Rekovelle (follitropin delta) / Ferring - LARVOL DELTA

Ovulation Trigger Strategies in Low Ovarian Reserve (TRIGGERBEST) (clinicaltrials.gov) - P3 | N=126 | Recruiting | Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia

New P3 trial • Gynecology

Efficacy of follitropin delta in potential low responders: a pooled analysis of individual patient data from five randomized controlled trials. (PubMed, Front Endocrinol (Lausanne)) - "This pooled analysis adds evidence for the efficacy of follitropin delta across all ovarian reserve subgroups of the infertile population. The study was limited to fresh cycle outcomes; further studies are warranted focusing on cumulative outcomes and older patient populations with low ovarian reserve."

Journal • Retrospective data • Infertility

INOVEE: INtensity of OVarian Stimualtion and Euploid Embryos (clinicaltrials.gov) - P4 | N=110 | Recruiting | Sponsor: Fundación Santiago Dexeus Font | Trial completion date: May 2026 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date

REKOVELLE PEN for S.C. Injection General Drug Use Survey (Controlled Ovarian Stimulation in Assisted Reproductive Technologies) (clinicaltrials.gov) - P=N/A | N=571 | Completed | Sponsor: Ferring Pharmaceuticals | Recruiting ➔ Completed | Trial completion date: Jun 2029 ➔ Feb 2026

Trial completion • Trial completion date • Infertility • Sexual Disorders

EQUAM: Embryo QUAlity in Ovarian Stimulation With hMG. (clinicaltrials.gov) - P4 | N=240 | Not yet recruiting | Sponsor: Fundacion Dexeus

New P4 trial • Infertility • Sexual Disorders

FSD-QUA-2025-27: The impact of ovarian stimulation with hMG on embryo quality in advanced age women. A randomized controlled trial (clinicaltrialsregister.eu) - P4 | N=240 | Not yet recruiting | Sponsor: Santiago Dexeus Font Fundacio Privada

New P4 trial • Infertility • Sexual Disorders

Follitropin Beta as a Rescue Protocol for Poor Responders to Follitropin Delta: A Retrospective Within-Patient Paired Study. (PubMed, Cureus) - "In patients who respond poorly to follitropin delta, alternative gonadotropins permitting higher dose administration, such as follitropin beta (Follistim®), may be considered...Methods This retrospective, single-center, within-patient paired study included patients who underwent follitropin delta antagonist-protocol cycles with letrozole co-administration and were subsequently switched to follitropin beta with letrozole co-administration due to poor ovarian response between January 2024 and April 2026...These exploratory findings do not constitute evidence of a treatment benefit but may serve as a basis for hypothesis generation. Larger prospective studies are warranted."

Journal • Retrospective data • Infertility • Sexual Disorders • KEAP1

U.S. REAL-WORLD PRESCRIBING PATTERNS OF MIXED GONADOTROPIN OVARIAN STIMULATION PROTOCOLS: A CLAIMS-BASED ANALYSIS (ISPOR 2026) - "Mixed ovarian stimulation protocols combining highly purified human menopausal gonadotropin (HP-hMG; menotropin, 1:1 FSH:LH bioactivity) with recombinant follicle-stimulating hormone (rFSH) are widely used, yet longitudinal data describing prescribing trends and relative FSH and LH bioactivity exposure are sparse. U.S. prescription claims demonstrate that mixed ovarian stimulation protocols combining menotropin and rFSH predominate and continue to increase over time. Prescribed vial patterns consistently reflect greater relative FSH compared with LH bioactivity (~3:1), highlighting clinician preferences in mixed-protocol design. Mixed-protocol utilization may be underestimated, as cycles paid fully out-of-pocket are not captured in claims data."

Clinical • Real-world • Real-world evidence

REAL-WORLD INSIGHTS ON CONTROLLED OVARIAN STIMULATION FOR IVF/ICSI: DATA FROM A LARGE FERTILITY EMR DATABASE IN THE US (2010 - 2024) (ISPOR 2026) - "Mixed gonadotropin protocols combining highly purified human menopausal gonadotropin (HP-hMG, with a 1:1 FSH:LH bioactivity ratio) and recombinant FSH (rFSH) accounted for 88% of cycles, compared with rFSH monotherapy (8%) and HP-hMG monotherapy (4%). U.S. IVF/ICSI practice is dominated by mixed HP-hMG and rFSH protocols, with the most common total FSH:LH bioactivity ratio of approximately 3:1. This analysis provides the first large-scale characterization of gonadotropin starting doses and FSH:LH ratios in U.S. clinical practice and offers evidence to support more standardized and efficient ovarian stimulation strategies in the future."

Clinical • Real-world • Real-world evidence • Infertility • Sexual Disorders

Cost-Effectiveness of Follitropin Delta Compared with Follitropins Alfa and Beta in Controlled Ovarian Stimulation for Assisted Reproductive Technologies (ART) in France. (PubMed, Pharmacoecon Open) - P3 | "Follitropin delta provides an effective alternative to follitropin alfa and beta with a potential cost-savings opportunity, excluding the delivery cost, due to higher OP and LB rates in the fresh cycle transfers."

HEOR • Journal • Gynecology • KEAP1

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 | Active, not recruiting | Sponsor: Ferring Pharmaceuticals | Recruiting ➔ Active, not recruiting

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

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

Enrollment open • Real-world evidence • 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 | Recruiting | Sponsor: Centre Hospitalier Intercommunal Creteil | Trial completion date: Dec 2027 ➔ Mar 2028 | Trial primary completion date: Jun 2027 ➔ Dec 2027

Trial completion date • Trial primary completion date • 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 | Recruiting | Sponsor: Centre Hospitalier Intercommunal Creteil | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2025 ➔ Dec 2025

Enrollment open • Trial initiation date • Infertility • Sexual Disorders

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