Elonva (corifollitropin alfa) / Organon - LARVOL DELTA

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

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

Corifollitropin alfa N02 versus recombinant FSH for ovarian stimulation: a phase 3 trial and safety study in Chinese women. (PubMed, Reprod Biomed Online) - P3 | "A single dose of corifollitropin alfa N02 was non-inferior to daily rFSH in terms of oocyte yield, with similar safety, offering a simplified ovarian stimulation alternative for Chinese women with a normal ovarian reserve."

Journal • P3 data

2-Shot: Comparison of Sequential CFA vs CFA +rFSH for Elective Fertility Preservation. (clinicaltrials.gov) - P3 | N=194 | Completed | Sponsor: Fundación Santiago Dexeus Font | Recruiting ➔ Completed | Trial completion date: Jan 2026 ➔ Sep 2025

Trial completion • Trial completion date

2304-VLC-051-JG: Usefulness of Corifollitropin alfa as alternative to conventional daily rFSH protocols in oocyte donors undergoing pituitary suppression with Medroxiprogesterona acetate (MPA). (clinicaltrialsregister.eu) - P2/3 | N=130 | Recruiting | Sponsor: Ivi Valencia S.L. | N=318 ➔ 130

Enrollment change • Gynecology • Infertility • Sexual Disorders

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 | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Apr 2026 ➔ Apr 2027

Trial completion date • Trial primary completion date

An injection-lite approach to ovarian stimulation in poor responder patients using corifollitropin alfa and nasal GnRH agonist. (PubMed, J Assist Reprod Genet) - "The CFA flare protocol is a novel alternative to conventional ovarian stimulation regimens that are used for 'poor responder' patients. It significantly reduces the patient burden, with less injections of FSH and no injections of GnRH antagonist. The ovarian response is similar to that achieved with a conventional GnRH antagonist cycle, but this requires further evaluation in a larger study."

Journal

Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART) (clinicaltrials.gov) - P=N/A | N=200 | Not yet recruiting | Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.

New trial • Infertility • Sexual Disorders

Gonadotrophin type and antral follicle count-adjusted follicular recruitment and oocyte yield in 4525 antagonist cycles. (PubMed, Reprod Biomed Online) - "After adjusting for AFC, CFA achieved the highest FORT and FOI across most AMH strata, consistently outperforming HP-HMG and matching or exceeding rFSH, while maintaining the lowest follicle-count-based OHSS risk."

Journal

Influence of corifollitropin alfa on embryo morphokinetics and fertility treatment outcome. (PubMed, Front Reprod Health) - "Despite differences in baseline patient characteristics, CFA was associated with comparable embryo developmental dynamics and live birth outcomes compared with daily follitropin β stimulation. These findings suggest that CFA may represent an alternative COS strategy in routine clinical practice without apparent detrimental effects on early embryo development; however, they should be interpreted with caution due to the observational design."

Journal • Gynecology

Preconception Nutraceutical Intervention Optimizes Ovulation Induction Outcomes in Women with Polycystic Ovary Syndrome (ISGE 2026) - "Patients were stratified into two groups: Group 1 (n = 76) received preconception therapy comprising FT 500 Plus (inositol 2000 mg, folic acid 400 µg, glutathione 50 mg, lutein 3 mg, zinc 10 mg, vitamins C 160 mg and E 12 mg, selenium 55 µg) and vitamin D3 (Aquadetrim, 2 drops 2–3× daily) for 2–3 months; Group 2 (n = 70) received folic acid alone. All participants underwent COS with corifollitropin alfa, recombinant FSH, GnRH antagonist, and GnRH agonist trigger... Preconception supplementation with inositol, antioxidants, and vitamin D3 modulates endocrine and metabolic milieu, augments oocyte developmental competence, and improves embryological and clinical outcomes in PCOS patients undergoing IVF. Individualized COS protocols incorporating targeted preconception therapy enhance ART efficacy and safety."

Clinical • Endocrine Disorders • Infertility • Metabolic Disorders • Polycystic Ovary Syndrome • Sexual Disorders

Risk of progesterone elevation in patients with low ovarian reserve using long-acting FSH IVF protocol: a randomized controlled trial. (PubMed, Reprod Biomed Online) - "Ovarian stimulation with long-acting CFA plus daily 150 IU r-FSH significantly reduced the risk of PPE and increased the feasibility of fresh embryo transfer in patients with low ovarian reserve. This strategy may offer a better approach for managing PPE, and may improve overall IVF success for this specific patient population."

Journal

PPOS (Progestin Primed Ovarian Stimulation) and Corifollitropin Alfa (CFA) Cross-over Study (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: Steven Weyers, MD, PhD | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: May 2025 ➔ Dec 2027

Enrollment open • Trial completion date • Trial primary completion date

Feasibility and efficacy of random-start progestin-primed ovarian stimulation: a multicenter pilot randomized controlled trial in oocyte donation. (PubMed, Reprod Biol Endocrinol) - No abstract available

Journal

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 | Initiation date: Jul 2025 ➔ Dec 2025

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 | Recruiting | Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA | Not yet recruiting ➔ Recruiting

Enrollment open • Infertility • Sexual Disorders

A single dose of corifollitropin alfa is equipotent to a daily dose of 300 IU recombinant FSH regardless of ovarian reserve. (PubMed, Reprod Biomed Online) - "Regardless of ovarian reserve, a single dose of CFA provides a similar ovarian response as daily 300 IU recFSH in patients undergoing IVF/intracytoplasmic sperm injection."

Journal

Etonogestrel implant for LH suppression in a novel DuoStim ovarian stimulation protocol using overlapping doses of corifollitropin alfa for social egg freezing: a case report. (PubMed, JBRA Assist Reprod) - "Our report is the first to highlight that a woman attempting fertility preservation while using an ENG implant for contraception may benefit from LH suppression during COS. Additionally, it proposes a novel protocol that applies CFA in overlapping doses, aiming for comfort and lower cost."

Journal • Women's Health

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 | Initiation date: Apr 2025 ➔ Jul 2025

Trial initiation date

Continuous Double Ovarian Stimulation. (clinicaltrials.gov) - P4 | N=30 | Completed | Sponsor: Instituto Bernabeu | Recruiting ➔ Completed

Trial completion

The efficacy of intraovarian versus subcutaneous corifollitropin alfa administration in DuoStim protocol for infertile women with low in vitro fertilization response. (PubMed, J Obstet Gynaecol Res) - "The study revealed that intraovarian injection of corifollitropin alfa may enhance the quality of oocytes retrieved, particularly Grade B oocytes, in women with poor response to IVF under the DuoStim protocol, while both methods exhibited similar outcomes in terms of demographic factors, cycle duration, and gonadotropin dosage."

Clinical • Journal • Preclinical • Gynecology • Infertility • Sexual Disorders

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