Suprefact (buserelin acetate) / Sanofi - LARVOL DELTA

Reproductive performance of yearling Bos indicus heifers submitted to programs for induction of ovulation prior to a timed-artificial insemination protocol. (PubMed, Theriogenology) - "On Day -24, a total of 2000 heifers (12.3 ± 0.03 mo old; 224.9 ± 0.7 kg of body weight [BW]), managed in a feedlot system, were randomly assigned to one of two ovulation induction protocols: 1) P4+E2 (n = 963): an intravaginal progesterone (P4) device (0.5 g) was inserted on Day -24 and removed on Day -12, when heifers received 0.5 mg of estradiol (E2) cypionate (EC); 2) iP4 (n = 1037): administration of 150 mg of long-acting injectable P4 on Day -24...On Day 9, 8.4 μg of buserelin acetate was administered, and TAI was performed...Age, BW, and ADG positively influenced the presence of CL, with BW and ADG significantly improving fertility outcomes. These findings emphasize the importance of nutritional management to accelerate body development and optimize reproductive performance in young heifers."

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Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial (clinicaltrials.gov) - P3 | N=2050 | Recruiting | Sponsor: NRG Oncology | Trial completion date: Apr 2037 ➔ Nov 2026 | Trial primary completion date: Apr 2032 ➔ Nov 2026

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

Retinol and cholecalciferol affect buserelin-induced estrous in anestrous mares. (PubMed, Trop Anim Health Prod) - "Supplementing with retinol and cholecalciferol improved the rate of buserelin-induced estrous in anestrous mares. Further research is necessary to determine underlying mechanisms."

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Ultrasonic Evaluation of the Corpus Luteum in Alpacas With Embryo Removal on Day 9 Post-Mating. (PubMed, Reprod Domest Anim) - "For this purpose, 12 female alpacas with follicles ≥ 7 mm were mated with fertile males and treated with 0.0084 mg of buserelin acetate (Day 0)...In conclusion, the CL characteristics in alpacas with embryo removal changed drastically after Day 9, presenting progressive regression in size and blood flow from Day 11 to 13. These results might indicate that the presence of an embryo on Day 9 is necessary to trigger the signal that prevents luteolysis in this species."

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Fertility programs for lactating dairy cows: a novel Presynch + Timed AI program (Double E-Synch) produces similar ovarian dynamics, synchronization, and fertility as Double-Ovsynch. (PubMed, J Dairy Sci) - "On d -17 (34 ± 3 d in milk), the Ovs presynch was initiated with 10 µg of buserelin acetate (GnRH), and cows received 0.5 mg of cloprostenol sodium (PGF) on d -10, and 10 µg of GnRH on d -7...In conclusion, the study validated 2 presynchronization strategies and 2 TAI protocols, establishing 4 possible fertility programs, all of them producing well-controlled ovarian dynamics, excellent synchronization, and high fertility. Moreover, Double-Ovsynch and Double E-Synch both produced similar results, despite differences in pharmacological bases."

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Reproductive outcomes of lactating dairy cows submitted to first timed-artificial insemination protocols with different strategies to induce final ovulation. (PubMed, J Dairy Sci) - "A total of 909 lactating dairy cows from 6 dairy herds initiated a presynchronization protocol on d -15 with an intravaginal progesterone (P4) implant and 7 d later (d -8) were treated with 1.0 mg of estradiol cypionate (EC) and 0.530 mg of cloprostenol sodium (PGF), simultaneously with the P4 implant removal. On d 0, the protocol for synchronization of ovulation was initiated with 16.8 µg of buserelin acetate (GnRH) and insertion of a 2.0 g P4 implant, followed by a treatment with 0.530 mg of PGF on d 6, and a second PGF on d 7, concomitant with the P4 implant withdrawal...Fertility was greater in cows with CL at the time of the first PGF treatment than in cows without CL (45.9 vs. 17.7%). In summary, the strategies to induce final ovulation resulted in similar fertility despite the different physiological responses such as expression of estrus, but further research is needed to definitively confirm the relationship between lack of EC and increased pregnancy loss."

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Quality by design (QbD) based development and validation of RP-HPLC method for buserelin acetate in polymeric nanoparticles: Release study. (PubMed, Heliyon) - "The stability of the stock solution was assessed over the 8th day and found to be stable for a longer duration of time. The method has been successfully applied for the analysis of BA in polymeric nanoparticles."

Journal • Breast Cancer • Oncology • Solid Tumor

Use of Injectable Progesterone as a Pre-Synchronisation Strategy in a Timed Artificial Insemination Protocol Based on Gonadotropin-Releasing Hormone and Progesterone in Bos indicus Beef Cows in Anoestrous. (PubMed, Reprod Domest Anim) - "On D0, the ovarian assessment was repeated, and TAI protocol was initiated in all animals, with the insertion of an intravaginal P4 device and administration of 10.5 μg of buserelin acetate (gonadotropin-releasing hormone-GnRH). The pregnancy rate was similar (p = 0.64) between groups and was not influenced by the CL rate on D7 (p = 0.48), oestrous expression (p = 0.20) or their interaction (p > 0.1). Pre-synchronisation effectively increased the proportion of cows with CL on D7 without altering the diameter of the largest follicle, oestrous expression or pregnancy rate in anoestrous cows treated with a GnRH/P4-based TAI protocol."

Clinical • Journal

Buserelin Promotes the Differentiation and Function of Macrophage-Colony-Stimulating Factor-Producing T Helper Cells. (PubMed, Immunol Invest) - "Rat CPP was induced by danazol injection followed by buserelin treatment. Buserelin enhances the differentiation and function of pro-inflammatory ThGM cells, thus increasing the risk of autoimmune or inflammatory disorders. Therefore, it is necessary to monitor ThGM cells in buserelin-treated children to prevent latent immune dysregulation."

Journal • Endocrine Disorders • Immunology • Inflammation • NFATC1

Mechanistic Model for Drug Release from PLGA-Based Biodegradable Implants for In Vitro Release Testing: Development and Validation. (PubMed, ACS Appl Bio Mater) - "The model has been validated using in vitro release data obtained from implants of four drugs (buserelin, afamelanotide, brimonidine, and nafarelin). The model presented in this manuscript provides valuable insights into the kinetics and mechanism of drug release from PLGA-based solid implants and has demonstrated the potential for optimizing formulation design. The in vitro release model, coupled with physiologically based pharmacokinetic (PBPK) modeling, can predict the in vivo performance of implants and can be used to support bioequivalence studies in a drug development program."

Journal • Preclinical

Potency evaluation of different GNRH analogues on ovulation induction and reproductive performance of doe rabbit. (PubMed, Reprod Domest Anim) - "Four experimental groups were used, females from the Control group were induced to ovulate with an intramuscular administration of 1 μg of buserelin, while in the other three groups females received an intravaginal administration of 3.5 μg of buserelin (BUS), deslorelin (DES) or fertirelin (FER) within the seminal dose. Results showed that the ovulation frequency was similar in all groups studied. A concentration of 3.5 μg of the different GnRH analogues tested in this study showed similar potency in inducing ovulation in non-lactating females, yielding comparable results in terms of pregnancy rate at birth and prolificacy."

Journal • Preclinical

Effect of the Application of PGF2α Associated With Ovulation Induction in a Fixed-Time Superovulation Programme for Precocious Nellore Heifers. (PubMed, Reprod Domest Anim) - "On day 0 (D0), all animals received intravaginal insertion of a progesterone (P4) device along with intramuscular administration of 2 mg of oestradiol benzoate, plus 200 IU of follicle-stimulating hormone in decreasing doses, with 12-h intervals between D4 and D7, in addition to 150 μg of D-cloprostenol on D6 and device removal on D7. On D8, the donors received 10.5 μg of buserelin acetate and the treatment group received 300 μg of D-cloprostenol/PGF2α...There was no difference in the total number of embryos between the control and treatment groups (10.40 ± 1.52 vs. 9.60 ± 1.36; p = 0.63) or viable embryos (6.30 ± 1.22 vs. 4.30 ± 0.71). For precocious indicus heifers, treatment with PGF2α in association with GnRH did not affect embryo production in the fixed-time SOV protocol."

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Hyperandrogenic eumenorrheic NON-PCOS women versus women with PCOS after the GnRH-agonist stimulation test preceded by suppression of adrenal steroidogenesis with dexamethasone. (PubMed, J Clin Transl Endocrinol) - "It has previously been shown that around half of PCOS women exhibit a hyper-response of serum 17-hydroxy-progesterone (17-OHP) to the stimulation by GnRH-agonists, also indicated as functional ovarian hyperandrogenism (FOH)...Interestingly, treatment of women with PCOS with Dex suppression and GnRH-agonist stimulation (buserelin) highlighted the possible existence of two clusters of patients: hyper-responders (HR) and normal responders (NR)...Moreover, within women with PCOS, the HR subgroup has higher insulin levels compared to the NR subgroup, when OGTT is performed. The alteration of the glucose-insulin balance and elevation of circulating androgens were more pronounced in PCOS, thus indicating that [i.] metabolic alterations might be crucial in the onset of PCOS itself and, [ii] EuHyperA might represent a milder form of PCOS."

Journal • Polycystic Ovary Syndrome • CYP17A1

Effect of repeated low doses of gonadotropin-releasing hormone on the secretion of luteinizing hormone and follicle-stimulating hormone, and ovarian function in dairy cows suffering from anovulation type I. (PubMed, Anim Reprod Sci) - "Concentrations of progesterone, FSH, and LH in the blood were analysed using radioimmunoassay (RIA). Ovulation occurred in 4 of the 5 treated cows, but only in 1 of the control cows in the 40 days after treatment. In conclusion, repeated low doses of GnRH analogue buserelin once a day for 5 days may increase the concentration of FSH and LH in dairy cows with anovulation type I."

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Premenstrual Dysphoric Disorder: systematic review of alternative treatments (NAMS 2024) - "There was no significant effect observed for myo-inositol, clonidine, magnesium sulfate, quetiapine combined with antidepressants, chromium polynicotinate combined with sertraline, light therapy, or auriculotherapy. However, there was a significant effect observed for massage (one study, high risk of bias), cognitive-behavioral therapy (CBT) (two studies, elevated risk of bias), buserelin (one study, low risk of bias), dutasteride (one study, low risk of bias), acupuncture (one study, elevated risk of bias), sepranolone (one study, low risk of bias), phosphatidylserine (one study, low risk of bias), emotion-focused group therapy (one study, high risk of bias), and homeopathic treatment (one study without blinding and placebo control, high risk of bias). Vitex agnus castus had a similar effect to fluoxetine (one study, some risk of bias)... CBT and physical exercises appear to be effective as complementary treatments for PMDD, but the literature lacks robust evidence...."

Review • CNS Disorders • Depression • Gynecology

Buserelin Acetate Added to Boar Semen Enhances Litter Size in Gilts in Tropical Environments. (PubMed, Animals (Basel)) - "The gilts' estrus was synchronized with oral altrenogest supplementation at a dosage of 20 mg/day for 18 days. In conclusion, adding a GnRH agonist to boar semen appears to enhance the litter size of gilts. Further research should focus on understanding the underlying mechanisms and determining the optimal dose and timing for GnRH agonist supplementation."

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Evaluation of the efficiency of estrus synchronization protocols combined with natural service and ultrasonography on ewe reproductive performance during non-breeding season. (PubMed, Iran J Vet Res) - "Subsequently, NP4-GnRH and NP4-eCG groups received 8 µg of buserelin acetate or 200 IU of eCG intramuscularly, respectively on day 12 whereas NP4-Insulin group received insulin 0.2 IU/kg body weight subcutaneously for three consecutive days started on the day of sponge removal. The single and multiple birth rates were 71.41, 36.36 and 60.0%, and 28.57, 63.64, and 40.0% whereas prolificacy was 128.57, 190.91, and 140.00%, respectively in NP4-GnRH, NP4-eCG, and NP4-Insulin groups. In conclusion, the estrus synchronization protocol including intravaginal progesterone sponge and eCG was found to be more effective under field conditions."

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Is it possible to replace eCG by GnRH in the hormonal protocol for timed artificial insemination in ewes during the breeding season? (PubMed, Domest Anim Endocrinol) - "1, at IVD removal, ewes (n = 29) were allocated to three groups: eCG (200 IU at IVD removal; n = 10); eCG+GnRH (200 IU eCG at IVD removal and 4 µg of buserelin 36 h later; n = 10); or GnRH (buserelin 36 h after IVD removal; n = 9)...3, pregnancy rate was significantly lower (P = 0.02) in GnRH (22.5 %; 9/40) compared to eCG (46.7 %; 21/45). The results indicate that, although ovulation and luteal function were not altered after eCG, eCG+GnRH or GnRH treatment, GnRH alone before TAI cannot be used to replace eCG treatment during the breeding season."

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EUROAPI - Availability of 2024 Half-Year Financial Report (GlobeNewswire) - "Net sales by product category: Large molecules increased by 67.9% to €58.8 million, driven by the stock clearance of Buserelin, and the ramp-up of a commercial phase contract in Large Molecules with Sanofi."

Sales • Endometriosis • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Exogenous FSH/LH modulates TGF beta signaling genes in granulosa cells of Simmental heifers without affecting IVP results. (PubMed, Theriogenology) - "Follicular waves were synchronized using 0.5 mg cloprostenol on Day 0, followed by 10 μg buserelin on Day 2...Our results demonstrated no benefit of this FSH stimulation protocol on IVP results in Simmental heifers. Further, our results suggest that the effects of FSH on bovine oocytes during acquisition of developmental competence may be mediated through BMP, but do not involve the regulation of transcriptional availability of GDF9, providing new insights into possible paracrine effects of the oocyte on granulosa cells."

Journal • BMPR1A • HIF1A • TGFB1

Treatment alternatives to induce follicular wave emergence for timed-AI in lactating dairy Cows. (PubMed, Theriogenology) - "In Experiment 1, lactating, primiparous Holstein cows (n = 36) received a P4 releasing device (Day 0) and were allocated at random to one of the following three treatment groups: Group EB received 2 mg E2 benzoate (EB) intramuscularly (i.m.), Group EB + GnRH received 2 mg EB+20 μg buserelin (GnRH) i.m., or Group EB + P4 received 2 mg EB + 100 mg of injectable P4 (iP4) in oil i.m. All cows received 0.150 mg D-Cloprostenol on Days 7 and 8 followed by P4 device removal, 400 IU eCG and 1 mg ECP on Day 8...Cows in the EB + GnRH group had greater P/AI (57.4 %, P < 0.01) than those in the EB (44.6 %) or EB + P4 (45.7 %) groups. In conclusion, the administration of GnRH, but not iP4, on the day of insertion of a P4 device improves P/AI in lactating dairy cows synchronized for TAI with an estradiol/P4-based protocol."

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Effect of hormonal treatment on artificial propagation, spawning performance and embryonic development of striped snakehead Channa striata (Bloch, 1793). (PubMed, Anim Reprod Sci) - "However, T3 exhibited best performance regarding spawning, fertilization and hatching rate which were significantly higher than other two treatments.The current study revealed that spawning induction using carp pituitary extract and Buserelin is effective and might be useful for artificial breeding of Channa striata. Regarding to dose application i.e. 80 mg kg-1 of CPE and 0.80 µg kg-1 of Buserelin may be successfully applied to ovulation stimulation of Channa striata."

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DOUBLE TRIGGER IN COS: EMBRYO QUALITY AND SUCCESS RATE (ASPIRE 2024) - "The pregnancy rate obtained in this study was 31.8% vs. 29.5%. Conclusions There are no significant differences were found in embryo quality and pregnancy success rate in patients who received double trigger therapy (Ovidrel and Buserelin) compared to single therapy (Ovidrel)."

Gynecology • Infertility • Sexual Disorders

Prostaglandin F2α treatment does not hasten ovulation in weaned sows. (PubMed, Domest Anim Endocrinol) - "In experiment II, weaned sows that did not express estrus signs until 72 h after weaning (0 h) were assigned to: no hormone (Control; n = 45); 10 µg buserelin acetate IM at 0 h (Buserelin; n = 43); 0.5 mg PGF IM at 34 h and 36 h (PGF; n = 44); or 10 µg buserelin acetate IM at 0 h plus 0.5 mg PGF IM at 34 h and 36 h (Buserelin + PGF; n = 45)...Treatments did not affect total number of piglets born in both experiments (P > 0.05). In conclusion, PGF did not hasten ovulation timing or affect litter size in weaned sows."

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Changes on corpus luteum structure and progesterone synthesis pathway after hCG or GnRH treatment during the early luteal phase in sheep. (PubMed, Anim Reprod Sci) - "Sixty-four ewes were assigned to three groups receiving: 300 IU of hCG (hCG) or 4 µg Buserelin (GnRH) or 1 mL of saline solution (Control) on Day (d) 4 post artificial insemination (FTAI). In conclusion, administration of hCG has a notably impact on acc-CL development and the expression of steroidogenic enzymes compared to GnRH treatment in ewes. This leads to elevated P4 concentration and improved luteal function."

Journal • HSD3B1 • STAR