Menopur (menotropin) / Ferring - LARVOL DELTA

HEART: Hormone Evaluation in Artificial Reproductive Technology (clinicaltrials.gov) - P=N/A | N=810 | Completed | Sponsor: Lund University | Phase classification: P4 ➔ P=N/A | Trial completion date: Jun 2024 ➔ Oct 2024

Phase classification • Trial completion date • Gynecology • Infertility • Sexual Disorders

Dydrogesterone is an eligible tool to suppress LH surge in assisted reproduction technologies (ART) cycles. (PubMed, JBRA Assist Reprod) - "DYG is an eligible tool for IVF/ICSI cycles intended to freeze-all and oocyte preservation, embryo banking, and preventing OHSS in patients with high AMH levels."

Journal • Endometriosis • Gynecology • Women's Health

Chemotherapy-induced diminished murine ovarian reserve model and impact of low-dose chemotherapy on fertility. (PubMed, F S Sci) - "We successfully established a chemotherapy-induced DOR model using 12 mg/kg Bu + 120 mg/kg Cy, as evidenced by lower, but not completely depleted, follicle numbers and fewer retrieved embryos. Histological study of ovarian tissue exposed to DOR-inducing chemotherapy revealed that surviving follicles were of the same quality as tissue not exposed to chemotherapy."

Journal • Preclinical • CASP3

Cumulative Pregnancy Rate With Lower and Higher Gonadotropin Dose During IVF Among Poor Responders (clinicaltrials.gov) - P=N/A | N=190 | Completed | Sponsor: Peter Kovacs MD | Recruiting ➔ Completed | N=700 ➔ 190

Enrollment change • Trial completion • Infertility • Sexual Disorders

IMPACT OF GONADOTROPIN SELECTION ON RISK OF OVARIAN HYPERSTIMULATION SYNDROME (OHSS) IN PREDICTED HIGH RESPONDERS UNDERGOING OVARIAN STIMULATION: A MEGASET HR TRIAL ANALYSIS (ASRM 2024) - "OBJECTIVE To evaluate risk of developing OHSS with use of highly purified human menotropin (HP-hMG) versus recombinant follicle stimulating hormone (rFSH) for ovarian stimulation in predicted high responder patients. Safety considerations in high-responders could drive improved protocol individualization based on gonadotropin type. Further studies are warranted to explore the potential protective mechanism of HP-hMG in these patients."

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

HEART: Hormone Evaluation in Artificial Reproductive Technology (clinicaltrials.gov) - P4 | N=796 | Completed | Sponsor: Lund University | Trial completion date: Dec 2020 ➔ May 2024

Adverse events • Biomarker • Trial completion date • Gynecology • Infertility • Sexual Disorders

Vaginal micronized progesterone on preventing luteinizing hormone untimely surge in ART cycles: A prospective proof-of-concept study. (PubMed, JBRA Assist Reprod) - "Progestin-Primed Ovarian Stimulation with micronized vaginal progesterone seems to be a compelling choice for preventing premature ovulation without compromising oocyte quality in women undergoing ovarian stimulation."

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

Modified Rekovelle and Menopur Combination Protocol to Avoid Monitoring Before Day 10 of Stimulation (clinicaltrials.gov) - P=N/A | N=772 | Completed | Sponsor: Clinique Ovo | Active, not recruiting ➔ Completed | N=390 ➔ 772

Enrollment change • Trial completion • Infertility • Sexual Disorders

Reply of the authors: Randomized, assessor-blinded trial comparing highly purified human menotropin and recombinant follicle-stimulating hormone in high responders undergoing intracytoplasmic sperm injection. (PubMed, Fertil Steril) - No abstract available

Journal

HRT Versus MOS for Endometrial Preparation Prior to FET in Non PCOS Patients (clinicaltrials.gov) - P4 | N=150 | Recruiting | Sponsor: Mansoura University | Unknown status ➔ Recruiting | Trial completion date: Mar 2021 ➔ Dec 2024 | Trial primary completion date: Jan 2021 ➔ Dec 2024

Enrollment open • Trial completion date • Trial primary completion date • Infertility • Polycystic Ovary Syndrome • 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

CS-EOSP-ICSI: Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Female Infertility (clinicaltrials.gov) - P1/2 | N=200 | Completed | Sponsor: Lebanese University | Active, not recruiting ➔ Completed | Phase classification: PN/A ➔ P1/2 | Trial completion date: Dec 2021 ➔ May 2023

Phase classification • Trial completion • Trial completion date • Endometriosis • Gynecology • Infectious Disease • Infertility • Polycystic Ovary Syndrome • Sexual Disorders • Uterine Leiomyoma • Women's Health

CREATION AND VALIDATION OF A CLAIMS-BASED ALGORITHM FOR IDENTIFYING IN-VITRO FERTILIZATION SERVICES (AUA 2018) - " The best performing claims-based algorithm used a combination of two or more pelvic ultrasounds (CPT 76830, 76856, or 76857) within two days of each other plus a prescription for either menotropin or ganirelix within 58 or 88 days of the most recent ultrasound, respectively. A claims-based algorithm using paired pelvic ultrasounds and hormonal medications commonly used for IVF has high sensitivity, specificity, NPV, and accuracy for predicting IVF cycles. This algorithm will be useful for researchers, policymakers, and clinicians who aim to better understand large scale IVF practice patterns using administrative claims data."

Preclinical • Biosimilar • Infertility • Long-acting Reversible Contraceptives • Ophthalmology

Modified Rekovelle and Menopur Combination Protocol to Avoid Monitoring Before Day 10 of Stimulation (clinicaltrials.gov) - P=N/A | N=390 | Active, not recruiting | Sponsor: Clinique Ovo

New trial • Infertility • Sexual Disorders

Retrospective Analysis of Real-world Data From Medical Records on the Use of MENOPUR for Infertility Treatment (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: Ferring Pharmaceuticals | N=1000 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Real-world • Real-world evidence • Trial withdrawal • Infertility • Sexual Disorders

A Study Comparing MENOPUR in a Pen Formulation With a Powder and Solvent Formulation in Healthy Women (clinicaltrials.gov) - P1 | N=95 | Completed | Sponsor: Ferring Pharmaceuticals | Recruiting ➔ Completed

Trial completion • Infertility • Sexual Disorders • CRP

Retrospective Analysis of Real-world Data From Medical Records on the Use of MENOPUR for Infertility Treatment (clinicaltrials.gov) - P=N/A | N=1000 | Not yet recruiting | Sponsor: Ferring Pharmaceuticals | Trial completion date: May 2022 ➔ Sep 2023 | Trial primary completion date: May 2022 ➔ Sep 2023

Real-world evidence • Trial completion date • Trial primary completion date • Infertility • Sexual Disorders

Cumulative Pregnancy Rate With Lower and Higher Gonadotropin Dose During IVF Among Poor Responders (clinicaltrials.gov) - P=N/A | N=700 | Recruiting | Sponsor: Peter Kovacs MD | Not yet recruiting ➔ Recruiting

Enrollment open • Infertility • Sexual Disorders

HEART: Hormone Evaluation in Artificial Reproductive Technology (clinicaltrials.gov) - P4 | N=796 | Completed | Sponsor: Lund University | Recruiting ➔ Completed

Adverse events • Biomarker • Trial completion • Gynecology • 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

MEDAM (Menopur Retrospective Data prograM) (clinicaltrials.gov) - P=N/A; N=11488; Completed; Sponsor: Ferring Pharmaceuticals; Recruiting ➔ Completed; N=8126 ➔ 11488

Enrollment change • Retrospective data • Trial completion • Infertility • Sexual Disorders

Recombinant follicular stimulating hormone plus recombinant luteinizing hormone versus human menopausal gonadotropins- does the source of LH bioactivity affect ovarian stimulation outcome? (PubMed, Reprod Biol Endocrinol) - "The differences in treatment outcome, derived by different LH preparations reflect the distinct physiological role of these molecules. Our findings may assist in tailoring a specific gonadotropin regimen when assembling an OS protocol."

Journal

MEDAM (Menopur Retrospective Data prograM) (clinicaltrials.gov) - P=N/A; N=8126; Recruiting; Sponsor: Ferring Pharmaceuticals; Initiation date: May 2021 ➔ Nov 2021

Retrospective data • Trial initiation date • Infertility • Sexual Disorders