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Worrilow K.C.,Pennsylvania State University | Worrilow K.C.,KC Worrilow and Associates LLC | Eid S.,KC Worrilow and Associates LLC | Woodhouse D.,Fertility Center | And 6 more authors.
Human Reproduction | Year: 2013

Study Question Does the selection of sperm for ICSI based on their ability to bind to hyaluronan improve the clinical pregnancy rates (CPR) (primary end-point), implantation (IR) and pregnancy loss rates (PLR)? Summary Answer In couples where ≤65% of sperm bound hyaluronan, the selection of hyaluronan-bound (HB) sperm for ICSI led to a statistically significant reduction in PLR.WHAT IS KNOWN AND WHAT THIS PAPER ADDSHB sperm demonstrate enhanced developmental parameters which have been associated with successful fertilization and embryogenesis. Sperm selected for ICSI using a liquid source of hyaluronan achieved an improvement in IR. A pilot study by the primary author demonstrated that the use of HB sperm in ICSI was associated with improved CPR. The current study represents the single largest prospective, multicenter, double-blinded and randomized controlled trial to evaluate the use of hyaluronan in the selection of sperm for ICSI.DESIGNUsing the hyaluronan binding assay, an HB score was determined for the fresh or initial (I-HB) and processed or final semen specimen (F-HB). Patients were classified as >65% or ≤65% I-HB and stratified accordingly. Patients with I-HB scores ≤65% were randomized into control and HB selection (HYAL) groups whereas patients with I-HB >65% were randomized to non-participatory (NP), control or HYAL groups, in a ratio of 2:1:1. The NP group was included in the >65% study arm to balance the higher prevalence of patients with I-HB scores >65%. In the control group, oocytes received sperm selected via the conventional assessment of motility and morphology. In the HYAL group, HB sperm meeting the same visual criteria were selected for injection. Patient participants and clinical care providers were blinded to group assignment.PARTICIPANTS AND SETTINGEight hundred two couples treated with ICSI in 10 private and hospital-based IVF programs were enrolled in this study. Of the 484 patients stratified to the I-HB > 65% arm, 115 participants were randomized to the control group, 122 participants were randomized to the HYAL group and 247 participants were randomized to the NP group. Of the 318 patients stratified to the I-HB ≤ 65% arm, 164 participants were randomized to the control group and 154 participants were randomized to the HYAL group. Main Results and the Role of Chance HYAL patients with an F-HB score ≤65% demonstrated an IR of 37.4% compared with 30.7% for control [n = 63, 58, P > 0.05, (95% CI of the difference-7.7 to 21.3)]. In addition, the CPR associated with patients randomized to the HYAL group was 50.8% when compared with 37.9% for those randomized to the control group (n = 63, 58, P > 0.05). The 12.9% difference was associated with a risk ratio (RR) of 1.340 (RR 95% CI 0.89-2.0). HYAL patients with I-HB and F-HB scores ≤65% revealed a statistically significant reduction in their PLR (I-HB: 3.3 versus 15.1%, n = 73, 60, P = 0.021, RR of 0.22 (RR 95% CI 0.05-0.96) (F-HB: 0.0%, 18.5%, n = 27, 32, P = 0.016, RR not applicable due to 0.0% value) over control patients. The study was originally planned to have 200 participants per arm providing 86.1% power to detect an increase in CPR from 35 to 50% at a = 0.05 but was stopped early for financial reasons. As a pilot study had demonstrated that sperm preparation protocols may increase the HB score, the design of the current study incorporated a priori collection and analysis of the data by both the I-HB and the F-HB scores. Analysis by both the I-HB and F-HB score acknowledged the potential impact of sperm preparation protocols.BIAS, CONFOUNDING AND OTHER REASONS FOR CAUTIONSelection bias was controlled by randomization. Geographic and seasonal bias was controlled by recruiting from 10 geographically unique sites and by sampling over a 2-year period. The potential for population effect was controlled by adjusting for higher prevalence rates of >65% I-HB that naturally occur by adding the NP arm and to concurrently recruit >65% and ≤65% I-HB subjects. Monitoring and site audits occurred regularly to ensure standardization of data collection, adherence to the study protocol and subject recruitment. Subgroup analysis based on the F-HB score was envisaged in the Study Design .GENERALIZABILITY TO OTHER POPULATIONSThe study included clinics using different sperm preparation Method s, located in different regions of the USA and proceeded in every month of the year. Therefore, the results are widely applicable. Study Funding/Competing Interest (S)This study was funded by Biocoat, Inc., Horsham, PA, USA. The statistical analysis plan and subsequent analyses were performed by Sherrine Eid, a biostatistician. The manuscript was prepared by Kathryn C. Worrilow, Ph.D. and the study team members. Biocoat, Inc. was permitted to review the manuscript and suggest changes, but the final decision on content was exclusively retained by the authors. K.C.W is a scientific advisor to Biocoat, Inc. S.E. is a consultant to Biocoat, Inc. D.W. has nothing to disclose. M.P., S.S., J.W., K.I., C.K. and T.E. have nothing to disclose. G.D.B. is a consultant to Cooper Surgical and Unisense. J.L. is on the scientific advisory board of Origio. Trial Registration Number NCT00741494. © 2012 The Author. Source


Lawrenz B.,Fertility Center
Gynakologische Endokrinologie | Year: 2015

In recent years the aspect of quality of life for long-term survivors of cancer has become increasingly more important for oncologists and patients. A very important aspect of the quality of life is the possibility of founding a family. One of the most detrimental effects of chemotherapy is impairment or even loss of ovarian function and therefore of fertility. Meanwhile, with the advances in reproductive medicine techniques are available which can be implemented in the oncological regimen to preserve fertility without delay of chemotherapy and without a negative impact on health. To realize the implementation of fertility preserving methods in the oncological regimen it is of utmost importance to have close collaboration between the oncologist and the reproductive medicine specialist and early counseling of the patient. © 2015, Springer-Verlag Berlin Heidelberg. Source


Jasiczek D.,Fertility Center | Kaim I.,CMUJ | Czajkowski K.,Medical University of Warsaw
Neuroendocrinology Letters | Year: 2012

The essence of life is best manifested in cell, which, when brought to the edge of its existence in the actual environment may and sometimes must self-organise into an entirely different cell (neoplasm), but it must enhance dissipation of matter and energy in its closest environment. This phenomenon has been described before as self-organisation of dissipative structures in physics, chemistry and even sociology. Each neoplastic cell is such a dissipative system - with its clonal growth, the cell causes increasing disorganisation of the body, in consequence leading to neoplastic disease. The only adequate cause of formation of neoplasms is an internal dissipathogenic cellular state, which is clinically identify as preneoplastic ones at the level of morphology or molecular biology but also biophysics. Two general directions for therapy of neoplastic diseases arise from the thermodynamic essence of neogenesis: the direct one - targeting neoplasms, and the indirect one - leading to normalisation or sufficient alteration of their environment. The greatest disappointment in the fight against neoplasm was the discovery of its thermodynamic cause in a natural self-organisation of biological dissipative structures. It is this dissipation that causes the signs and symptoms of neoplastic diseases ending with destruction of the body if the treatment comes too late and/or is insufficient, limited only to removal of neoplastic lesions without the always necessary elimination and/or prevention of preneoplastic (dissipathogenic) states. © 2012 Neuroendocrinology Letters. Source


Tournaye H.J.,Center for Reproductive Medicine | Cohlen B.J.,Fertility Center
Best Practice and Research: Clinical Obstetrics and Gynaecology | Year: 2012

For many years, the management of male-factor infertility has been empirical rather than evidence-based. In current clinical practice, assisted reproductive techniques are the most successful methods of alleviating male-factor infertility. To date, it remains unclear what adjuvant actions can be taken to improve the outcome of assisted reproductive techniques for male-factor infertility. Evidence shows that smoking adversely affects sperm quality to some extent, and the genetic make-up of sperm to a greater extent; however, because of the scarcity and heterogeneity of studies, its effect on in-vitro fertilisation outcome remains largely unknown. Although smoking cessation should be part of the assisted reproductive techniques treatment plan, the benefit of antioxidant treatment in either smokers or non-smokers undergoing assisted reproductive techniques is still under scrutiny. Other lifestyle modifications in subfertile men, such as refraining from moderate alcohol and caffeine consumption, are even more controversial. When embarking on assisted reproductive techniques to alleviate male-factor infertility, intrauterine insemination may be considered as a first-line treatment for couples in whom the female partner has a normal fertility status, and at least 0.8 × 106 progressively motile spermatozoa are recovered after sperm preparation. If no pregnancy is achieved after three to six cycles of intrauterine insemination, in-vitro fertilisation can be proposed. When too few progressively motile spermatozoa are obtained after sperm processing for in-vitro fertilisation, or when surgically retrieved sperm are to be used, intracytoplasmic sperm injection is preferable. Although the outcome of no other assisted reproductive techniques has been scrutinised so much, and no large-scale 'macro-problems' have yet been observed after intracytoplasmic sperm injection, malformation rates are reported to be higher compared with the general population. Therefore, candidates for intracytoplasmic sperm injection should be rigorously screened before embarking on in-vitro fertilisation or intracytoplasmic sperm injection, and thoroughly informed of the limitations of our knowledge on the hereditary aspects of male infertility and the safety aspects of assisted reproductive techniques. Source


Tomas C.,Fertility Center | Alsbjerg B.,Fertility Clinic | Martikainen H.,University of Oulu | Humaidan P.,University of Southern Denmark
Fertility and Sterility | Year: 2012

Objective: To compare the reproductive outcome of three protocols for frozen ET treatment. Design: Retrospective follow-up study. Setting: Two public clinics and one private clinic. Patient(s): Four thousand four hundred seventy frozen ET cycles between 2006 and 2010. Intervention(s): Thawing of embryos and ET. Main Outcome Measure(s): Pregnancy test rate, clinical pregnancy rate, and pregnancy loss rate. Result(s): The natural cycle followed by P (NC + P) was used in 26% of cycles, the natural cycle with hCG (NC + hCG) in 10%, and the substituted cycle with estrogen and P (E + P) in 64% of cycles. The rate of transfers after thawing was similar in all groups (87.2%, 73.9%, and 87.2%, respectively). There was a significantly higher positive pregnancy test rate in the E + P (34.3%) and NC + hCG (35.5%) cycles as compared with the NC + P cycles (26.7%). However, the clinical pregnancy rate was similar in all groups (27.7%, 29.1%, and 24.3%, respectively). Moreover, no differences were seen between groups regarding the live-birth rate (20.1%, 23.5%, and 20.7%, respectively). A logistic regression analysis showed that the type of protocol was the only predictor of pregnancy loss, while age, irregular cycles, endometrial thickness, number, and quality of embryos transferred did not correlate to pregnancy loss. Conclusion(s): A higher positive pregnancy test rate was obtained in E + P frozen ET cycles in comparison with other protocols; however, due to an increased preclinical and clinical pregnancy loss, comparable clinical pregnancy, and delivery rates are reported for the three protocols. Copyright © 2012 American Society for Reproductive Medicine, Published by Elsevier Inc. Source

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