Rekovelle (follitropin delta) / Ferring - LARVOL DELTA

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

Oocyte yield and live birth rate after follitropin delta dosing and fresh embryo transfer: an individual patient data meta-analysis. (PubMed, Reprod Biomed Online) - "After ovarian stimulation with individualized follitropin delta, LBR in fresh transfer cycles was highest for patients with 8-14 oocytes retrieved, and peaked in patients with 11 oocytes retrieved. The results support the appropriateness of the follitropin delta dosing algorithm."

Clinical • Journal • Retrospective data

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=600 | Recruiting | Sponsor: Ferring Pharmaceuticals | Trial completion date: Sep 2027 ➔ Sep 2026

Trial completion date

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

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

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

Patient preferences on pen injectors for assisted reproductive technology: a discrete choice experiment in France. (PubMed, Expert Opin Drug Deliv) - "Estimation of the utilities showed statistically significant difference in favor of Gonal-f®/Pergoveris® (reference modalities) versus other pens, and the largest difference was with Rekovelle® [95% CI:-1,37;-0.85], and Bemfola® [95% CI:-2.25;-1,52]. This study show that respondent preferred pen that are ready to use, can be used multiple times, have dose injection confirmation, and display the dose with digits."

Journal • Infertility • Sexual Disorders

Follitropin Delta Is Cost-Effective Versus Follitropins Alfa and Beta in Controlled Ovarian Stimulation for Assisted Reproductive Technologies (ART) in France (ISPOR-EU 2024) - "Follitropin delta is cost-effective compared with follitropins alfa and beta in ART for women undergoing COS protocols from French health care perspective. This is attributed to improved OP and LB rates."

Cost effectiveness • HEOR • KEAP1

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."

FOLLITROPIN DELTA (REKOVELLE®) IN GROUP 3 AND 4 POSEIDON PATIENTS UNDERGOING IVF/ICSI FOR IN VITRO FERTILIZATION : IS ANTAGONIST PROTOCOL THE BEST? (ASRM 2024) - "SUPPORT no OBJECTIVE Our aim is to evaluate, in IVF/ICSI for women with poor ovarian reserve, in both antagonist and agonist luteal phases gonadotropin-releasing hormone protocols, the stimulation parameters with a controlled ovarian stimulation with follitropin delta, mixed or not with highly purified human menopausal gonadotropin HP-hMG. Luteal agonist protocol may be used for Groups 3 and 4 POSEIDON patients without any statistical difference in terms of pregnancy rate. Nevertheless, Antagonist mixed protocol seems better in this population."

Preclinical • Gynecology

A Trial to Compare Efficacy and Safety of Follitropin Delta Versus Placebo (Inactive Treatment) in the Treatment of Men With Idiopathic Infertility (Unexplained Reduction of Semen Quality) (ADAM) (clinicaltrials.gov) - P2 | N=4 | Terminated | Sponsor: Ferring Pharmaceuticals | N=400 ➔ 4 | Trial completion date: Jul 2026 ➔ Oct 2024 | Recruiting ➔ Terminated | Trial primary completion date: Jul 2026 ➔ Oct 2024; The probability of enrolling subjects in the trial in a reasonable timeframe was too low. The termination was not due to safety concerns nor changes in Ferring's Reproductive Medicine strategy or interest in developing treatments for Male Infertility

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

PROFOUND: Prospective, Multi-centre, Non-Interventional Study to Investigate the Effectiveness of REKOVELLE® for Ovarian Stimulation for Asian Women in Real World Settings (clinicaltrials.gov) - P=N/A | N=1500 | Recruiting | Sponsor: Ferring Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Real-world • Real-world evidence • Infertility • Sexual Disorders

PROFOUND: Prospective, Multi-centre, Non-Interventional Study to Investigate the Effectiveness of REKOVELLE® for Ovarian Stimulation for Asian Women in Real World Settings (clinicaltrials.gov) - P=N/A | N=1500 | Not yet recruiting | Sponsor: Ferring Pharmaceuticals

New trial • Real-world • Real-world evidence • 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

New trial • Infertility • Sexual Disorders

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=200 | Recruiting | Sponsor: Ferring Pharmaceuticals

New P1 trial • Infertility • Sexual Disorders

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

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=600 | Recruiting | Sponsor: Ferring Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open