Orgalutran (ganirelix acetate) / Organon - LARVOL DELTA

Real-World Safety and Effectiveness of Ganirelix for Ovarian Stimulation in Chinese Women: A Multicenter, Prospective, Single-Arm, Observational Study. (PubMed, Womens Health Rep (New Rochelle)) - "This study indicates that the safety profile and effectiveness of ganirelix were clinically acceptable, and no new safety signals emerged in real-world clinical practice for Chinese women with OS. The study was registered on Chinadrugtrial.org (identifier: CTR20150284) (http://www.chinadrugtrials.org.cn) and ENCePP.eu (identifier: EUPAS8737) (https://catalogues.ema.europa.eu)."

Journal • Observational data • Real-world evidence

Gas Challenge: Human Cerebral Blood Flow Regulation (clinicaltrials.gov) - P1 | N=110 | Completed | Sponsor: University of Wisconsin, Madison | Recruiting ➔ Completed | Trial completion date: Jul 2026 ➔ May 2025 | Trial primary completion date: Jul 2025 ➔ Mar 2025

Trial completion • Trial completion date • Trial primary completion date • Cardiovascular

To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects (clinicaltrials.gov) - P3 | N=317 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed | Trial primary completion date: Oct 2024 ➔ May 2025

Head-to-Head • Trial completion • Trial primary completion date • Infertility • Sexual Disorders

Hormonal Mechanisms of Sleep Restriction - Axis Study (clinicaltrials.gov) - P1 | N=80 | Active, not recruiting | Sponsor: Peter y. Liu | Trial completion date: Mar 2025 ➔ Jun 2026

Trial completion date

Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women (clinicaltrials.gov) - P1 | N=5 | Active, not recruiting | Sponsor: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Trial completion date: Jul 2024 ➔ Jun 2026

Trial completion date

Comparison of pregnancy outcomes and safety between cetrorelix and ganirelix in IVF/ICSI antagonist protocols: a retrospective cohort study. (PubMed, Front Reprod Health) - "Cetrorelix offering enhanced endometrial receptivity (66.2% Type A morphology) and safety advantages. These findings support cetrorelix's role in optimizing ART safety without compromising efficacy."

Journal • Retrospective data

SOPKGANI: Sub-therapeutic GnRH- Antagonist Treatment to Rectify LH Pulsatility in Lean Women With PCOS. (clinicaltrials.gov) - P1 | N=20 | Completed | Sponsor: University Hospital, Lille | Not yet recruiting ➔ Completed | Trial completion date: Jul 2024 ➔ Feb 2025 | Trial primary completion date: Jul 2024 ➔ Feb 2025

Trial completion • Trial completion date • Trial primary completion date • Polycystic Ovary Syndrome

Post-marketing safety profile of ganirelix in women: a 20-year pharmacovigilance analysis of global adverse drug event databases (2004-2024). (PubMed, BMC Pharmacol Toxicol) - "This study provides a robust real-world safety evaluation of ganirelix, with findings corroborated by two independent pharmacovigilance databases. While consistent with clinical observations, the identification of unexpected signals warrants further pharmacoepidemiological investigations to confirm these results."

Adverse events • Journal • P4 data • Dermatitis • Dermatology • Immunology • Pain

Gas Challenge: Human Cerebral Blood Flow Regulation (clinicaltrials.gov) - P1 | N=111 | Recruiting | Sponsor: University of Wisconsin, Madison | Trial primary completion date: Mar 2025 ➔ Jul 2025

Trial primary completion date • Cardiovascular

Freeze-all indications in women with subfertility undergoing IVF: a cohort study. (PubMed, Reprod Biomed Online) - "The preferred treatment strategy in the study cohort was to freeze all available embryos, mainly because of planned preimplantation genetic testing and to avoid the risk of ovarian hyperstimulation syndrome."

Journal • Infertility

Reduction in minipubertal gonadotropin levels alters reproductive lifespan and ovarian follicular loss in female mice. (PubMed, Hum Reprod) - "This study, which is the first to investigate the physiological role of minipuberty on reproductive parameters, supports the idea that suppressing the high postnatal levels of gonadotropins may have long-term effects on female fertility by extending the duration of reproductive life. Perturbations in gonadotropin levels during this period of life, such as those observed in infants born prematurely, may thus have profound consequences on late reproductive functions."

Journal • Preclinical • Inflammation • CYP19A1 • INHBB

GnRH Peptide Antagonist: Comparative Analysis of Chemistry and Formulation with Implications for Clinical Safety and Efficacy. (PubMed, Pharmaceuticals (Basel)) - "Key GnRH peptide antagonists authorized by the regulatory agencies include Cetrorelix, Ganirelix, Abarelix, Degarelix, and Teverelix. All GnRH peptide-based antagonists were analyzed in detail for formulation strategy, pharmacokinetics, effectiveness, and safety. This review also emphasizes GnRH antagonists' clinical promise, providing insights into their evolution and the possibility for future research in developing safer, more effective treatments for complicated hormonal diseases."

Journal • Review • Cardiovascular • Endometriosis • Genito-urinary Cancer • Gynecology • Oncology • Prostate Cancer • Solid Tumor • Uterine Leiomyoma • Women's Health

PRO_NAT: Efficacy of Micronized Natural Progesterone Vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation. (clinicaltrials.gov) - P4 | N=150 | Recruiting | Sponsor: Instituto Bernabeu | Trial completion date: Dec 2024 ➔ Aug 2025

Trial completion date

The role of elagolix in ovulation suppression during controlled ovarian stimulation: a retrospective cohort study. (PubMed, F S Rep) - "To compare in vitro fertilization treatment outcomes for the oral gonadotropin-releasing hormone (GnRH) antagonist elagolix (E) to the conventionally used injectable GnRH antagonist ganirelix (G) for achieving pituitary gonadotropin suppression during a controlled ovarian stimulation (COS) cycle. None of the differences reached significance. The oral GnRH antagonist, E, may be as effective as the injected antagonist, G, regarding embryological and clinical outcomes and could offer a less invasive, more cost-effective, and "patient-friendly" approach to pituitary suppression for in vitro fertilization treatment."

Journal • Retrospective data • Gynecology • Infertility • Sexual Disorders

V-RISES: Disentangling the Effects of Daily Stress, Sleep, and Sex Hormones on Accelerated Vascular Aging in Midlife Women (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: University of Delaware

New P4 trial

ANGAS: To Investigate Efficacy and Safety of a Single Injection of GenSci094 for Ovarian Stimulation Using Daily Recombinant FSH as Reference (clinicaltrials.gov) - P3 | N=176 | Completed | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Aug 2024 ➔ Jan 2024

Head-to-Head • Trial completion • Trial completion date • Infertility • Sexual Disorders

The impact of oral multinutrient supplementation on in vitro fertilisation or intracytoplasmic sperm injection outcomes: A prospective controlled study. (PubMed, Med J Malaysia) - "A multinutrient supplementation given for a minimum of 28 days, may have a positive effect on FORT and lower use of gonadotropin. More and larger sample research is warranted to prove this effect."

Journal • Preclinical • Gynecology

PRO_NAT: Efficacy of Micronized Natural Progesterone Vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation. (clinicaltrials.gov) - P4 | N=150 | Recruiting | Sponsor: Instituto Bernabeu | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2024 ➔ Dec 2024 | Trial primary completion date: Jun 2024 ➔ Dec 2024

Enrollment open • Trial completion date • Trial primary completion date

PPDUO: Protocol with Progestin-primed Ovarian Stimulation (PPOS) from the Beginning of Stimulation Versus Protocol with GnRH Antagonists for Ovarian Stimulation in Patients Undergoing DUOSTIM with Embryo Accumulation for PGT-A. (clinicaltrials.gov) - P4 | N=144 | Not yet recruiting | Sponsor: Ginefiv

New P4 trial

To Compare the Efficacy and Safety of Oral SHR 7280 Tablets With Ganirelix Acetate Injection in Infertile Female Subjects (clinicaltrials.gov) - P3 | N=317 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Head-to-Head • Infertility • Sexual Disorders

RECOS: Possible Action of Resveratrol in Improving the Outcomes of IVF/ICSI in Couples With Unexplained Infertility (clinicaltrials.gov) - P=N/A | N=90 | Recruiting | Sponsor: Andros Day Surgery Clinic

New trial • Infertility • Sexual Disorders

Two livebirths achieved in cases of hypergonadotropic hypogonadism nonobstructive azoospermia, treated with GnRH agonist and gonadotrophins: a case series and review of the literature. (PubMed, JBRA Assist Reprod) - "On the third day of the cycle, menotropin daily doses was administered. When at least one follicle ≥14 mm was visualized, pituitary blockage was performed using GnRH antagonist ganirelix. When three or more follicles attained a mean diameter of ≥17 mm, triptorelin acetate was administered to trigger final follicular maturation...In this report we present a successful strategy for hypergonadotropic hypogonadism AOA men, as an alternative approach to the surgical testicular sperm recovery. Nevertheless, prospective randomized trials are needed to confirm our findings."

Journal • Review • Endocrine Disorders • Infertility • Sexual Disorders

PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study (clinicaltrials.gov) - P4 | N=60 | Not yet recruiting | Sponsor: University Hospital, Ghent | Initiation date: Apr 2024 ➔ Jul 2024

Trial initiation date

THE IMPACT OF ORAL MULTINUTRIENT SUPPLEMENTATION ON FERTILITY OUTCOMES IN IN- VITRO FERTILIZATION OR INTRACYTOPLASMIC SPERM INJECTION (IVF/ICSI) IN MALAYSIAN POPULATION– A PROSPECTIVE CONTROLLED STUDY (ASPIRE 2024) - "Antagonists (Orgalutran) were commenced when the leading follicle reached a diameter of 11 mm...Conclusion A micronutrient supplementation given for a minimum of 28 days, may have a positive effect on FORT. More research is warranted to prove this effect."

Clinical • Gynecology • Infertility • Sexual Disorders

Drug-Leachable Interaction Product Evaluation in Prefilled Syringe of Ganirelix Acetate Injection. (PubMed, J Pharm Sci) - "Characterization of the impurities was carried out through data obtained from MS and MS/MS analysis, revealing them as polyacrylic acid-ganirelix adduct impurities. This study offers valuable insights into identifying leachable and susceptible sites, providing a foundation for potential modifications in similar classes of drug products, thereby enhancing their safety and efficacy."

Journal