Elonva (corifollitropin alfa) / Organon - LARVOL DELTA

A novel long-acting recombinant follicle-stimulating hormone with hyperglycosylation exhibits improved pharmacokinetic and bioactivity on promoting follicle growth. (PubMed, Biochem Pharmacol) - "Although Recombinant human FSH (rh-FSH) and long-acting FSH analogs, such as FSH-CTP (Elonva), have been used to treat infertility for many years...Furthermore, increased activities in terms of ovary weight gain and superovulations were verified in rats. In conclusion, the designed hyperglycosylated FSH164 exhibits a prolonged metabolic duration, with a single dose of FSH164 possessing bioactivity comparable to that of multiple rh-FSH injections, suggesting that it has great potential as a therapy for infertility."

Journal • PK/PD data • Infertility • Sexual Disorders

Randomized controlled trial to evaluate the impact of follicle priming on IVM outcomes in women with polycystic ovaries: CFA versus FSH-B. (PubMed, Hum Reprod) - P3 | "While follicle priming for IVM using one injection of CFA in subfertile patients with high AFC results in a trend towards lower oocyte retrieval rates compared to daily injections of FSH-B, the use of CFA in IVM cycles is safe, convenient, and as efficacious as priming with FSH-B."

Journal • Polycystic Ovary Syndrome

Comparing IVF/ICSI Cycle Outcomes of Post Ovulation Ovarian Stimulation Protocol with Elonva Without GnRH Antagonist to Follicular Phase Day 2 Stimulation Fixed Day 5 Antagonist Protocol (clinicaltrials.gov) - P=N/A | N=252 | Not yet recruiting | Sponsor: ART Fertility Clinics LLC

New trial

One-shot Ovarian Stimulation Protocol (One-shot) (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Fundación Santiago Dexeus Font | Trial completion date: Jan 2025 ➔ Apr 2025 | Trial primary completion date: Jan 2025 ➔ Apr 2025

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

Development of a Long-Acting Follicle-Stimulating Hormone Using Serum Albumin Fab-Associated Technology for Female Infertility. (PubMed, Endocrinol Metab (Seoul)) - "Even corifollitropin alfa, with an extended half-life, requires supplementary injections of rhFSH after 7 days...These findings suggest that SAFA-FSH presents a promising alternative to current rhFSH treatments for female infertility. However, further research is essential to thoroughly assess its safety and efficacy in clinical contexts."

Journal • Gynecology • Infertility • Sexual Disorders

One-shot Ovarian Stimulation Protocol (One-shot) (clinicaltrials.gov) - P=N/A | N=20 | Recruiting | Sponsor: Fundación Santiago Dexeus Font | Not yet recruiting ➔ Recruiting

Enrollment open • Infertility • Sexual Disorders

One-shot Ovarian Stimulation Protocol (One-shot) (clinicaltrials.gov) - P=N/A | N=20 | Not yet recruiting | Sponsor: Fundación Santiago Dexeus Font

New trial • Infertility • Sexual Disorders

Therapeutic management in women with a diminished ovarian reserve: a systematic review and meta-analysis of randomized controlled trials. (PubMed, Fertil Steril) - "Specific interventions such as testosterone seem to correlate with a better live birth rate in women with diminished ovarian reserve; these findings should be further explored in randomized trials."

Journal • Retrospective data • Review

Reproductive outcome after in vitro fertilization in endometriosis - key factors and implications. (PubMed, J Med Life) - "Our study revealed that treatment with corifollitropin alfa in the endometriosis group was associated with a higher clinical pregnancy rate. AMH and age proved to be significant independent factors for the reproductive outcome."

Journal • Preclinical • Retrospective data • Endometriosis • Gynecology • Infertility • Inflammation • Pain • Sexual Disorders • Women's Health

Pretreatment with luteal estradiol for programming antagonist cycles compared to no pretreatment in advanced age women stimulated with corifollitropin alfa: a non-inferiority randomized controlled trial. (PubMed, Hum Reprod) - P3 | "Programming antagonist cycles with luteal E2 pretreatment seems a useful tool in advanced age women to better schedule oocyte retrievals on working days. However, the potential benefit of the number of collected oocytes remains to be demonstrated in a larger population displaying the characteristics of decreased ovarian reserve encountered in Poseïdon classification."

Head-to-Head • Journal • Metastases • Gynecology

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

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

Single-chain human follicle-stimulating hormone with a di-N-glycosylated linker. (PubMed, Theriogenology) - "Our data show that sc-hFSH L0N and sc-hFSH LNN produced from both cell lines stimulate cAMP and progesterone production in mLTC cells expressing hFSH receptors and exhibit similar B/I (in vitro Bioactivity/Immuno activity) ratios. Finally, the ratio of in vivo/in vitro bioactivities for sc-hFSH LNN relative to natural pituitary heterodimeric hFSH increased 8-fold, most likely because of a longer half-life in the blood."

Journal

PE-PMA: Reduction of Progesterone Elevation at Trigger in POR After Long Acting COS Compared With Daily COS: a Prospective Randomized Trial (clinicaltrials.gov) - P4 | N=110 | Completed | Sponsor: IRCCS San Raffaele | Active, not recruiting ➔ Completed

Trial completion • Infertility • Sexual Disorders

PE-PMA: Reduction of Progesterone Elevation at Trigger in POR After Long Acting COS Compared With Daily COS: a Prospective Randomized Trial (clinicaltrials.gov) - P4 | N=110 | Active, not recruiting | Sponsor: IRCCS San Raffaele | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Feb 2023 ➔ Apr 2024 | Trial primary completion date: Aug 2022 ➔ Feb 2024

Enrollment closed • Trial completion date • Trial primary completion date • 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: Jan 2024 ➔ Apr 2024

Trial initiation date

TROPIX: Usefulness of Corifollitropin α as Alternative to Conventional Daily rFSH Protocols in Oocyte Donors Undergoing Pituitary Suppression With Medroxiprogesterona Acetate (MPA) (clinicaltrials.gov) - P=N/A | N=318 | Not yet recruiting | Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

New trial • 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

New P4 trial

2-Shot: Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation. (clinicaltrials.gov) - P3 | N=194 | Recruiting | Sponsor: Fundación Santiago Dexeus Font | Not yet recruiting ➔ Recruiting

Enrollment open • Trial completion date • Trial primary completion date

Conventional ovarian stimulation vs. delayed single dose corifollitropin alfa ovarian stimulation in oocyte donors: a prospective randomized study. Tail trial. (PubMed, Front Reprod Health) - P4 | "No additional rFSH was administered in this group. Clinical Trial Registration: https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-001343-44/results."

Journal

ELONVA FLARE PROTOCOL: a new approach for poor responders in superovulation for In Vitro Fertilisation (IVF). (ANZCTR) - P1 | N=20 | Completed | Sponsor: UNSW | Not yet recruiting ➔ Completed

Trial completion • Gynecology • Infertility • Sexual Disorders

PHARMACOKINETICS OF OVARIAN STIMULATION FOR PROJECTED POOR RESPONDER PATIENTS IN IVF. A RANDOMISED TRIAL COMPARING A CORIFOLLITROPIN ALFA AGONIST FLARE PROTOCOL WITH A CORIFOLLITROPIN ALFA ANTAGONIST PROTOCOL (ASPIRE 2023) - No abstract available

Clinical • PK/PD data

Dosing Characteristics of Recombinant Human Luteinizing Hormone or Human Menopausal Gonadotrophin-Derived LH Activity in Patients Undergoing Ovarian Stimulation: A German Fertility Database Study. (PubMed, Gynecol Obstet Invest) - "The standard of care for OS cycles is described with respect to IVF/ICSI treatment including an LH component in Germany during the specified timeframe."

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

Low responders may benefit from undergoing ovarian stimulation with a long GnRH agonist protocol with corifollitropin alfa followed by hMG. (PubMed, JBRA Assist Reprod) - "Both simplified long protocol and GnRH antagonist protocol are suitable for low responders. The best second cycle clinical outcomes experienced in a population with worse prognosis (group 2) suggests that the simplified long protocol may be a better option, although prospective well-conducted studies must explore this hypothesis."

Journal

DUO_STIM_FRESH: Double Stimulation Followed by a Fresh Embryo Transfer (clinicaltrials.gov) - P4 | N=120 | Completed | Sponsor: Fundación Santiago Dexeus Font | Recruiting ➔ Completed | Trial primary completion date: Oct 2022 ➔ Jan 2023

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