to a moderate alteration of their seminal parameters. © 2011 Mendiola et al; licensee BioMed Central Ltd.

Marhuenda-Egea F.C.,University of Alicante | Gonsalvez-Alvarez R.D.,Instituto Bernabeu | Lledo-Bosch B.,Instituto Bernabeu | Ten J.,Instituto Bernabeu | Bernabeu R.,Instituto Bernabeu
Analytical Chemistry | Year: 2013

The search of metabolites which are present in biological samples and the comparison between different samples allow the construction of certain biochemical patterns. The mass spectrometry (MS) methodology applied to the analysis of biological samples makes it possible for the identification of many metabolites. Each obtained signal (m/z) is characteristic of a particular metabolite. However, the mass data (m/z) interpretation is difficult because of the large amount of information that they contain. In this work, we present a relatively simple tool that allows us to deal with the whole of the mass information from the chemometric analysis. The statistical analysis is a key stage in order to identify the metabolites involved in a particular biochemical pattern. We transformed the mass data matrix in a vector. By having the data as a vector, it was possible to keep all the information and also avoid the signals overlapping, which is the major problem when the total ion chromatogram (TIC) is obtained. In the approach proposed here, the mass data (m/z) matrix was split in 100 different TIC in order to avoid the signal overlapping. The 100 chromatograms were concatenated in a vector. This vector, which can be plotted as a continuous (2D pseudospectrum), greatly simplifies for one to understand the subsequent dimensional multivariate analysis. To validate the method, 19 samples from two human embryos culture medium were analyzed by high-pressure liquid chromatography-mass spectrometry (HPLC-MS). Our methodology would be applied to the obtained raw data. Later on, a multivariate analysis was conducted using a robust principal components analysis interval (robPCA) and interval partial least squares algorithm (iPLS). The results obtained allow one to differentiate the two sample populations undoubtedly, although their composition was similar. © 2013 American Chemical Society.

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