purified human menopausal gonadotropin / Generic mfg. - LARVOL DELTA

Impact of gonadotropin selection on risk of ovarian hyperstimulation syndrome in predicted high responders: a Menopur in Gonadotropin-releasing hormone Antagonist Single Embryo Transfer-High Responder trial analysis. (PubMed, F S Rep) - "To evaluate the risk of ovarian hyperstimulation syndrome (OHSS) with highly purified human menopausal gonadotropin (HP-hMG) or recombinant follicle-stimulating hormone (rFSH) for controlled ovarian stimulation in patients predicted to be high responders...Holding the number of oocytes constant, the odds of early OHSS in HP-hMG-treated subjects was 0.46 times (95% CI: 0.26, 0.82) that in rFSH-treated subjects. In predicted high-responder patients, HP-hMG stimulation was associated with significantly diminished OHSS rates compared with rFSH, adjusted for oocyte yield."

Journal • Infertility • Sexual Disorders

Clinical Efficacy and Safety of Two Highly Purified Human Menopausal Gonadotropins (Gynogen HP vs. Menopur) in Women Undergoing In-Vitro Fertilization. (PubMed, Reprod Fertil) - "Gynogen HP is non-inferior and therapeutically equivalent to Menopur in terms of the number of oocytes retrieval, with a comparable safety profile. These results support the use of Gynogen HP for COS in women undergoing IVF as a part of assisted reproduction techniques."

Journal • Preclinical • Gynecology

Gonadotropins for ovulation induction in women with polycystic ovary syndrome. (PubMed, Cochrane Database Syst Rev) - "There may be little or no difference in live birth, multiple pregnancy, clinical pregnancy, or miscarriage rates between rFSH and uFSH in women with PCOS. For HMG versus uFSH, we are uncertain whether one or the other improves or lowers rates of live birth, multiple pregnancy, clinical pregnancy, or miscarriage. We are uncertain whether any of the interventions reduce ectopic pregnancy or the incidence of OHSS. In women with clomiphene citrate failure, gonadotropins (FSH) probably result in more live births and clinical pregnancies than continued clomiphene citrate without increasing multiple pregnancies. Gonadotropins may increase the miscarriage rate per woman. We are uncertain if gonadotropins reduce ectopic pregnancy. None of the women developed OHSS."

Clinical • Journal • Review • Gynecology • Infertility • Polycystic Ovary Syndrome • Sexual Disorders

Comparing highly purified human menopausal gonadotropin and recombinant follicle stimulating hormone in poor ovarian reserve patients undergoing intracytoplasmic sperm injection. (PubMed, Ceska Gynekol) - "Neither hp-hMG nor rFSH showed superiority in patients with POR, indicating similar effectiveness in this population."

Clinical • Journal • Retrospective data • Gynecology

FOLLITROPIN DELTA (REKOVELLE®) IN GROUP 3 AND 4 POSEIDON PATIENTS UNDERGOING IVF/ICSI FOR IN VITRO FERTILIZATION : IS ANTAGONIST PROTOCOL THE BEST? (ASRM 2024) - "SUPPORT no OBJECTIVE Our aim is to evaluate, in IVF/ICSI for women with poor ovarian reserve, in both antagonist and agonist luteal phases gonadotropin-releasing hormone protocols, the stimulation parameters with a controlled ovarian stimulation with follitropin delta, mixed or not with highly purified human menopausal gonadotropin HP-hMG. Luteal agonist protocol may be used for Groups 3 and 4 POSEIDON patients without any statistical difference in terms of pregnancy rate. Nevertheless, Antagonist mixed protocol seems better in this population."

Preclinical • Gynecology

Comparison of highly purified human menopausal gonadotropin and recombinant follicle stimulating hormone use in patients undergoing in vitro fertilization with progestin-primed ovarian stimulation protocol: a single center retrospective analysis. (PubMed, Arch Gynecol Obstet) - "In this study, it is demonstrated that stimulation of oocytes with either rFSH or hMG in the PPOS protocol, which has been added to IVF treatment protocols in recent years, had no statistical difference regarding mature oocyte numbers and live birth rates between the two groups. These results are consistent with the previous literature which compared rFSH and hMG in GnRH agonist and antagonist protocols."

Journal • Preclinical • Retrospective data • Gynecology

Analytical Investigation of the Profile of Human Chorionic Gonadotropin in Highly Purified Human Menopausal Gonadotrophin Preparations. (PubMed, Int J Mol Sci) - "Highly purified human menopausal gonadotropin (HP-hMG [Menopur®, Ferring Pharmaceuticals, Saint-Prex, Switzerland]) contains a 1:1 ratio of follicle-stimulating hormone (FSH) and luteinizing hormone (LH)...Brevactid® (urinary hCG; Ferring Pharmaceuticals, Saint-Prex, Switzerland) and Ovidrel® (recombinant hCG; Merck KGaA, Darmstadt, Germany) were used as control samples...The analysis revealed 20-30% of protein impurities and a significant presence of oxidized forms in the HP-hMG samples. These findings are critical for understanding the quality, safety, and clinical profile of HP-hMG."

Journal

Quality evaluation of highly purified human menopausal gonadotropin preparations by means of gel electrophoresis and mass spectrometry. (PubMed, Pharmazie) - "MS analysis proved to be a powerful tool for the identification and detailed characterization of the gonadotropins and the relevant peptides were identified with high sequence coverages. The results of this study are not only useful for the quality assessment of this class of complex biopharmaceuticals but may also serve as a supporting platform for further development of biopharmaceuticals based on modulation of the glycosylation pattern to enhance efficacy or reduce side effects."

Journal

Effects of different gonadotropin preparations in GnRH antagonist protocol for patients with polycystic ovary syndrome during IVF/ICSI: a retrospective cohort study. (PubMed, Front Endocrinol (Lausanne)) - "To compare the effects of recombinant FSH alfa (rFSH-alfa), rFSH-beta, highly purified human menopausal gonadotropin (HP-hMG) and urinary FSH (uFSH) in women with polycystic ovarian syndrome who have undertaken the GnRH antagonist protocol during IVF/ICSI treatment. For women with PCOS undergoing the GnRH antagonist protocol, the clinical pregnancy rates of fresh IVF/ICSI-ET cycle are similar for all four types of Gn. With a lower risk of OHSS and a similar number of high-quality and available embryos, HP-hMG may have an advantage in the PCOS population."

Journal • Retrospective data • Polycystic Ovary Syndrome

A direct healthcare cost analysis of recombinant LH versus hMG supplementation on FSH during controlled ovarian hyperstimulation in the GnRH-antagonist protocol. (PubMed, Arch Gynecol Obstet) - "The cost analysis showed that recombinant LH is more cost-effective than hMG supplementation on r-hFSH during COH in the GnRH-antagonist protocol."

Cost-analysis • HEOR • Journal

Highly Purified Human Menopausal Gonadotropin (HP-hMG) Versus Recombinant Follicle-Stimulating Hormone (rFSH) for Controlled Ovarian Stimulation in US Predicted High-Responder Patients: A Cost-Comparison Analysis. (PubMed, Pharmacoecon Open) - "Comparable clinical outcomes can be achieved at a lower cost when using HP-hMG versus rFSH based COS protocols in a cohort of predicted high-responders. Such cost savings may reduce the economic burden infertility currently presents to US healthcare providers and those seeking fertility care."

HEOR • Journal • Reimbursement • US reimbursement • Gynecology • Infertility • Sexual Disorders

Analysis of Nurse and Patient Preferences for Pre-Filled Pen Devices for Self-Injection of Highly Purified Human Menopausal Gonadotropin (HP-hMG, MENOPUR). (PubMed, Patient Prefer Adherence) - "The prototype pen was perceived to possess the key attributes considered important for a gonadotropin pen by patients and nurses, including correcting the dose, the ability to self-inject safely and correctly, ease of preparation and use, and an injection which appeared to be as painless as possible. The prototype pen was found to perform well across all key attributes, especially those considered most important in gonadotropin pens, suggesting that it is a user-friendly option for patients undergoing ART."

Journal • Pain

Impact of TROP-2 and its cellular localization on prognosis of breast cancer in the GAIN cohort (ESMO-BC 2023) - P3 | "For mTROP-2, a product score (IRS) of grouped percentage and staining intensity showed better DFS and OS for IRS > 3 (also identified by Cutoff Finder) in HER2+/HRany and HER2+/HR+ patients (uni-/multivariate)...The results are relevant for biomarker strategies for future therapeutic concepts. In the SASCIA trial investigating Sacituzumab TROP-2 is prospectively assessed."

Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2 • TROP2

"@mtropea08 might have something..." (@josephnparsons)

Comparative effectiveness of gonadotropins used for ovarian stimulation during assisted reproductive technologies (ART) in France: A real-world observational study from the French nationwide claims database (SNDS). (PubMed, Best Pract Res Clin Obstet Gynaecol) - "This comparative non-interventional study using data from the French National Health Database (Système National des Données de Santé) investigated real-world (cumulative) live birth outcomes following ovarian stimulation, leading to oocyte pickup with either originator recombinant human follicle-stimulating hormone (r-hFSH) products (alfa or beta), r-hFSH alfa biosimilars, or urinary highly purified human menopausal gonadotropins (HP-hMG). Using data from 245,534 stimulations (153,600 women), biosimilars resulted in a 19% lower live birth (adjusted odds ratio (OR) 0.81, 95% confidence interval (CI) 0.76-0.86) and a 14% lower cumulative live birth (adjusted hazard ratio (HR) 0.86, 95% CI 0.82-0.89); and HP-hMG resulted in a 7% lower live birth (adjusted OR 0.93, 95% CI 0.90-0.96) and an 11% lower cumulative live birth (adjusted HR 0.89, 95% CI 0.87-0.91) versus originator r-hFSH alfa. Results were consistent across strata (age and ART strategy), sensitivity..."

Claims database • HEOR • Journal • Observational data • Real-world • Real-world evidence • Review

Analytical investigation of the profile of human chorionic gonadotropin in highly purified human menopausal gonadotrophin preparations (Fertility 2023) - "Objective: Highly-purified human menopausal gonadotropin (HP-hMG [Menopur, Ferring Pharmaceuticals, Switzerland]) contains 1:1 follicle-stimulating hormone (FSH) and luteinizing hormone (LH) activity...The reference was a mixture of r-hFSH/follitropin-alfa (GONAL-f), r-hLH/lutropin alfa [Luveris] and r-hCG (Ovidrel) (Merck KGaA, Darmstadt, Germany) constituted based on their reported activity (in IU) in the HP-hMG product label... Advanced molecular analysis of HP-hMG showed that the relative presence of hCG compared to LH may be higher than in the reference, and revealed absence of sulfated glycans, suggesting a mainly placental origin of hCG, with possible impact on receptor affinity/activation and clinical effect."

Follitropin Alpha for assisted reproduction: an analysis based on a non-interventional study in Greece. (PubMed, Curr Med Res Opin) - "The live birth rate, cost per oocyte, and the cost per live birth are in line with literature. OSI was a main contributing factor to the accurate prediction of the live birth rate, while age and BMI were found to be negatively correlated."

Journal • Observational data • Gynecology • Infertility • Sexual Disorders

Consecutive versus concomitant follicle-stimulating hormone and highly purified human menopausal gonadotropin: A milder response but better quality. (PubMed, Clin Exp Reprod Med) - "Personalized controlled ovarian stimulation using HP-hMG during the late follicular phase led to a significantly lower response, but did not affect the quality of ICSI."

Journal • FAS

Added value of anti-Müllerian hormone serum concentration in assisted reproduction clinical practice using highly purified human menopausal gonadotropin (HP-hMG). (PubMed, J Gynecol Obstet Hum Reprod) - "Selecting the appropriate starting dose of gonadotropin is crucial to optimize the IVF/ICSI procedure. For the first attempt, the serum AMH level is a good biomarker to individualize treatment."

Clinical • Journal • Gynecology • Infertility

First pre-filled pen device with highly purified human menopausal gonadotropin (HP-hMG, Menopur) in liquid is shown to be bioequivalent to powder for reconstitution. (PubMed, Int J Clin Pharmacol Ther) - "The 90% CIs for the geometric mean ratios of serum FSH AUC and C were both within 0.8000 - 1.2500, thus the two formulations are bioequivalent."

Journal

Phosphorylation of MtRopGEF2 by LYK3 mediates MtROP activity to regulate rhizobial infection in Medicago truncatula. (PubMed, J Integr Plant Biol) - "Activated MtRac1 was found to localize at the tips of root hairs and to strongly interact with LYK3 and NFP. Taken together, our results support the hypothesis that MtRac1, LYK3, and NFP form a polarly localized receptor complex that regulates root hair deformation during rhizobial infection."

Journal • Infectious Disease

Comparative effectiveness of recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa) versus highly purified urinary human menopausal gonadotropin (hMG HP) in assisted reproductive technology (ART) treatments: a non-interventional study in Germany. (PubMed, Reprod Biol Endocrinol) - "This large (> 28,000 women), real-world study demonstrated significantly higher rates of cumulative live birth, cumulative ongoing pregnancy and cumulative clinical pregnancy with r-hFSH-alfa versus hMG HP."

Clinical • HEOR • Journal • Observational data

Successful live birth after in vitro maturation treatment in a patient with autoimmune premature ovarian failure: a case report and review of the literature. (PubMed, Gynecol Endocrinol) - "IVM of immature oocytes was performed after the administration of 150 IU highly purified human menopausal gonadotropin for three consecutive days and an injection of 10,000 IU human chorionic gonadotropin to trigger ovulation. Management of reproductive age women with autoimmune pathology requires fertility counseling. Early diagnosis of autoimmune POF is important for early conception and oocyte preservation, because the only other option at present is ovum donation."

Journal • Preclinical • Review • Diabetes • Endocrine Disorders • Immunology • Infertility • Metabolic Disorders • Nephrology • Renal Disease • Sexual Disorders • Women's Health

The Effect of Lockdown Period during the COVID-19 Pandemic on Air Quality in Sydney Region, Australia. (PubMed, Int J Environ Res Public Health) - "The results from both statistical and modelling methods show that NO, CO, and PM levels decreased during the lockdown, but O instead increased. However, the change in the concentration levels are small considering the large reduction of ~30% in traffic volume."

Journal • Infectious Disease • Novel Coronavirus Disease