Rekovelle (follitropin delta) / Ferring - LARVOL DELTA

EVALUATION OF FE 999049 DOSAGE SUITABILITY IN UNITED STATES (US) WOMEN UNDERGOING CONTROLLED OVARIAN STIMULATION, A RITA TRIAL ANALYSIS (ASRM 2025) - No abstract available

Clinical • Infertility • Sexual Disorders

CHARACTERIZATION OF FE 999049 TOLERABILITY IN UNITED STATES (US) WOMEN UNDERGOING CONTROLLED OVARIAN STIMULATION, A RITA TRIAL ANALYSIS (ASRM 2025) - No abstract available

Clinical • Infertility • Sexual Disorders

Impact of gonadotropin selection on risk of ovarian hyperstimulation syndrome in predicted high responders: a Menopur in Gonadotropin-releasing hormone Antagonist Single Embryo Transfer-High Responder trial analysis. (PubMed, F S Rep) - "To evaluate the risk of ovarian hyperstimulation syndrome (OHSS) with highly purified human menopausal gonadotropin (HP-hMG) or recombinant follicle-stimulating hormone (rFSH) for controlled ovarian stimulation in patients predicted to be high responders...Holding the number of oocytes constant, the odds of early OHSS in HP-hMG-treated subjects was 0.46 times (95% CI: 0.26, 0.82) that in rFSH-treated subjects. In predicted high-responder patients, HP-hMG stimulation was associated with significantly diminished OHSS rates compared with rFSH, adjusted for oocyte yield."

Journal • Infertility • Sexual Disorders

Celestial-1: An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta During Controlled Ovarian Stimulation (clinicaltrials.gov) - P1 | N=310 | Terminated | Sponsor: Ferring Pharmaceuticals | N=600 ➔ 310 | Trial completion date: Sep 2026 ➔ Sep 2025 | Recruiting ➔ Terminated | Trial primary completion date: Sep 2026 ➔ Sep 2025; This is a company decision made not related to safety concerns. Rather, it reflects a broader portfolio assessment and the desire to focus on programs that can bring timely and meaningful benefit to patients.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination

Celestial-2: An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta at Different Time Intervals During Controlled Ovarian Stimulation. (clinicaltrials.gov) - P1 | N=106 | Terminated | Sponsor: Ferring Pharmaceuticals | N=200 ➔ 106 | Trial completion date: Jul 2026 ➔ Sep 2025 | Recruiting ➔ Terminated | Trial primary completion date: May 2026 ➔ Sep 2025; This is a company decision made not related to safety concerns. Rather, it reflects a broader portfolio assessment and the desire to focus on programs that can bring timely and meaningful benefit to patients.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Infertility • Sexual Disorders

A multicentric real-world observational study to describe the use and efficacy of follitropin delta for IVF/ICSI procedures in patients at risk of hypo-response. (PubMed, Front Reprod Health) - "The results describe the real-world use of follitropin delta and demonstrate its suitability for POSEIDON group 3 and 4 patients. These data complement clinical trial outcomes, supporting clinician decision-making and improving IVF/ICSI outcomes."

Journal • Observational data • Real-world evidence

Effectiveness and safety of follitropin delta in routine clinical practice in the Nordics and Switzerland (the NORSOS study): a prospective non-interventional study. (PubMed, Front Endocrinol (Lausanne)) - P | "Almost all women (190/193, 98.4%) expressed satisfaction with the injection pen. The NORSOS study (NCT05499052) provides insights into the use of follitropin delta in routine clinical practice and complements previous evidence regarding its effectiveness and safety profile."

Journal • Observational data • Gynecology • Infertility • Sexual Disorders

Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE) (clinicaltrials.gov) - P2 | N=80 | Not yet recruiting | Sponsor: Centre Hospitalier Intercommunal Creteil

New P2 trial • Infertility • Sexual Disorders

A retrospective cohort study describing the real-world use of follitropin delta for ovulation induction (prior to intrauterine insemination or frozen embryo transfer) in Australia (ANZCTR) - P=N/A | N=200 | Active, not recruiting | Sponsor: Ferring

New trial • Real-world evidence • Infertility • Sexual Disorders

MARCS 2: Menopur And Rekovelle Combination Study Version 2.0 (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Clinique Ovo | Not yet recruiting ➔ Recruiting

Enrollment open

Aurora Test for ART Donor Patients (AURORA-Donor) (clinicaltrials.gov) - P=N/A | N=160 | Recruiting | Sponsor: Fertiga, Belgium | Trial completion date: Sep 2025 ➔ Sep 2026 | Trial primary completion date: Apr 2025 ➔ Apr 2026

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

REKOVELLE PEN for S.C. Injection General Drug Use Survey (Controlled Ovarian Stimulation in Assisted Reproductive Technologies) (clinicaltrials.gov) - P=N/A | N=500 | Recruiting | Sponsor: Ferring Pharmaceuticals | Trial primary completion date: Apr 2025 ➔ Feb 2026

Trial primary completion date • Infertility • Sexual Disorders

Ovarian stimulation with follitropin delta is safe and effective: Results from the RITA randomized, double-blind, placebo-controlled trials. (PubMed, Fertil Steril) - P3 | "Follitropin delta, dosed based on maternal age, is an effective and safe therapeutic for ovarian stimulation in IVF/ICSI patients."

Clinical • Journal • Gynecology

Ovarian stimulation with follitropin delta for in vitro fertilization: a multicentre, randomized, assessor-blind comparison with follitropin alfa using conventional dosing regimens (ADAPT-1 trial). (PubMed, Hum Reprod) - P3 | "Treatment groups had similar ovarian responses, supporting equivalence for starting doses follitropin delta 15 µg and follitropin alfa 225 IU, with low rates of early OHSS. Ovarian stimulation cycles with follitropin delta in µg can be planned and adjusted, leveraging the established IU dose equivalence to follitropin alfa."

Journal • Preclinical • Gynecology • Infertility • Obstetrics • Sexual Disorders

A randomised, controlled, assessor-blind, parallel groups, multicentre trial comparing the ovarian response of a starting dose of either 10 μg or 15 μg follitropin delta (FE 999049) to a starting dose (ChiCTR) - P3 | N=300 | Recruiting | Sponsor: The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University

New P3 trial • Gynecology

LYCHEE: To Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patterns of Use in Real-world Practice (clinicaltrials.gov) - P=N/A | N=2500 | Not yet recruiting | Sponsor: Ferring Pharmaceuticals

New trial • Real-world evidence • Infertility • Sexual Disorders

One-year cumulative live birth rate associated with the number of oocytes in ovarian stimulation with follitropin delta: a pooled analysis of four randomized controlled trials. (PubMed, Hum Reprod) - "This analysis suggests an increase in CLBR with the number of oocytes retrieved up to a plateau starting at 21-25 oocytes following ovarian stimulation cycles with follitropin delta and subsequent frozen cycles. An increase in CLBR from 20 oocytes was evident in older but not in younger patients."

Journal • Retrospective data

COCO: A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China (clinicaltrials.gov) - P3 | N=301 | Completed | Sponsor: Ferring Pharmaceuticals | Active, not recruiting ➔ Completed | Trial completion date: Nov 2025 ➔ May 2025 | Trial primary completion date: Nov 2025 ➔ May 2025

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

MARCS 2: Menopur And Rekovelle Combination Study Version 2.0 (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Clinique Ovo

New P2 trial

Cost-Effectiveness of Follitropin Delta versus Follitropin Alfa in Controlled Ovarian Stimulation for IVF/ICSI Cycles in China (ISPOR 2025) - "Rekovelle is cost-effective compared with Gonal-f in COS for IVF/ICSI cycles in China. This is attributed to improved OP and LB rates with a lower total dose of FSH."

Cost effectiveness • HEOR

Real-world Evidence on Follitropin Delta Individual Dosing (clinicaltrials.gov) - P=N/A | N=850 | Recruiting | Sponsor: University of Luebeck | Trial completion date: Dec 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2024 ➔ Mar 2026

Trial completion date • Trial primary completion date • 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

Follicle-stimulating hormone stimulates free radical generation without inducing substantial oxidative stress in human granulosa cells. (PubMed, Hum Reprod Open) - "We demonstrate that FSH of both physiological and supraphysiological concentrations induces free radical generation at subcellular levels, most notably in the mitochondria, while the elevated free radical load causes neglectable oxidative damage in both cGCs and mGCs. Our results suggest that the 'FSH Ootoxicity' hypothesis would not seem to be mediated by ROS in human GCs."

Journal • Infertility • Sexual Disorders

COCO: A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 Μg or 15 Μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China (clinicaltrials.gov) - P3 | N=300 | Active, not recruiting | Sponsor: Ferring Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Infertility • Sexual Disorders

Controlled ovarian stimulation (COS) with follitropin delta results in higher cumulative live birth rates compared with follitropin alfa/beta in a large retrospectively analyzed real-world data set. (PubMed, Reprod Biol Endocrinol) - "In this large retrospective analysis of a prospectively collected real-world data set, the higher cumulative LBR with hrFSH compared to rFSH supports the use of an individualized fertility treatment approach based on hrFSH."

Journal • Real-world evidence • Retrospective data