Global Clinical Research
Global Clinical Research
Aberer W.,Medical University of Graz |
Maurer M.,Charité - Medical University of Berlin |
Reshef A.,Clinical Immunology and Angioedema Unit |
Longhurst H.,Barts and the London Hospital |
And 5 more authors.
Allergy: European Journal of Allergy and Clinical Immunology | Year: 2014
Background: Historically, treatment for hereditary angioedema (HAE) attacks has been administered by healthcare professionals (HCPs). Patient self-administration could reduce delays between symptom onset and treatment, and attack burden. The primary objective was to assess the safety of self-administered icatibant in patients with HAE type I or II. Secondary objectives included patient convenience and clinical efficacy of self-administration. Methods: In this phase IIIb, open-label, multicenter study, adult patients were trained to self-administer a single 30-mg icatibant subcutaneous injection to treat their next attack. Icatibant-naïve patients were treated by an HCP prior to self-administration. Evaluations included adverse event (AE) reporting, a validated questionnaire for convenience, and visual analog scale for efficacy. Results: A total of 151 patients were enrolled; 104 had an attack requiring treatment during the study, and 97 patients (19 naïve) were included in the self-administration cohort. Recurrence or worsening of HAE symptoms (22 of 97) was the most commonly reported AE; rescue medications including icatibant (N = 3) and C1-inhibitor concentrate (N = 6) were used in 13 cases. Overall, 89 of 97 patients used a single injection of icatibant. No serious AEs or hospitalizations were reported. Most patients (91.7%) found self-administration preferable to administration in the clinic. The median time to symptom relief (3.8 h) was comparable with results from controlled trials of icatibant. Conclusions: With appropriate training, patients were successfully able to recognize HAE attacks and decide when to self-administer icatibant. This, coupled with the patient-reported high degree of satisfaction, convenience and ease of use supports the adoption of icatibant self-administration in clinical practice. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Lambers Heerspink H.J.,University of Groningen |
De Zeeuw D.,University of Groningen |
Wie L.,Bristol Myers Squibb |
Leslie B.,Global Clinical Research |
List J.,Global Clinical Research
Diabetes, Obesity and Metabolism | Year: 2013
Aims: Sodium-glucose co-transporter 2 (SGLT2) reabsorbs glucose and sodium in the renal proximal tubule. Dapagliflozin, an SGLT2 inhibitor, targets hyperglycaemia in type 2 diabetes by increasing renal glucose excretion. To investigate whether the parallel occurring sodium loss would have diuretic-like physiologic effects, we compared dapagliflozin and hydrochlorothiazide (HCTZ) effects on 24-h blood pressure (BP), body weight, plasma volume and glomerular filtration rate (GFR). Methods: In this randomized, placebo-controlled, double-blind trial, 75 subjects with type 2 diabetes were assigned placebo, dapagliflozin 10mg/day, or HCTZ 25mg/day. Changes from baseline BP, body weight, plasma volume and GFR were assessed after 12weeks of treatment. Results: Subjects' mean age was 56years, type 2 diabetes mellitus (T2DM) duration 6.3years, and haemoglobin A1c (HbA1c) 7.5%. Treatment with placebo, dapagliflozin or HCTZ resulted in changes from baseline in 24-h ambulatory mean systolic blood pressure (SBP) of -0.9 (95%CI -4.2, +2.4), -3.3 (95%CI -6.8, +0.2), and -6.6 (95%CI -9.9, -3.2) mmHg, respectively at week 12, adjusted for baseline SBP. Body weight decreased with dapagliflozin and HCTZ. In a sub-study plasma volume appeared to decrease with dapagliflozin but did not change with placebo or HCTZ treatment. Dapagliflozin induced a greater reduction in GFR (-10.8%; 95%CI -14.6, -6.7) relative to placebo (-2.9%; 95% CI -6.9, +1.2) or HCTZ (-3.4%; 95%CI -7.3, +0.6). Conclusions: Dapagliflozin-induced SGLT2 inhibition for 12weeks is associated with reductions in 24-h BP, body weight, GFR and possibly plasma volume. Cumulatively, these effects suggest that dapagliflozin may have a diuretic-like capacity to lower BP in addition to beneficial effects on glycaemic control. © 2013 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
News Article | February 15, 2017
Bioclinica®, a provider of specialized science and technology-enabled services supporting clinical trials, today announced three executive additions to its global Medical Imaging & Biomarkers leadership team. With global headquarters in Princeton, New Jersey, Bioclinica’s Medical Imaging & Biomarkers business segment is the world clinical trial leader in medical imaging, providing cardiac safety monitoring services, specialized biochemical marker analysis, and clinical lab services in the Bioclinica molecular marker laboratory. Joining Bioclinica are Andrew Kraus, Chief Operating Officer; Souhil Zaim, MD, Head of Global Medical and Science Affairs; and Sara Levy, Vice President, Client Services. All three will report to David Herron, President, Medical Imaging & Biomarkers. “As the global leader in medical imaging and biomarkers, our teams are proud to have supported more than 3,000 clinical trials and 149 FDA approvals. An incomparable clinical trial track record spanning three decades attracts the world’s best in our domain,” commented David Herron, President Medical Imaging & Biomarkers. “I am very happy to have these three, multi-talented individuals join our incredible team, adding their expertise, experience and passion for creating value for patients, customers and the industry.” Kraus is a recognized clinical research industry senior executive with more than 24 years of technical and regulatory knowledge, and a track record of financial growth and operational delivery. Among his primary responsibilities Kraus will be pivotal in driving strategic planning, spearheading technology-enabled global operations, supporting Bioclinica’s tremendous growth, and driving superior outcomes for clients. Most recently, Kraus was chief operating officer and treasurer of the Cardiovascular Research Foundation in New York City where he led a period of historical growth. Prior to this he was with ICON, plc. for ten years serving as executive vice president, Global Data Technologies after a tenure as executive vice president and chief technology officer of the Medical Imaging Division. Kraus has co-founded two successful businesses in the clinical trials services industry after beginning his long career at Bio-Imaging Technologies, which would later become Bioclinica. Kraus has both a bachelor’s and a master’s degree in Bioengineering from the University of Pennsylvania. Dr. Zaim is a recognized medical imaging industry senior executive with more than 25 years of medical, scientific and industry experience and was most recently chief medical officer at Median Technologies. He will be responsible for ensuring the strategic and long-term medical, scientific and technical development of Bioclinica’s Medical and Science Affairs organization in concert with the Medical Imaging & Biomarkers’ Chief Medical Officer, Dr. Michael O’Neal, and Chief Science Officer, Dr. Thomas Fuerst. Dr. Zaim was previously with SYNARC (merged with Bioclinica in March 2014) for more than a decade in various leadership roles, including medical director, chief medical officer, vice president of radiology, and director of radiology services, Europe. In these roles, Dr. Zaim established and developed global medical and science affairs teams supporting an array of clinical trial indications. Dr. Zaim is regularly published in peer-reviewed journals, and has extensive central reading and adjudication experience encompassing thousands of patients in hundreds of clinical trials in Oncology, Arthritis, Osteoporosis and other areas. Prior to this he was assistant professor of Radiology at the University of California at San Francisco. He earned a medical degree from the University of Algiers and is board certified in Radiology with a certificate in Magnetic Resonance, both from the University of Paris. Dr. Zaim is a member of the Radiological Society of North America, the European Society of Radiology, Osteoarthritis Research Society International, and the American Society of Clinical Oncology. Levy is a proven clinical research operating executive with more than 18 years of client and clinical data management experience. She was most recently clinical practice director at Penobscot Community Health Center leading a health service delivery venture with athenahealth. She will provide executive leadership for Bioclinica’s clinical project management teams across the Medical Imaging & Biomarker business, supporting operations and delivery focused on consistency of service and customer satisfaction, and will play a pivotal role in the ongoing development of new client-service offerings. Levy is a graduate of Trinity College with a Bachelor of Science degree in Psychology and Cognitive Science with a focus on the neurosciences. About Bioclinica Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment is the global clinical trial leader in medical imaging, providing cardiac safety monitoring services, specialized biochemical marker analysis and clinical lab services in the Bioclinica molecular marker laboratory. The eHealth Solutions segment comprises an eClinical technology platform and professional services along with safety and regulatory solutions. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment-retention services, and a post-approval research division. The Company serves more than 400 pharmaceutical, biotechnology and device organizations – including all of the top 20 – through a network of offices in the U.S., Europe and Asia. Learn more about Bioclinica at http://www.bioclinica.com.
De Greef R.,Merck Research Labs |
Zandvliet A.S.,Merck Research Labs |
De Haan A.F.J.,Biostatistics and Research Decision science BARDS |
Ijzerman-Boon P.C.,Biostatistics and Research Decision science BARDS |
And 2 more authors.
Clinical Pharmacology and Therapeutics | Year: 2010
In controlled ovarian stimulation (COS), a single subcutaneous dose of corifollitropin alfa is used to initiate and sustain multifollicular growth for 7 days. The objective of this study was to determine the optimal dose of corifollitropin alfa. A pharmacokinetic model was developed to describe the time profile of corifollitropin alfa concentrations. Multiple parameters reflecting ovarian response were included in a pharmacokinetic-pharmacodynamic (PK-PD) model framework. An early decline in serum inhibin B was shown to be a sensitive marker for COS failure. Simulations were performed to select the lowest corifollitropin alfa dose that would result in a minimal cancellation rate: 100μg for a group of women weighing 60kg and 150μg for a group of women weighing 60kg. With these doses, the predicted mean number of oocytes per started COS cycle was similar in the two groups, i.e., 12.1 and 13.2, respectively. The selected doses were tested in prospective clinical trials and were proven to be adequate. © 2010 American Society for Clinical Pharmacology and Therapeutics.
Fauser B.C.J.M.,University Utrecht |
Alper M.M.,Harvard University |
Ledger W.,University of Sheffield |
Schoolcraft W.B.,Colorado Center for Reproductive Medicine |
And 2 more authors.
Reproductive BioMedicine Online | Year: 2010
A single injection of corifollitropin alfa can replace seven daily injections of recombinant FSH (rFSH) using a gonadotrophin-releasing hormone antagonist protocol in ovarian stimulation prior to IVF or intracytoplasmic sperm injection. This double-blind randomized controlled trial assessed the pharmacokinetics and pharmacodynamics of 150 μg corifollitropin alfa versus daily 200 IU rFSH in 1509 patients. Comparative analyses were performed on serum concentrations of FSH immunoreactivity (pharmacokinetics), and the number and size of growing follicles, and inhibin B and oestradiol concentrations as biomarkers of ovarian response (pharmacodynamics). The rate of follicular development was similar in both treatment groups. By stimulation day 8, 33% of patients treated with corifollitropin alfa reached the criterion for human chorionic gonadotrophin (HCG) injection. The number of follicles ≥11 mm was slightly higher after corifollitropin alfa compared with daily rFSH at stimulation day 8 (difference, 1.2; 95% confidence interval (CI) 0.5-1.8; P < 0.01) and on the day of HCG injection (difference, 2.1; 95% CI 1.4-2.8; P < 0.01). The rise of inhibin B and oestradiol concentrations was similar in both treatment groups. Although the pharmacokinetics of corifollitropin alfa and rFSH are quite different their pharmacodynamic profiles at the dosages used are similar. A single injection of corifollitropin alfa can replace seven daily injections of recombinant FSH (rFSH) using a gonadotrophin-releasing hormone antagonist protocol in ovarian stimulation prior to IVF or intracytoplasmic sperm injection. The objective of this study was to compare the pharmacokinetics and pharmacodynamics of corifollitropin alfa versus daily rFSH. A total of 1509 patients were randomized in a double-blind, controlled trial to either a single injection of 150 μg corifollitropin alfa or to daily injections of 200 IU rFSH for the first 7 days of ovarian stimulation. Serum levels of FSH immunoreactivity were analysed (pharmacokinetic analysis), together with the number and size of growing follicles and serum inhibin B and oestradiol concentrations as biomarkers of the ovarian response (pharmacodynamic analysis). Serum FSH immunoreactivity levels were higher up to stimulation day 5 for corifollitropin alfa compared with the daily rFSH regimen but were similar from day 8 onwards, when patients started rFSH if the criteria for human chorionic gonadotrophin were not yet reached. Corifollitropin alfa treatment resulted in a similar growth rate of follicles though a slightly higher number of follicles were recruited compared with daily rFSH. It is concluded that the pharmacokinetics of corifollitropin alfa and rFSH are quite different but their induced pharmacodynamic effects at the dosages used are similar. © 2010, Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.
News Article | February 21, 2017
Bioclinica®, a leading provider of technology-enabled clinical trial solutions, today announced the further expansion of its eHealth App xChange™, providing clinical researchers more choices in the types of applications they can leverage as part of Bioclinica’s extensive and growing eHealth platform. Applications that enable patient-centered clinical trials make up the fastest-growing App xChange category and include a variety of patient engagement tools. Additionally, partners bringing advanced analytics and machine learning capabilities aimed at reducing risks and improving process and workflow efficiencies are increasingly joining Bioclinica’s App xChange. Established in 2015 to spur clinical trial innovation, App xChange creates an environment for collaboration among technology providers, and allows sponsors to leverage the value of integration within Bioclinica’s secure, validated eHealth Cloud™. “Recognizing the shift in the bio-pharma industry to an increased number of stakeholders and differing priorities, we’ve expanded our partner approach to a wider array of technology providers that can help the industry drive transformational change,” says Bioclinica’s Vice President Technology Alliances, eHealth Solutions, Anne Zielinski. Currently 18 partners are in the eHealth App xChange, a complete listing of which can be viewed in Bioclinica’s dynamic eHealth App xChange portal. Partners include ArisGlobal, Medelinked, Vitrana, AiCure, and Parallel 6. Among the newest partners are mProve, Be the Partner, and DupCheck. They bring diverse capabilities including: patient recruitment; electronic informed consent; ePRO; source data capture; eTMF; electronic patient diaries; patient alerts and reminders; medication adherence; patient feedback tools; pharmacovigilance; duplicate enrollment checking; predictive analytics; and remote training. “Bioclinica is a pioneer,” says Jonathan Rabinowitz, founder and CEO of DupCheck, whose technology screens out duplicate subjects across sponsors and clinical trials globally, and can be integrated with Bioclinica’s Trident RTSM and Express EDC. “Bioclinica App xChange addresses the problem of disparate systems, and enables research organizations to leverage remarkable tools without adding site fatigue or burdening research organizations.” “As technology is evolving at such a rapid pace, we have a rigorous vetting process, as well as the connectivity and integration capability, to evaluate offerings and make them readily available to the industry,” Zielinski explains. “As heightened interest by potential partners wanting to become part of the Bioclinica eHealth platform coincides with growing interest by sponsors and CROs, everything is aligning for clinical researchers to reap the benefits of innovation for effective clinical development with increased efficiencies and reduced risk.” A number of partner technologies are available in the eHealth Cloud, addressing security, and compliance and validation requirements. Tapping Bioclinica for these technologies can streamline the contracting process, making one less vendor sponsors must manage. Bioclinica offers enabling professional and technology services to recognize the full value of its eHealth platform and help ensure successful implementation of partner applications, complete with hosting and help desk services. As for what is next, Zielinski says she and the eHealth Solutions team are continually evaluating potential partners from a value and integration standpoint, and are aggressively exploring new opportunities in areas such as eSource and site-focused solutions that can advance the 21st Century Cures Act. “Our aim is to bring added value to the research process, whether that’s tools used by the patient, site, sponsor or CRO, and to remain the leader in technology-enabled clinical trials with the most extensive eHealth platform.” Bioclinica will showcase App xChange partners at the European eHealth Conference on February 22-23. Visit the event site to learn more about App xChange and other Bioclinica solutions. To schedule an online or live App xChange demonstration, email Anne.Zielinski(at)Bioclinica(dot)com. Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. The eHealth Solutions segment comprises the eClinical Solutions platform; Financial Lifecycle Solutions; Safety and Regulatory Solutions; Strategic Consulting Services; App xChange Alliances; and eHealth Cloud Services. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment services, and a post-approval research division. The Company serves more than 400 pharmaceutical, biotechnology and device organizations – including all of the top 20 – through a network of offices in the U.S., Europe and Asia. Learn more at http://www.Bioclinica.com.
News Article | November 8, 2016
Bioclinica®, a provider of specialized technology-enabled services supporting clinical research, today announced that Premier Research has standardized on two Bioclinica Financial Lifecycle Solutions technologies in its eHealth platform for investigator payment management. Last year, the leading contract research organization (CRO) adopted Bioclinica ClinPay® enterprise-wide as its site payment automation solution, and has since begun using ClinPlan® for budget management and cash forecasting. Bioclinica and Premier Research co-presented a case study detailing the impressive results in a recent Xtalks webinar. In it, Jay Trepanier, Senior Vice President and General Manager, Bioclinica Financial Lifecycle Solutions, and Jim Sacchetta, Manager, Technical Operations, Premier Research shared their extensive experience in financial management and forecasting in clinical trials. A recording of the live event can be accessed here: Clinical Trial Forecasting: Managing the Challenges and Avoiding the Fines. “Having ClinPay named as Premier Research’s de facto site payment automation solution and ClinPlan as its budget management and forecasting tool comes as a strong endorsement, and is consistent with growing adoption of Bioclinica Financial Lifecycle Solutions across the industry,” said Trepanier. “Accurately managing and forecasting investigator payments is essential to successful clinical trials, and with ClinPay we’re able to achieve this, while greatly reducing administrative effort and probability of error,” said Charlie Nicholson, Chief Financial Officer, Premier Research. The CRO operates in 84 countries, making ClinPay’s ability to pay in local currencies an asset. “As investigator fees represent, on average, 40 percent of a study’s total budget, we needed to have control over the process. ClinPay made an immediate and profound impact, significantly reducing workload and operational costs, while boosting sponsor and site satisfaction by speeding accurate payments to sites.” ClinPay is part of an innovative and open-integration platform unrivaled in its ability to automate the entire financial lifecycle of global clinical trials. The platform’s extensive core functionality encompasses contract term management, budget planning, expense forecasting, cash flow management, site and vendor payments, and subject reimbursement. One of ClinPay’s key features is ease of integration with Bioclinica Express and all other major Electronic Data Capture (EDC) systems on the market. To request a product demonstration of ClinPay, ClinPlan and other Financial Lifecycle Solutions in the Bioclinica eHealth platform, contact Bioclinica Financial Lifecycle Solutions. About Premier Research Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideas to reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, dermatology, medical devices, neuroscience, oncology, pediatrics, and rare disease. Premier Research operates in 84 countries and employs 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. They are focused on smart study design for advanced medicines that allow life-changing treatments. About Bioclinica Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. The eHealth Solutions segment comprises the eClinical Solutions platform; Financial Lifecycle Solutions; Safety and Regulatory Solutions; Strategic Consulting Services; App xChange Alliances; and eHealth Cloud Services. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment-retention services, and a post-approval research division. The Company serves more than 400 pharmaceutical, biotechnology and device organizations – including all of the top 20 – through a network of offices in the U.S., Europe and Asia. Learn more at http://www.bioclinica.com.
Doody K.J.,Center for Assisted Reproduction |
Devroey P.,Universitair Ziekenhuis Brussel |
Leader A.,University of Ottawa |
Witjes H.,Biostatistics and Research Decision science |
Mannaerts B.M.,Global Clinical Research
Reproductive BioMedicine Online | Year: 2011
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 (rFSH) (200 IU) for the first 7 days of stimulation with 0.25 mg ganirelix from stimulation day 5. Patients were retrospectively stratified by serum LH percentiles (<25th, 25th-75th and >75th) on stimulation day 8 and day of human chorionic gonadotrophin administration. Odds ratios (OR) with and without adjustment for predictive factors for ongoing pregnancy were estimated. LH concentration was not associated with pregnancy rates in either treatment arm, in contrast to ovarian response and serum progesterone. With adjustment for these predictors and age, OR (95% confidence interval) for ongoing pregnancy on stimulation day 8 for LH categories
Andersen A.N.,Copenhagen University |
Witjes H.,Biostatistics and Research Decision science |
Gordon K.,Merck And Co. |
Mannaerts B.,Global Clinical Research
Human Reproduction | Year: 2011
Background: Prediction of ovarian response prior to the first controlled ovarian stimulation (COS) cycle is useful in determining the optimal starting dose of recombinant FSH (rFSH). However, potentially predictive factors may be subject to inter-cycle variability and many patients are pre-treated with oral contraceptives (OC) for scheduling purposes. Our objective was to determine predictive factors of ovarian response for patients undergoing COS with rFSH in a gonadotrophin-releasing hormone antagonist protocol and to determine the inter-cycle variability of these factors.Methods: In this multinational trial, 442 patients were randomized to receive either OC treatment or no treatment prior to their first COS cycle. For candidate predictive factors, patient characteristics were collected at screening, and endocrine and sonographic data were collected during the early follicular phase of the two subsequent cycles. A treatment regimen of 200 IU rFSH and 0.25 mg ganirelix was applied during the second cycle. Predictive factors of ovarian response and of too low (<6 oocytes) or too high (>18 oocytes) ovarian responses were determined using stepwise linear regression and stepwise logistic regression, respectively.Results: Anti-Mllerian hormone (AMH) and basal FSH were statistically significant predictors of the number of oocytes retrieved and of an excessive ovarian response. For low ovarian response, AMH was the only significant predictive factor. In the non-OC group, the predictive value was higher than in the OC group and higher at the early follicular phase of the stimulation cycle than of the previous cycle. The inter-cycle variation for AMH was low compared with the inter-cycle variation of other hormones. Between the two groups, there were no differences in the number or quality of embryos obtained or transferred, but the implantation rate was significantly lower in the OC group (24.1 versus 30.1, P 0.03), resulting in an ongoing pregnancy rate of 26.3 compared with 35.7 in the non-OC group (P 0.05). Conclusions: The best predictive model of ovarian response was in the non-OC group and included both AMH and basal FSH determined at the early follicular phase of the stimulation cycle. In the proceeding cycle, AMH alone had sufficient predictive value since it was not affected by inter-cycle variability or OC pretreatment.Clinical trial identifier: NCT00778999. © 2011 The Author. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved.
Bonduelle M.,Universitair Ziekenhuis Brussel |
Oberye J.,Global Clinical Research |
Mannaerts B.,Global Clinical Research |
Devroey P.,Universitair Ziekenhuis Brussel
Human Reproduction | Year: 2010
BackgroundA concern for new compounds in fertility treatment is the possible risk of perinatal complications or birth defects. To demonstrate long-term safety of ganirelix (GnRH antagonist) treatment in controlled ovarian stimulation (COS), follow-up data on pregnancy and neonatal outcome were analysed for 1000 fetuses (≥16 gestational weeks). Methods Obstetrical and neonatal data on 839 pregnancies, Resulting in 969 live born infants after ganirelix treatment were compared with a historical cohort of 753 pregnancies after long GnRH agonist (buserelin) treatment, Resulting in 963 live born infants. All treatment cycles were performed in a single fertility centre. The infants were examined at the Universitair Ziekenhuis Brussel using an identical follow-up protocol. Incidence of major malformations (i.e. causing functional impairment or requiring surgical correction) was the primary end-point and was analysed by logistic regression including treatment, age of mother, IVF method and pregnancy type (singleton/multiple) as independent variables. Result SThere were no relevant differences in maternal characteristics, fertilization method and pregnancy and delivery complications between the ganirelix and historical GnRH agonist groups. There were relatively more multiple pregnancies in the historical GnRH agonist group (31.9) than the ganirelix group (18.7; P < 0.0001). The groups were comparable with respect to pregnancy loss after 16 weeks gestation. The incidence of major congenital malformations in fetuses with gestational age ≥26 weeks was 5.0 in the ganirelix cohort versus 5.4 in the historical GnRH agonist group (odds ratio 0.94, 95 confidence interval, 0.62-1.42). CONCLUSION In terms of neonatal outcome and risk of major malformations, treatment with the GnRH antagonist ganirelix during COS is as safe as traditional GnRH agonists. ClinicalTrials.gov identifier NCT00724789. © The Author 2010.