scholarly journals Pregnancy and neonatal outcomes in fresh and frozen cycles using blastocysts derived from ovarian stimulation with follitropin delta

2021 ◽  
Author(s):  
Jon Havelock ◽  
Anna-Karina Aaris Henningsen ◽  
Bernadette Mannaerts ◽  
Joan-Carles Arce ◽  
Keyword(s):  
Ovarian Stimulation ◽  
Implantation Rate ◽  
Neonatal Outcomes ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Relative Contribution ◽  
Follitropin Alfa ◽  
Start Up ◽  
Comparative Trials

Abstract Purpose To describe the pregnancy and neonatal outcomes using fresh and vitrified/warmed blastocysts obtained from ovarian stimulation with follitropin delta in controlled trials versus follitropin alfa. Methods This investigation evaluated the outcome from 2719 fresh and frozen cycles performed in 1326 IVF/ICSI patients who could start up to three ovarian stimulations in the ESTHER-1 (NCT01956110) and ESTHER-2 (NCT01956123) trials, covering 1012 fresh cycles and 341 frozen cycles with follitropin delta and 1015 fresh cycles and 351 frozen cycles with follitropin alfa. Of the 1326 first cycle patients, 513 continued to cycle 2 and 188 to cycle 3, and 441 patients started frozen cycles after the fresh cycles. Pregnancy follow-up was continued until 4 weeks after birth. Results The overall cumulative take-home baby rate after up to three stimulation cycles was 60.3% with follitropin delta and 60.7% with follitropin alfa (−0.2% [95% CI: −5.4%; 5.0%]), of which the relative contribution was 72.8% from fresh cycles and 27.2% from frozen cycles in each treatment group. Across the fresh cycles, the ongoing implantation rate was 32.1% for follitropin delta and 32.1% for follitropin alfa, while it was 27.6% and 27.8%, respectively, for the frozen cycles. Major congenital anomalies among the live-born neonates up until 4 weeks were reported at an incidence of 1.6% with follitropin delta and 1.8% with follitropin alfa (−0.2% [95% CI: −1.9%; 1.5%]). Conclusions Based on comparative trials, the pregnancy and neonatal outcomes from fresh and frozen cycles provide reassuring data on the efficacy and safety of follitropin delta. Trial registration ClinicalTrials.gov Identifier: NCT01956110 registered on 8 October 2013; NCT01956123 registered on 8 October 2013.

Efficacy and safety of drug-eluting balloon-only strategy (DEB-only) for de novo coronary artery disease: a systematic review and meta-analysis

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
W.Y Zhang ◽  
M.D Zhang ◽  
J.F Tian ◽  
M Zhang ◽  
Y Zhou ◽  
...  
Keyword(s):  
De Novo ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Late Lumen Loss ◽  
Drug Eluting ◽  
Coronary Lesions ◽  
Artery Disease ◽  
Drug Eluting Balloon

Abstract Background Many clinical trials have demonstrated the value of drug-eluting balloon (DEB) for in-stent restenosis. Recently, DEB for de novo lesions has also attracted more attention. There have been promising results of PCI using DEB alone in selected de novo coronary diseases (small vessels, bifurcating lesions, acute myocardial infarction). However, the application of DEB for patients with de novo coronary artery disease remains controversial due to relatively limited evidence. Purpose The purpose of this study was to evaluate the efficacy and safety DEB-only strategy (bail-out stents were allowed when required) compared with other modalities for the treatment of de novo coronary lesions. Methods We searched PubMed, Embase, Web of Science and Cochrane Library Central Register of Controlled Trials (CENTRAL) electronic databases for randomized controlled trials as well as observational studies published up to Jan 22, 2020. Studies which compared DEB-only approach with other PCI strategies for treatment of any type of de novo coronary lesions were identified. The primary outcome was late lumen loss (LLL) during angiographic follow up. The secondary outcomes were major adverse cardiac events (MACE), target lesion revascularisation (TLR) and binary in-segment restenosis. Results Nineteen studies (eleven randomised controlled trials and eight observational studies) with a total of 3,356 patients were included in this meta-analysis. Angiographic observations were obtained at 6 or 9 months and clinical follow-up duration ranged from 6 months to 36 months. Among the overall studies, the results indicated that DEB-only strategy was superior to the control groups for LLL (mean difference (MD) = −0.30mm; 95% confidence interval (CI), −0.41 to −0.19; P<0.001). DEBs were associated with a similar risk of MACE (risk ratio (RR): 0.84, 95% CI: 0.64, 1.11, P=0.22), TLR (RR: 0.79, 95% CI: 0.53, 1.16, P=0.23) and binary restenosis (RR: 0.68, 95% CI: 0.35, 1.31, P=0.25) compared with the control groups. In subgroup analysis, DEB-only strategy showed significantly better outcomes for most endpoints compared to POBA. Compared with DES, there were also significant favorable effects associated with treatment of DEB-only on LLL (MD: −0.14, 95% CI: −0.23, −0.04, P=0.005), while insignificant inter-strategy differences were observed in other endpoints. Vessel diameter did not have a significant influence on the result. Conclusion DEB-only intervention is an effective treatment associated with a significant reduction in late loss late lumen loss compared to other options. The efficacy and safety of DEB alone are comparable to those of DES and superior to POBA for treatment of selected de novo coronary lesions. Additional evidence is still warranted to confirm value of DEB before a widespread clinical utilization can be recommended. Funding Acknowledgement Type of funding source: Public Institution(s). Main funding source(s): Beijing Lab for Cardiovascular Precision Medicine

P–586 Clinical outcome in frozen cycles using cryopreserved blastocysts derived from ovarian stimulation with follitropin delta

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
J Havelock ◽  
J C Arce ◽  
X ESTHER-. an. ESTHER
Keyword(s):  
Clinical Outcome ◽  
Live Birth ◽  
Ovarian Stimulation ◽  
Birth Rate ◽  
Clinical Performance ◽  
Randomised Trial ◽  
Survival Rates ◽  
Implantation Rate ◽  
Live Birth Rate ◽  
Follitropin Alfa

Abstract Study question To compare the live birth rate using frozen-thawed blastocysts obtained from ovarian stimulation with individualised follitropin delta dosing to conventional follitropin alfa dosing. Summary answer The live birth rate in cryo cycles conducted within 1 year after ovarian stimulation was comparable for individualised follitropin delta and conventional follitropin alfa treatment. What is known already It has been demonstrated that the follitropin delta (Rekovelle, Ferring Pharmaceuticals) in an individualised dosing regimen based on anti-Müllerian hormone (AMH) level and body weight is non-inferior to conventional follitropin alfa (Gonal-f, Merck Serono) dosing with respect to ongoing pregnancy and ongoing implantation rates in fresh cycles. The individualised approach also reduced the risk of ovarian hyperstimulation syndrome (OHSS) versus the conventional approach. Furthermore, treatment with follitropin delta and follitropin alfa gave comparable pregnancy rates in repeated fresh cycles. Study design, size, duration Analysis of frozen cycles using blastocysts obtained from a randomised trial comparing follitropin delta versus follitropin alfa in 1,326 IVF/ICSI patients (18–40 years) and a subsequent trial of up to two additional ovarian stimulation cycles. The clinical outcome includes women with cryopreserved blastocysts following ovarian stimulation and who underwent frozen cycles within 1 year after starting stimulation in their last cycle. Participants/materials, setting, methods A total of 917 women had at least one Day 5 blastocyst which was vitrified and stored following up to three ovarian stimulation cycles. A started cryo cycle was defined as warming of a blastocyst. After warming, 1–2 blastocysts were transferred in cryo cycles, using natural cycle or programmed regimens. Treatment differences and 95% confidence intervals (CI) were calculated with adjustment for age strata and accounting for repeated cycles within patient. Main results and the role of chance The proportion of women with frozen blastocysts was similar in the two treatment groups, with 69.5% in the follitropin delta group and 68.8% in the follitropin alfa group. Similar postwarming blastocyst survival rates were observed for the two groups, with 87.4% of the warmed blastocysts proceeding to transfer in the follitropin delta group and 88.8% in the follitropin alfa group. About half of the women (48.1% in each treatment group) with frozen blastocysts underwent at least one frozen cycle with transfer within the 1-year period, with an average of 1.5 cycles per woman in the follitropin delta group and 1.6 cycles per woman in the follitropin alfa group. The ongoing implantation rate was 27.6% in the follitropin delta group and 27.8% in the follitropin alfa group (adjusted difference 0.5% [95% CI: –7.1%; 8.2%]). The live birth rate per started cryo cycle was 32.0% in the follitropin delta group and 31.3% in the follitropin alfa group (adjusted difference 1.2% [95% CI: –6.8%; 9.3%]), while the live birth rate per cryo cycle with transfer was 33.2% and 31.9% (adjusted difference 1.9% [95% CI: –6.2%; 10.0%]), respectively. Limitations, reasons for caution The number of blastocysts to be transferred in the frozen cycles as well as the protocol for endometrial preparation was based on local centre practices. Wider implications of the findings: These findings suggest that the follitropin delta and follitropin alfa dosing regimens are equally effective in terms of live birth rate in frozen replacement cycles and add reassuring information to the clinical performance of cryopreserved blastocysts derived from ovarian stimulation with follitropin delta. Trial registration number NCT01956110, NCT01956123.

Paradise™ Ultrasound Renal Denervation System for the treatment of hypertension

2021 ◽  
Author(s):  
Yu Sato ◽  
Rika Kawakami ◽  
Atsushi Sakamoto ◽  
Anne Cornelissen ◽  
Masayuki Mori ◽  
...  
Keyword(s):  
Renal Denervation ◽  
Arterial Wall ◽  
Treatment Approach ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Novel Treatment ◽  
Treatment Of Hypertension ◽  
The Usa ◽  
Device Approval

Catheter-based renal denervation is a novel treatment approach for patients with hypertension and initial unblinded trials have shown promising results. The Paradise™ Ultrasound Renal Denervation System (ReCor Medical, CA, USA) is an ultrasound-based catheter with a distal balloon that acts as a coolant to protect the renal arterial wall. This device received CE-mark in 2012. Randomized, sham-controlled trials and postmarket studies have shown promising efficacy and safety results. Currently, three additional ongoing randomized, sham-controlled trials are underway in the USA, Europe, Japan and Korea, and the results will be pivotal in device approval in some of these countries. These studies with larger numbers of patients and longer duration of follow-up are needed to further confirm the safety and efficacy of this device.

scholarly journals Efficacy and Safety of Bevacizumab in the Treatment of Pterygium: An Updated Meta-Analysis of Randomized Controlled Trials

2018 ◽  
Vol 2018 ◽  
pp. 1-9 ◽  
Author(s):  
Yi Sun ◽  
Bowen Zhang ◽  
Xiuhua Jia ◽  
Shiqi Ling ◽  
Juan Deng
Keyword(s):  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Complication Rates ◽  
Efficacy And Safety ◽  
Conjunctival Autograft ◽  
Randomized Controlled ◽  
Significant Difference

Purpose. Studies investigating efficacy and safety of bevacizumab in pterygium have increased and reported controversial results. Thus, we updated this meta-analysis to clarify the issue. Methods. Studies were selected through search of the databases Embase, PubMed, Web of Science, and the Cochrane Central Register of Controlled Trials (CENTRAL) from their inception up until June 2017. The pooled risk ratio (RR) and 95% confidence interval (CI) were calculated for recurrence and complication rates by using random effects model. Results. 1045 eyes in 18 randomized controlled trials (RCTs) enrolled. Overall, the pooled estimate showed a statistically significant effect of bevacizumab on the reduction of recurrence (RR 0.74, 95% CI 0.56–0.97, P=0.03). Subgroup analyses presented significant results beneficial to bevacizumab (primary pterygium group, RR 0.53, 95% CI 0.33–0.83, P=0.006; conjunctival autograft group, RR 0.48, 95% CI 0.25–0.91, P=0.02; and follow-up longer than 12 months group, RR 0.36, 95% CI 0.13–0.99, P=0.05). No statistically significant difference was observed in complication rates. Conclusions. Application of bevacizumab showed a statistically significant decrease in recurrence rate following removal of primary pterygia, or in cases with conjunctival autograft, or with follow-up longer than 12 months, while complications were not increased.

scholarly journals A Qualitative Systematic Review of Head-to-Head Randomized Controlled Trials of Oral Analgesics in Neuropathic Pain

2010 ◽  
Vol 15 (3) ◽  
pp. 147-157 ◽  
Author(s):  
C Peter N Watson ◽  
Ian Gilron ◽  
Jana Sawynok
Keyword(s):  
Systematic Review ◽  
Neuropathic Pain ◽  
Randomized Controlled Trials ◽  
Controlled Trials ◽  
Relative Efficacy ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Jadad Scale ◽  
Qualitative Systematic Review ◽  
Comparative Trials

BACKGROUND: Neuropathic pain (NP) encompasses many difficult-to-treat disorders. There are few head-to-head, comparative, randomized controlled trials (RCTs) of drugs for NP in different analgesic categories, or of different drugs within a category, despite many placebo-controlled RCTs for individual agents. Well-designed head-to-head comparative trials are an effective way to determine the relative efficacy and safety of a new drug.OBJECTIVE: To perform a systematic review of head-to-head RCTs of oral analgesics in NP.METHODS: A systematic review of RCTs involving NP patients was performed, of which head-to-head comparative trials were selected. Reference lists from published systematic reviews were searched. These studies were rated according to the Jadad scale for quality.RESULTS AND CONCLUSIONS: Twenty-seven such trials were identified. Seventeen were comparisons of different analgesics, and 10 were of different drugs within an analgesic class. Important information was obtained about the relative efficacy and safety of drugs in different categories and within a category. Some significant differences between active treatments were reported. Trial inadequacies were identified. More and improved head-to-head RCTs are needed to inform clinical choices.

Comparative Efficacy and Safety of Nonsurgical Treatment Options for Enthesopathy of the Extensor Carpi Radialis Brevis: A Systematic Review and Meta-analysis of Randomized Placebo-Controlled Trials

2018 ◽  
Vol 47 (12) ◽  
pp. 3019-3029 ◽  
Author(s):  
Jayson Lian ◽  
Amin Mohamadi ◽  
Jimmy J. Chan ◽  
Phillip Hanna ◽  
David Hemmati ◽  
...  
Keyword(s):  
Pain Relief ◽  
Meta Analysis ◽  
Treatment Options ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Short Term ◽  
Long Term Follow Up ◽  
Extensor Carpi Radialis

Background: Numerous treatment options have been proposed for enthesopathy of the extensor carpi radialis brevis (eECRB). Purpose: To (1) compare the efficacy and safety of nonsurgical treatment options for eECRB described in randomized placebo-controlled trials at short-term, midterm, and long-term follow-up and (2) evaluate outcomes in patients receiving placebo. Study Design: Systematic review and meta-analysis. Methods: Following PRISMA guidelines, 4 electronic databases were searched for randomized placebo-controlled trials for eECRB. Studies reporting visual analog scale (VAS) for pain scores and/or grip strength were included. Random- or fixed-effects meta-analysis was employed to compare treatments with at least 2 eligible studies using the standardized mean difference and odds ratio. The study protocol was registered at PROSPERO (ID: CRD42018075009). Results: Thirty-six randomized placebo-controlled trials, evaluating 11 different treatment modalities, with a total of 2746 patients were included. At short-term follow-up, only local corticosteroid injection improved pain; however, it was associated with pain worse than placebo at long-term follow-up. At midterm follow-up, laser therapy and local botulinum toxin injection improved pain. At long-term follow-up, extracorporeal shock wave therapy provided pain relief. With regard to grip strength, only laser therapy showed better outcomes in comparison with placebo. While there was no difference among various treatments in the odds ratio of an adverse event, they all increased adverse events compared with placebo. In placebo-receiving patients, a sharp increase in the percentage of patients reporting mild pain or less was observed from 2% at short-term follow-up to 92% at midterm follow-up. Conclusion: Most patients experienced pain resolution after receiving placebo within 4 weeks of follow-up. At best, all treatments provided only small pain relief while increasing the odds of adverse events. Therefore, if clinicians are inclined to provide a treatment for particular patients, they may consider a pain relief regimen for the first 4 weeks of symptom duration. Patient-specific factors should be considered when deciding on treatment or watchful waiting.

scholarly journals Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials

2013 ◽  
Vol 29 (suppl 1) ◽  
pp. s17-s31 ◽  
Author(s):  
Cassyano Januário Correr ◽  
Inajara Rotta ◽  
Thaís de Souza Teles ◽  
Rangel Ray Godoy ◽  
Bruno Salgado Riveros ◽  
...  
Keyword(s):  
Adverse Events ◽  
Meta Analysis ◽  
Biological Agents ◽  
Severe Psoriasis ◽  
Biological Agent ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Short Term ◽  
Serious Adverse Events

We conducted a systematic review and metaanalysis of randomized placebo-controlled trials in moderate-to-severe psoriasis treated with biological agents, with a follow-up of 10-14 weeks. Overall, 41 studies, with mean Jadad score of 4.4, and 15,586 patients were included. For the efficacy outcomes PASI 50, 75 and 90 our findings are not conclusive to point what biological agent has the greatest response in short term follow-up. There were no statistical differences between placebo and biologics for the occurrence of infections and serious adverse events. Ustekinumab 45mg showed lower withdrawal due to adverse events compared with the placebo. Based on data available up to now, it is not possible to determine which biological agent is the best for PASI 50, 75 or 90 after 10-14 weeks of treatment. At the same follow-up, overall safety seems to be the same for all biological agents and Ustekinumab 45mg the most well tolerated drug. To better understand efficacy and safety, indirect meta-analysis comparing drug-to-drug is required since randomized placebo-controlled trials may not be feasible.

scholarly journals Comparing a biosimilar follitropin alfa (Cinnal-f®) with Gonal-f® in women undergoing ovarian stimulation: An RCT

2021 ◽  
Author(s):  
Batool Hossein Rashidi ◽  
Khashayar Sayyari ◽  
Ramin Heshmat ◽  
Saeid Amanpour ◽  
Ensieh Shahrokh Tehraninejad ◽  
...  
Keyword(s):  
Intracytoplasmic Sperm Injection ◽  
Ovarian Stimulation ◽  
Recombinant Dna ◽  
Controlled Trial ◽  
Follicle Stimulating Hormone ◽  
Efficacy And Safety ◽  
Follitropin Alfa ◽  
Significant Difference ◽  
Secondary Outcomes ◽  
Stimulating Hormone

Background: Advances in recombinant DNA technology led to the development of recombinant follitropin alfa. Recombinant human follicle-stimulating hormone products are used to stimulate follicular maturation. Objective: To compare the efficacy and safety of a biosimilar-candidate recombinant human follicle-stimulating hormone (Cinnal-f® ; CinnaGen, Iran) with the reference product (Gonal-f® ; Merck Serono, Germany) in women undergoing ovarian stimulation for intracytoplasmic sperm injection (ICSI). Materials and Methods: In this randomized controlled trial, a total sample size of 200 women (age < 35 yr, candidate for ICSI) was calculated. Participants began a pituitary downregulation protocol with buserelin. They received 150 IU daily of either Cinnal-f® or Gonal-f® from the second day of their cycle. The primary outcome of the study was the percentage of metaphase II (MII) oocytes. The secondary outcomes included the number and quality of oocytes retrieved, duration of stimulation, fertilization rate, embryo quality, the number of clinical and ongoing pregnancies, and the incidence of ovarian hyperstimulation syndrome (as an important safety marker). Results: A total of 208 women were enrolled, of whom, 200 completed the study period. Ovarian stimulation with Cinnal-f® resulted in a comparable percentage of MII oocytes as with Gonal-f® (78.64% vs 80.02%, respectively; p = 0.81). No statistically significant difference was seen in the secondary outcomes between the groups. Conclusion: Cinnal-f® proved non-inferior to Gonal-f® , based on the percentage of MII oocytes in women aged < 35 yr undergoing ICSI. Our findings confirm that the efficacy and safety profiles of Cinnal-f® and Gonal-f® are similar. Key words: Follitropin alfa, Biosimilar, Efficacy, Safety, Intracytoplasmic sperm injection.

Sign in / Sign up

Export Citation Format

Share Document