Corifollitropin alfa 100micrograms/0.5ml solution for injection pre-filled syringes

Background: Corifollitropin alfa (CFA) is a long-acting recombinant follicle-stimulating hormone (rFSH) used for controlled ovarian stimulation (COS). Several studies analyzing the clinical efficacy and safety of CFA compared to daily rFSH during COS have been carried out. The present study offers a meta-analysis of the randomized controlled trials (RCTs) on this topic. Methods: A computerized search of the published literature was carried out using PubMed, MEDLINE, Science direct and Google Scholar databases. The comparison between CFA and daily rFSH treatments during COS were investigated only in RCTs. The primary endpoint of the study is represented by the number of total oocytes retrieved at ovum pick-up. The studies included in the analysis were pooled together in order to estimate the log odds ratio (OR) or the mean difference (MD) along with the corresponding 95% confidence intervals (CI) by using a random effects model. The heterogeneity between the studies was evaluated with the Higgins and Chi-square tests. Results: The study examined a total of twelve RCTs published from 2004 to date and included a total of 4980 patients, with 2664 receiving CFA and 2316 patients receiving daily rFSH for COS. Women treated with CFA had higher number of total oocytes retrieved at ovum pick-up (MD 0.91, 95% CI [0.34, 1.49], p = 0.001), and higher number of metaphase II (MII) oocytes (MD 1.00, 95% CI [0.37, 1.62], p = 0.002) compared to those receiving daily rFSH. There were no significant differences between the two study groups regarding the other outcomes analyzed. The subgroup analysis performed comparing “normal” versus “poor” responders revealed that normal responders receiving CFA showed an higher cancellation rate, with respect to those receiving rFSH. Conclusions: This study shows that COS with CFA results in a higher number of oocytes retrieved at ovum pick-up in comparison with daily rFSH.

Abstract licence: CC BY

The present study compares two protocols for ovarian controlled stimulation in terms of number of cumulus-oocyte complexes and metaphase II oocytes. We employed a single injection of 150mcg of corifollitropin alfa after a 7-day oral contraceptive pill-free interval for TAIL group and a conventional administration of corifollitropin alfa after a 5-day OCP-free interval with additional rFSH from 8th of ovarian controlled stimulation. Prospective, randomized, comparative, non-inferiority, opened and controlled trial carried out in 180 oocyte donors 31 were excluded, 81 were randomized to the control group and 68 to the TAIL group. No differences were found in the number of follicles larger than 14 and 17 mm at triggering day. However, a lower number of cumulus-oocyte complexes and metaphase II oocytes were obtained in TAIL group compared to the control group, expressed as median (interquartile range): 10.5 (5.5–19) vs. 14 [11–21] and 9 (4–13) vs. 12 (9–17) respectively. Additionally, the incidence of failed retrieval or metaphase II oocytes = 0 was higher in TAIL group 7(10.3%) vs. 1(1.2%) p = 0.024. The use of a single injection of corifollitropin alfa after a 7-day oral contraceptive pill-free interval in oocyte donors resulted in a lower number of cumulus-oocyte complexes and metaphase II oocytes. No additional rFSH was administered in this group. Clinical Trial Registration: https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-001343-44/results .

Abstract licence: CC BY

Background & Aims: Approximately 10% of patients have a sub-optimal response to controlled ovarian stimulation. Many different protocols for superovulation have been developed for this group of patients but the optimal approach for “poor responder” patients is yet to be determined. Use of corifollitropin alfa (Elonva) in a flare (EF) protocol is a novel approach to ovarian stimulation for predicted poor responder patients. We hypothesised that the unique pharmacokinetic and pharmacodynamic profiles of corifollitropin alfa would maximise FSH exposure and follicular recruitment in the critical early follicular phase due to the initial suprathreshold release of bioactive FSH in the initial 2-3 days of exposure to Elonva, in combination with the ‘flare’ of endogenous FSH release. Method: Twenty-one women aged 31-41 were identified as predicted poor responder patients according to the Poseidon criteria. Each participant was randomised to treatment with Elonva/Synarel flare or Elonva/Orgalutran antagonist. Serum FSH and E2 were measured daily for five days following injection of Elonva. The study was approved by the Southeastern Sydney HREC. Results: Serum FSH concentrations were significantly higher at each time point in the EF group when compared with the antagonist group (p=0.022). Peak FSH two days after injection of Elonva, was also significantly higher 27 vs 11 IU/L. Serum E2 concentrations were also significantly higher in the EF group at each time point (p=0.039). On day seven of stimulation, E2 concentrations were 3000 vs 1850 pmol/L. Conclusion: The corifollitropin alfa agonist flare protocol produces significantly higher FSH and E2 concentrations than a standard corifollitropin alfa antagonist protocol for projected poor responder patients, with reduced patient burden for a group who may need multiple ovarian stimulation cycles to achieve a pregnancy. A larger RCT is required to study embryology and pregnancy outcomes, costs and patient burden.

Abstract licence: CC BY-NC-ND

We aimed to assess the impact of the timing of ovarian stimulation initiation on the number of oocytes retrieved in a progestin-primed ovarian stimulation (PPOS) protocol for oocyte donors. A total of 110 oocyte donors were randomized in a multicenter, open-label, pilot randomized controlled trial conducted across four centers in France. Of these, 102 donors completed ovarian stimulation and underwent oocyte retrieval. Donors were assigned to start stimulation with corifollitropin alfa and oral desogestrel during one of five menstrual cycle phases: early follicular (EFP, Days 1–3), mid-follicular (MFP, Days 4–7), late follicular (LFP, Days 8–11), ovulatory (OP, Days 12–15), or luteal (LP, Days 16–30). Final oocyte maturation was triggered with triptorelin acetate. The primary endpoint was the total number of oocytes retrieved, with secondary outcomes including mature oocytes, premature LH surge, and ovarian hyperstimulation syndrome (OHSS). The median age of donors was 33 years, with a mean BMI of 23.4 kg/m². The median number of retrieved oocytes was 11.5, with no significant differences between groups (p = 0.314). The median number of mature oocytes was 10, with no significant differences across groups. Given the limited statistical power inherent to pilot studies, an additional non-inferiority study was conducted. This subsequent analysis confirmed that the number of oocytes retrieved in the less previously studied and more challenging groups — the late follicular and ovulatory phases — was non-inferior to that observed in the reference group, defined as the early follicular phase. One donor in the mid-follicular phase had a premature LH surge (0.98%), and four cases of mild OHSS were reported (3.9%). According to this pilot study, initiating PPOS with corifollitropin alfa at any phase of the menstrual cycle resulted in similar oocyte retrieval outcomes. This flexible approach is safe, effective, and offers potential benefits for donor management, patient convenience, and clinical workflow. Larger, adequately powered studies are required to validate these preliminary findings. ClinicalTrials.gov Identifier: NCT03895099. Date of registration: March 28, 2019. First participant enrolled: September 4, 2020.

Abstract licence: CC BY-NC-ND

Reproductive medicine is actively developing, and new methods, drugs, and protocols are being developed and introduced for the treatment of infertility. Assisted reproductive technologies (ART) are the most effective methods. In ART protocols, ovarian stimulation (OS) is based on gonadotropin use. The choice of the starting dose of gonadotropin is a critical factor in the successful OS and the effectiveness of ART programs. The article describes the development history of gonadotropins and provides current data on their use in ART programs. The use of biosimilars of follitropin alfa in OS is discussed, and the effectiveness of its Russian biosimilar is also addressed. TRANSLATE with x English Arabic Hebrew Polish Bulgarian Hindi Portuguese Catalan Hmong Daw Romanian Chinese Simplified Hungarian Russian Chinese Traditional Indonesian Slovak Czech Italian Slovenian Danish Japanese Spanish Dutch Klingon Swedish English Korean Thai Estonian Latvian Turkish Finnish Lithuanian Ukrainian French Malay Urdu German Maltese Vietnamese Greek Norwegian Welsh Haitian Creole Persian TRANSLATE with COPY THE URL BELOW Back EMBED THE SNIPPET BELOW IN YOUR SITE Enable collaborative features and customize widget: Bing Webmaster Portal Back

Abstract licence: CC BY