Choriomon (human choriomon gonadotropin (hCG)) / IBSA Institute Biochemical SA - LARVOL DELTA

Does repeated ovarian hyperstimulation alter thermal- and mechanical-induced nociceptive behaviour? (IASP 2024) - "Repeated ovarian hyperstimulation does not alter thermal- and mechanical-induced nociceptive behaviours in mice. The results highlight the need for more animal studies that can understand the mechanisms involved in nociceptive changes induced by ovulation-inducing drugs."

Repeated ovarian hyperstimulation in female mice does not induce ovarian fibrosis (ASRI 2024) - "ROH in female mice did not cause fibrosis in the ovarian stroma."

Preclinical • Fibrosis • Immunology • Infertility • Obesity • Sexual Disorders • CD163 • CD63 • CD68

Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS (clinicaltrials.gov) - P4 | N=300 | Completed | Sponsor: Mohamed Sayed Abdelhafez | Unknown status ➔ Completed | N=100 ➔ 300 | Trial completion date: May 2020 ➔ Jan 2023 | Trial primary completion date: Apr 2020 ➔ Jan 2023

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Infertility • Polycystic Ovary Syndrome • Sexual Disorders

HCG Levels After Ovulation Triggering as Predictors of ICSI Outcome (clinicaltrials.gov) - P=N/A | N=100 | Completed | Sponsor: Mansoura University

New trial • Infertility • Sexual Disorders

KLIN-HEALTH: Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome (clinicaltrials.gov) - P3 | N=120 | Recruiting | Sponsor: Georgios Papadakis | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders

CAN THE DUAL TRIGGER PROTOCOL IMPACT EMBRYO PLOIDIA? (ASRM 2022) - "The groups were Choriomon group with 18 patients (CG), Gonapeptyl group with 452 patients (GG), Lupron group with 67 patients (LG), Ovidrel group with 87 patients (OG), Gonapeptyl plus Choriomon group with 478 patients (GCG). This study demonstrated that the dual trigger protocol was not superior to other trigger protocols and that when compared to the trigger protocol with Gonapeptyl, the dual trigger had a lower rate of embryonic euploidy. IMPACT STATEMENT: The results of this study may assist in the selection of patients who may benefit from the dual trigger protocol. In addition, the study will contribute to the development of new studies to better understand the processes of ovulation induction and its effect on embryonic aneuploidies."

Clinical

KLIN-HEALTH: Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome (clinicaltrials.gov) - P3 | N=120 | Not yet recruiting | Sponsor: Georgios Papadakis

New P3 trial • Genetic Disorders

COMPARING TWO PROTOCOLS FOR FINAL OOCYTE MATURATION IN POOR RESPONDERS UNDERGOING GnRH-ANTAGONIST ICSI CYCLES (clinicaltrials.gov) - P3 | N=160 | Not yet recruiting | Sponsor: Alexandria University

New P3 trial • Infertility • Sexual Disorders

Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders (clinicaltrials.gov) - P3 | N=90 | Completed | Sponsor: El Shatby University Hospital for Obstetrics and Gynecology | Not yet recruiting ➔ Completed | Trial completion date: Dec 2021 ➔ Sep 2021 | Trial primary completion date: Sep 2021 ➔ Mar 2021

Trial completion • Trial completion date • Trial primary completion date • Infertility • Sexual Disorders

Randomized Pharmacokinetic Study of a Highly Purified Human Chorionic Gonadotropin and of a Recombinant Human Chorionic Gonadotropin Following Single Subcutaneous Administration in Healthy Women. (PubMed, Clin Drug Investig) - P1 | "The differences between Choriomon and Ovitrelle pharmacokinetic parameters can be ascribed to the different raw source of the products and are reflected in the approved dose regimens of the two hCG formulations. The observed lack of bioequivalence between the two compounds at the given doses is not clinically relevant, as results from Phase III studies indicated similar clinical efficacy and safety. The safety data are in line with the known safety profile of the two products. CLINICALTRIALS."

Journal • PK/PD data

Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders (clinicaltrials.gov) - P3; N=140; Completed; Sponsor: American University of Beirut Medical Center; Recruiting ➔ Completed

Trial completion

Freeze All on Oocyte Maturatin by Gonadotropin Agonist Versus Human Chorionic Gonadotroipin (clinicaltrials.gov) - P=N/A; N=100; Not yet recruiting; Sponsor: Aljazeera Hospital

New trial • Infertility • Sexual Disorders

Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders (clinicaltrials.gov) - P3; N=80; Not yet recruiting; Sponsor: El Shatby University Hospital for Obstetrics and Gynecology

Clinical • New P3 trial • Infertility • Sexual Disorders

AIPRICSI: Role of Aromatase Inhibitor to Enhance Ovulation in Poor Responder During Induction With Short Antagonist Protocol in Cases of ICSI (clinicaltrials.gov) - P4; N=20; Recruiting; Sponsor: Minia University; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar

Comparative Bioavailability Study of Human Chorionic Gonadotropin (hCG)-IBSA Versus a Marketed hCG Formulation (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: IBSA Institut Biochimique SA

New P1 trial • Biosimilar • Infertility • Long-acting Reversible Contraceptives • Sexual Disorders • Women's Health

Evaluation of Different Luteal Phase Support Methods in Patients With Poor Ovarian Response (clinicaltrials.gov) - P3; N=210; Recruiting; Sponsor: Royan Institute

New P3 trial • Biosimilar

Stimulated Versus Un-stimulated Intrauterine Insemination Cycles in Women With Endometriosis (clinicaltrials.gov) - P3; N=450; Recruiting; Sponsor: Cairo University; Not yet recruiting -> Recruiting

Enrollment open • Biosimilar • Endometriosis

Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS (clinicaltrials.gov) - P4; N=100; Recruiting; Sponsor: Mohamed Sayed Abdelhafez; Trial completion date: Feb 2020 ➔ May 2020; Trial primary completion date: Jan 2020 ➔ Apr 2020

Clinical • Trial completion date • Trial primary completion date • Endocrine Disorders • Infertility • Long-acting Reversible Contraceptives • Polycystic Ovary Syndrome • Sexual Disorders • Women's Health

Dual Trigger in the Final Oocyte Maturation in Poor Ovarian Responders (clinicaltrials.gov) - P3; N=140; Recruiting; Sponsor: American University of Beirut Medical Center

Clinical • New P3 trial

Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS (clinicaltrials.gov) - P4; N=100; Recruiting; Sponsor: Mohamed Sayed Abdelhafez; Trial completion date: Sep 2019 ➔ Feb 2020; Trial primary completion date: Aug 2019 ➔ Jan 2020

Trial completion date • Trial primary completion date

Comparative Bioavailability Study of Human Chorionic Gonadotropin (hCG)-IBSA Versus a Marketed hCG Formulation (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: IBSA Institut Biochimique SA; Recruiting ➔ Completed; Trial primary completion date: May 2019 ➔ Aug 2019

Clinical • Trial completion • Trial primary completion date

Triggering of Follicular Maturation (clinicaltrials.gov) - P3; N=160; Completed; Sponsor: Assiut University; Recruiting ➔ Completed

Clinical • Trial completion

Comparative Bioavailability Study of Human Chorionic Gonadotropin (hCG)-IBSA Versus a Marketed hCG Formulation (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: IBSA Institut Biochimique SA; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open