The goal of this clinical trial is to evaluate the safety and effectiveness of a personalized ovarian stimulation regimen in women aged 18 to 40 undergoing in vitro fertilization (IVF). The main question it aims to answer is:
- Does personalizing the starting doses of follitropin delta (REKOVELLE) and HP-hMG (MENOPUR) based on both age and body lead to similar results as anti-Müllerian hormone (AMH) and weight based dosing ?
Researchers will compare the new dosing regimen to the MARCS study results to see if this new approach leads to similar outcomes
Participants will:
* Receive ovarian stimulation using a personalized dose of REKOVELLE aND MENOPUR based on age and weight
* Be monitored through ultrasound imaging and blood tests to measure estradiol (E2) levels
* Undergo standard IVF procedures including egg retrieval and embryo assessment

Start Date04 Jul 2025

Sponsor / Collaborator

Clinique Ovo, Inc.

[+1]

NCT06561958

/ RecruitingNot Applicable

Prospective, Multi-country, Non-Interventional Study to Investigate REKOVELLE for Ovarian Stimulation: the Effectiveness, Safety, and Patterns Of Use for Asian Women in Real World Practice

Primary objective is to investigate the effectiveness of REKOVELLE® in women undergoing their first REKOVELLE® ovarian stimulation treatment in real world practice in Asian countries.

Start Date27 Aug 2024

Sponsor / Collaborator

Ferring Pharmaceuticals SA

NCT06511791

/ RecruitingPhase 1

A Randomised, Double-blind, Placebo-controlled, Parallel-group Exploratory Trial to Investigate the Effect of FE 999302 When Administered During Different Time Intervals in Women Undergoing Controlled Ovarian Stimulation With a Fixed Dose of Follitropin Delta in a Gonadotropin-releasing Hormone Antagonist Protocol.

This is a phase 1b clinical trial with Choriogonadotropin beta (FE999302) and Follitropin delta (Rekovelle). The trial is a randomised, double blind, placebo controlled, parallel group, exploratory trial, investigating the effect of FE 999302 when administered during different time intervals in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a antagonist protocol.

Start Date15 Jul 2024

Sponsor / Collaborator

Ferring Pharmaceuticals SA

100 Clinical Results associated with Follitropin delta

100 Translational Medicine associated with Follitropin delta

100 Patents (Medical) associated with Follitropin delta

1,199

Literatures (Medical) associated with Follitropin delta

01 Sep 2025·THERIOGENOLOGY

Single-dose recombinant FSH as a viable alternative to multi-dose porcine FSH in commercial superovulation protocols in cows

Article

Author: Rovani, Monique Tomazele ; Ferreira, Rogério ; Hênryli de Souza, Alexandre ; Bordignon, Vilceu ; Frata, Monique Mazzarollo ; Dias Gonçalves, Paulo Bayard ; Mondadori, Rafael Gianella ; Gasperin, Bernardo Garziera ; Marques de Lima, Wagner

Superovulation (SOV) for embryo transfer (ET) typically requires eight decreasing doses of porcine FSH (pFSH) due to the short half-life. Recently, a recombinant FSH (rFSH) formulation has become available, allowing for SOV with a single treatment. This study aimed to compare the outcomes of SOV in commercial ET programs using eight doses of pFSH versus a single administration of rFSH. Data from 569 SOV procedures conducted under commercial conditions with pFSH (n = 291) or rFSH (n = 278) were evaluated. No significant differences were observed regarding the total number of recovered structures (TS), degenerated embryos (DG), and transferable embryos (TE). However, the number and proportion of unfertilized oocytes (UF) relative to TS were higher in the rFSH group. Conversely, the proportion of DG relative to TS was higher in the pFSH group. The proportion of TE relative to TS was consistent at 60 % for both treatments. Finally, when a small subset of cows (n = 12) were SOV four times with rFSH at 40- to 60-day intervals, no significant differences were observed in TS or TE. In conclusion, a single administration of rFSH provides SOV outcomes comparable to those achieved with eight administrations of pFSH in commercial ET programs and results seem constant across repeated treatments with rFSH.

01 Aug 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Development and characterisation of a method for determining N-terminal heterogeneity in the human recombinant follitropin β-subunit

Article

Author: Zhang, Xiaoming ; Liang, Chenggang ; Sun, Yue ; Lv, Ping ; Li, Yi ; Hu, Xinyue ; Wang, Lvyin ; Li, Jing ; Han, Xuezhi

Recombinant human follicle-stimulating hormone (rhFSH) consists of α- and β subunits linked by non-covalent bonds. Both subunits exhibit N-terminal heterogeneity, with the β-subunit exhibiting heterogeneity to a greater extent. In this study, we developed a comprehensive method for assessing β-subunit N-terminal heterogeneity based on a previously developed peptide mapping approach. The new method, which includes optimised sample preparation and reversed-phase high-performance liquid chromatography, facilitated the separation of integrated (NSCELTNITIAIEK) βL1 and truncated (CELTNITIAIEK) βL1 forms. The identity of the separated integrated and truncated forms was confirmed via tandem mass spectrometry. Optimised sample preparation streamlined the process by simultaneously performing trypsin digestion (with calcium chloride enhancement) and PNGase F deglycosylation for a total preparation time of just 1 day. The enzymatic digestion and sample preparation processes underwent several evaluations, including scaled-up sample preparation, sample preparation variability assessment and extended incubation stability studies. The sample preparation process demonstrated excellent robustness in all evaluations. Results consistently showed approximately 50 % N-terminal truncation of two amino acids in the β-subunit across different manufacturers' samples, highlighting the utility of the method in assessing the batch-to-batch consistency and comparability of biosimilar products. This integrated approach combines peptide mapping and N-terminal heterogeneity analysis into a single, efficient workflow, thereby significantly enhancing quality control processes and enhancing the safety and efficacy of recombinant FSH products.

01 Aug 2025·HUMAN REPRODUCTION

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

Article

Author: Falahati, Ali ; Santos-Ribeiro, Samuel ; Macklon, Nick S ; Jepsen, Ida E ; Pinborg, Anja ; Lobo, Rita ; Moley, Kelle

Abstract:

STUDY QUESTION:

What number of oocytes retrieved is associated with the highest cumulative live birth rates (CLBRs) in the fresh and subsequent frozen cycles following ovarian stimulation with follitropin delta?

SUMMARY ANSWER:

The CLBR increased with the number of oocytes retrieved, plateauing at 21–25 oocytes.

WHAT IS KNOWN ALREADY:

Live birth rate (LBR) per fresh cycle is the conventionally reported outcome of IVF; however, the marked increase in cryopreserved cycles in recent years suggests that the CLBR has emerged as a more relevant outcome. In the fresh cycle, the number of oocytes retrieved is regarded as a prognostic factor for LBR, and a similar association has been shown for CLBR.

STUDY DESIGN, SIZE, DURATION:

Pooled analysis including 1746 patients from four randomized controlled trials. Trials were identified from clinical trials available in the Ferring Pharmaceuticals database up to June 2023. Selected trials used follitropin delta for ovarian stimulation and collected outcome data from both fresh and frozen cycles. Follitropin delta dose–response trials, as well as trials investigating follitropin delta in repeated ovarian stimulation cycles, were excluded. Patients included in the analysis underwent ovarian stimulation with follitropin delta and had at least one oocyte retrieved. The outcome of CLBR in the fresh and subsequent frozen cycles was evaluated in relation to the number of oocytes retrieved. CLBR was calculated as the number of patients with at least one live birth divided by the number of all patients included in the analysis.

PARTICIPANTS/MATERIALS, SETTING, METHODS:

Trial participants were women, 18–42 years of age, who were undergoing their first or second IVF/ICSI cycle in a GnRH antagonist/agonist protocol. Triggering was performed with hCG or GnRH agonist, and insemination was performed by IVF or ICSI. Single or double blastocyst transfer was performed on Day 5 in the fresh cycle, and all viable surplus blastocysts were cryopreserved on Day 5 or Day 6. All pregnancies from the fresh cycle and frozen cycles initiated within 1 year after the start of stimulation were followed until birth. The association between the number of oocytes retrieved and CLBR was assessed using a logistic regression analysis with fractional polynomials to obtain predicted CLBR. Subgroup analyses were performed based on age, anti-Müllerian hormone (AMH), and number of oocytes retrieved.

MAIN RESULTS AND THE ROLE OF CHANCE:

Overall, 15 trials with follitropin delta were identified in the database. Of those, 11 trials were not eligible, and the remaining 4 trials were included. In total, 1746 patients were included in the analysis. The mean age was 33.8 years (range 21–42 years), and the median AMH level was 17.0 pmol/l (range 0.3–164.2 pmol/l). The vast majority of patients (1645 patients, 94.2%) were treated with a GnRH antagonist protocol, while 101 patients (5.8%) were treated with a GnRH agonist protocol. Overall, 1541 patients (88.3%) received hCG triggering, and 205 patients (11.7%) received GnRH agonist triggering. Frozen cycles (maximum of six) were initiated by 740 patients (42.4%). The study population underwent a total of 2948 cycles: 1746 fresh cycles (referring to ovarian stimulation cycles, with or without transfer) and 1202 frozen cycles (initiated cycles, with or without transfer). The mean number of oocytes retrieved was 12.4 (range 1–72), the fresh cycle LBR was 29.1%, and the CLBR was 51.4%. The CLBR increased with the number of oocytes retrieved up to a plateau starting at 21–25 oocytes. The CLBR reached above 60% at >15 oocytes and above 70% at >20 oocytes. The CLBR decreased with increasing age (57.1%, 51.6%, and 35.8% at <35, 35–37, and ≥38 years), while it was similar for AMH <15 and ≥15 pmol/l (52.0% and 50.9%, respectively). A continued increase in predicted CLBR from 15 oocytes retrieved was observed in older patients (≥38 years); from 41.3% to 53.4% to 58.7% at 15–19, 20–24, and ≥25 oocytes. No equivalent benefit was observed in younger patients (<38 years), where corresponding rates were 72.5%, 68.0%, and 78.8% in patients <35 years and 70.3%, 73.1%, and 71.5% in patients 35–37 years. The fresh cycle LBR decreased beyond 14 oocytes, while the CLBR continued to increase by the number of oocytes retrieved.

LIMITATIONS, REASONS FOR CAUTION:

A limited number of patients included in the analysis had ≥20 oocytes retrieved (249 patients, 14.3%).

WIDER IMPLICATIONS OF THE FINDINGS:

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.

STUDY FUNDING/COMPETING INTEREST(S):

The study was funded by Ferring Pharmaceuticals A/S, Copenhagen, Denmark. S.S.-R. has received research funding from Organon/MSD, Theramex, and Gedeon-Richter, consulting fees from Organon/MSD, Ferring Pharmaceuticals, Merck Serono, and IBSA, payment or honoraria from Organon/MSD, Besins and Gedeon-Richter, support for attending meetings from Gedeon-Richter and Besins, is an advisory board member for TTRANSPORT and Deputy of the ESHRE SQART SIG, and owns stocks of IVI Lisboa, Clinica de Reprodução assistida Lda. A.P. has received grants from Cryos, grants and payments from Gedeon Richter, Ferring Pharmaceuticals and Merck A/S, payments from Organon, consulting fees from IBSA, Ferring Pharmaceuticals, Gedeon Richter, Cryos, and Merck A/S, and travel support from Gedeon Richter. N.S.M. has received speaker and consultancy fees from Ferring Pharmaceuticals, IBSA, Merck, Freya, and Gedeon Richter, and is a shareholder in Verso Biosense. K.M. has been a scientific advisor for Calla Lily Clinical Care, Evvy, and AutoIVF. R.L., A.F., K.M., and I.E.J. are employees of Ferring Pharmaceuticals.

REGISTRATION NUMBER:

N/A.

News (Medical) associated with Follitropin delta

02 Jul 2025

·pipelinereview.com

Ferring ADAPT-1 Trial Builds on Dosing Evidence for Follitropin Delta

PARIS, France I July 02, 2025 I Follitropin delta starting dose of 15 micrograms (µg)/day has comparable efficacy and safety as a starting dose of 225 International Units (IU)/day of follitropin alfa for ovarian stimulation in vitro fertilisation (IVF)/intracytoplasmic sperm injection (ICSI) gonadotrophin-releasing hormone (GnRH) antagonist protocol cycles. This is the key finding of a trial presented today at the European Society of Human Reproduction and Embryology (ESHRE) Congress in Paris and published in Human Reproduction . These data build on previous studies which have established an estimated point of clinical correspondence for 10 µg follitropin delta to 150 IU follitropin alfa in this class of medications. 1,2 The ADAPT-1 trial was a multicentre, randomised, assessor-blind study involving 300 women aged 18-40 years undergoing IVF or ICSI. 3 The trial compared the efficacy and safety of follitropin delta and follitropin alfa using conventional dosing regimens with a primary endpoint of number of oocytes retrieved. Currently, follitropin delta is approved for use via a dosing algorithm based on serum anti-Müllerian Hormone (AMH) and bodyweight individualised for each patient, and aims to obtain an ovarian response which is associated with a favourable safety/efficacy profile. The clinical value of this approach has been well established 4,5,6,7,8 , particularly in treatment-naïve patients where the algorithm aims to achieve 8–14 retrieved oocytes while minimising the risk of ovarian hyperstimulation syndrome (OHSS) to optimise the live birth rate in a fresh and frozen transfer cycle. 4,5,6,7,8 Key Findings: Dr Andrea Bernabeu, Medical Director at Instituto Bernabeu and principal investigator of the ADAPT-1 trial, said: “No patients we see as fertility doctors are the same and the ability to optimise therapy based on patients age, treatment goal and whether they have a high or low response to follicular stimulation are all relevant. These data provide confidence and expand our understanding for dosing in follitropin delta.” Pierre-Yves Berclaz, Chief Science and Medical Officer at Ferring Pharmaceuticals, stated: “The ADAPT-1 trial results confirm the efficacy and safety of follitropin delta across the full range of dosing strategies, making it the only recombinant FSH with robust clinical evidence supporting multiple dosing strategies. Ferring will take forward the implications of this study in future dialogue with regulatory authorities.” About GnRH protocols Gonadotrophin-releasing hormone (GnRH) agonists and antagonists are used as concomitant treatment during ovarian stimulation to prevent premature luteinisation and ovulation for IVF/ICSI. 7,8 About Follitropin Delta (Rekovelle ® ) Follitropin delta is a human cell line-derived rFSH with an approved dosing algorithm designed for a predictable ovarian response. 3 It is the first rFSH derived from a human cell line (PER.C6 ® cell line). Follitropin delta is structurally and biochemically distinct from other existing rFSH gonadotrophins. 3,4 Follitropin delta is approved in certain markets for use in controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as IVF or ICSI cycle. The individualised dosing of follitropin delta is determined using an approved algorithm, based on a woman’s AMH level and body weight. 3,5 AMH is a biomarker used to assess ovarian reserve and can help predict ovarian response. 5,6 The follitropin delta dose should be based on AMH level, measured using the ELECSYS AMH Plus immunoassay from Roche, the ACCESS AMH Advanced from Beckman Coulter, or LUMIPULSE G AMH from Fujirebio. 3 About Ferring Pharmaceuticals Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine with a strong heritage in areas of gastroenterology and urology, and are at the forefront of innovation in uro-oncology gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which market its medicines in over 100 countries. Learn more at www.ferring.com , or connect with us on LinkedIn , Instagram , YouTube , Facebook and X . REFERENCES 1 – Arce JC, Larsson P, Garcia-Velasco JA; Establishing the follitropin delta dose that provides a comparable ovarian response to 150 IU/day follitropin alfa; RBMO; 2020 2 – Yang R, Zhang Y, Liang X et al; Comparative clinical outcome following individualized follitropin delta dosing in Chinese women undergoing ovarian stimulation for in vitro fertilization / intracytoplasmic sperm injection; Reproductive Biology and Endocrinology; 2022 3 – Clinical Trials.gov page: https://clinicaltrials.gov/study/NCT05263388 (Accessed June 2025) 4 – Andersen, A. N., Nelson, S. M., Fauser, B. et al. (2017). Individualized versus conventional ovarian stimulation for in vitro fertilization: A multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertility and Sterility, 107(2), 387-396. 5 – Bosch E, Havelock J, Martin FS, Rasmussen BB, Klein BM, Mannaerts B, Arce JC; ESTHER-2 Study Group. Follitropin delta in repeated ovarian stimulation for IVF: a controlled, assessor-blind Phase 3 safety trial. Reprod Biomed Online. 2019 Feb;38(2):195-205. PMID: 30594482. 6 – Ishihara O, Arce JC, Japanese Follitropin Delta Phase 3 Trial G. Individualized follitropin delta dosing reduces OHSS risk in Japanese IVF/ICSI patients: a randomized controlled trial. Reprod Biomed Online. 2021 May;42(5):909-18. PubMed PMID: 33722477. Epub 2021/03/17. 7 – Qiao J, Zhang Y, Liang X, et al. A randomised controlled trial to clinically validate follitropin delta in its individualised dosing regimen for ovarian stimulation in Asian IVF/ICSI patients. Hum Reprod. 2021 Jun 28;36(9):2452-62. PubMed PMID: 34179971. Epub 2021/06/29. 8 – Blockeel C, Griesinger G, Rago R, et al. Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study). Frontiers in Endocrinology. 2022 Dec 22;13:992677. PMID: 36619578. SOURCE: Ferring Pharmaceuticals

Phase 3Clinical ResultDrug Approval

10 Jul 2024

·www.globenewswire.com

FSH-free versus FSH-primed infertility treatment of women with polycystic ovary syndrome using biphasic in vitro maturation: a randomized clinical trial

AMSTERDAM, July 10, 2024 (GLOBE NEWSWIRE) -- This randomized, controlled trial was conducted at a tertiary IVF center, Ho Chi Minh City, Vietnam. Between January 2023 and June 2023, 120 women were randomized. Eligible women were aged 18–37 years with polycystic ovarian syndrome (PCOS). After providing written informed consent, participants were randomized (1:1) to undergo CAPA-IVM with or without FSH-priming. Participants in the FSH-priming group received two days of recombinant FSH (rFSH) injections before oocyte pick-up; no rFSH was given in the non-FSH group. All retrieved cumulus oocyte complexes underwent biphasic in vitro maturation (CAPA-IVM). Matured oocytes underwent fertilization through ICSI procedure, and were cultured to blastocyst stage followed by vitrification. Participants underwent a single blastocyst transfer during a frozen replacement cycle. The primary endpoint was the number of matured oocytes. The number of matured oocytes after CAPA-IVM did not differ significantly between the non-FSH and FSH groups (13 [9; 18] vs. 14 [7; 18]; absolute difference –1 [95% confidence interval –5, 4]). There were also no significant between-group differences in other oocyte and embryology outcomes, including the number of cumulus-oocyte complexes, number of fertilized oocytes, total number of blastocysts and good blastocysts, and total number of frozen embryos. The live birth rate was 38.3% in the non-FSH group and 31.7% in the FSH group, with no statistically significant difference. The miscarriage rate at <12 weeks’ gestation was 5.0% in both groups. Maternal complications were infrequent and occurred at a similar rate in the non-FSH and FSH groups; there were no preterm deliveries before 32 weeks’ gestation. The study results were presented by Dr. Tuong M Ho at the 40th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) on July 9th, 2024 in Amsterdam (The Netherlands) and have been submitted for publication in a leading reproductive medicine journal. Prof Dr Lan Vuong from The University of Medicine and Pharmacy at Ho Chi Minh City and MyDuc hospital, HCMC, Vietnam, who led the study, said: “This randomized controlled trial with 120 patients proves that CAPA-IVM without rFSH priming is as effective as two days of rFSH priming. With a live birth rate of 38% for single blastocyst transfer CAPA-IVM achieved a similar live birth rate than standard IVF with 8-10 days of rFSH treatment. This is great news and a milestone achievement. The data supports our belief that women with PCOS are suitable for a complete gonadotrophin free, alternative fertility treatment.” About CAPA-IVM CAPA-IVM is a novel approach to in-vitro maturation of oocytes recovered after no or minimal ovarian stimulation, that incorporates a capacitation step in the maturation of oocytes in vitro which enhances oocyte developmental competence. CAPA-IVM is a patient-friendly assisted reproductive technology method that may become an alternative option to conventional ovarian stimulation and IVF, with reduced treatment burden in some selected groups of patients. The worldwide rights to the CAPA-IVM technology are owned by Lavima Fertility, Inc. Lavima Fertility is developing a medical device for future application of this technology. www.lavimafertility.com For more information:André Rosenthal andre.rosenthal@lavimafertility.comJohan Smitz johan.smitz@lavimafertility.com

Clinical ResultClinical Study

11 Apr 2023

·www.fiercebiotech.com

Ferring's research site closure signals shift from internal to external R&D, CSO says

Ferring Pharma's CSO says the company's commitment to reproductive and maternal health products is unchanged even as R&D priorities shift. After more than 25 years, Ferring Pharmaceuticals suddenly shuttered a San Diego research institute in March just months after finishing a major renovation. It's all part of the plan, says Chief Scientific Officer Armin Metzger, Ph.D. The research executive, now in his seventh year with Ferring, said that the company is making a concerted pivot toward external innovation to make the best use of capital following two FDA approvals at the end of 2022. It's a shift that Metzger describes as a "fundamental" change. "We will still have internal discovery, but [be] much, much more external focused, giving more flexibility of allocating funds," he said in an interview with Fierce Biotech. The clear-eyed assessment of the company’s priorities set the record straight as to why the Ferring Research Institute, one of the company’s three main R&D hubs, closed after 27 years. The move resulted in nearly 90 staffers being laid off and came after Ferring finished renovations on the institute just last year. “[T]he turning point was that we got two FDA approvals of two first-in-class assets in one year,” said Metzger. “And this leads to the adaptation, again of the strategy—how we deliver innovation to the patients—and it is not an easy decision-making process.” In November 2022, Ferring nabbed FDA approval for the first fecal microbiota product, Rebyota, for adults with C. difficile following antibiotic treatment or recurrent infection. Just a few weeks later, gene therapy Adstiladrin was approved for bladder cancer. The new strategy is not a complete departure from Ferring’s existing work, as those now-approved assets originated from deals. Ferring acquired Rebiotix in April 2018, tacking on the C. difficile treatments, and then a month later, the Swiss pharma signed a commercialization agreement with FKD Therapies for the bladder cancer treatment. “I think a company of our size, with the investment needed now on the later stage, we can't entertain technology platforms in-house,” said Metzger, who added that Ferring will instead rely on "partnerships across the globe.” Ferring’s main therapeutic areas are remaining unchanged, however, including maternal and reproductive health, which Metzger called “the core” of the company. One of the priorities is bringing the infertility treatment Rekovelle to the U.S. after it nabbed approval in Europe and Switzerland. He expects feedback from the FDA in the second half of the year. In addition to Rekovelle, infertility treatments LutrePulse and Menopur are under development, along with Pabal, a med for postpartum hemorrhage. But the clinical-stage work is in limbo. A phase 2 trial for a treatment to address inadequate milk production, merotocin, was shuttered earlier this year due to low enrollment and a phase 2 infertility treatment is now absent from the company’s pipeline. A spokesperson for Ferring did not immediately respond to a request for comment on the missing program. Regardless, Metzger says that in the next year, the company hopes to bolster its portfolio, including potentially boosting the indications for merotocin. This could also mean combination opportunities and female and male infertility assets from Ferring's reproductive medicine pipeline.

Drug ApprovalPhase 2AcquisitionGene TherapyLicense out/in

100 Deals associated with Follitropin delta

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	G03GA10	DB00066

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Infertility	Canada	Ferring, Inc.	22 Mar 2018
Infertility, Female	Australia	Ferring Pharmaceuticals Pty Ltd.	21 Sep 2017
Ovarian Stimulations	European Union	Ferring Pharmaceuticals A/S	12 Dec 2016
Ovarian Stimulations	Iceland	Ferring Pharmaceuticals A/S	12 Dec 2016
Ovarian Stimulations	Liechtenstein	Ferring Pharmaceuticals A/S	12 Dec 2016
Ovarian Stimulations	Norway	Ferring Pharmaceuticals A/S	12 Dec 2016

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Female infertility of tubal origin	Phase 3	Belgium	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	Brazil	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	Canada	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	Czechia	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	Denmark	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	France	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	Italy	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	Poland	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	Russia	Ferring Pharmaceuticals A/S	01 Oct 2013
Female infertility of tubal origin	Phase 3	Spain	Ferring Pharmaceuticals A/S	01 Oct 2013

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05263388 (ADAPT-1, CTgov)	Phase 3	Female infertility of tubal origin \| Infertility	302	Follitropin Delta (REKOVELLE (Follitropin Delta))	qfxkyeoisy(owhreeaexk) = sxtqoohyye wvaqcqfbsu (pwvviapnsc, ndeecjgpxe - gewiabypgu) View more	-	02 Apr 2025
				GONAL-F (Follitropin Alfa) (GONAL-F (Follitropin Alfa))	qfxkyeoisy(owhreeaexk) = jlbompubxx wvaqcqfbsu (pwvviapnsc, enjejrbsxn - drbjsrgfmn) View more
NCT05103228 (CTgov)	Not Applicable	Infertility \| Diminished ovarian reserve \| Ovarian Diseases	190	human menopausal gonadotropin+Follitropin delta+Follitropin Alfa (Lower Gonadotropin Dose Stimulation)	snujjsgpnw = pnznshujpv zexycektjg (bekivoistj, eilfjavtav - etccypeanh) View more	-	13 Dec 2024
				human menopausal gonadotropin+Follitropin delta+Follitropin Alfa (Higher Gonadotropin Dose Stimulation)	snujjsgpnw = wfdroyhvjg zexycektjg (bekivoistj, wgpjdawjli - ymnflrczru) View more
NCT03809429 (BEYOND, CTgov)	Phase 3	Infertility, Female	437	GONAPEPTYL+FE 999049+GnRH agonist (FE 999049 + GnRH Agonist (GONAPEPTYL))	yslotfkumk(npqbcdexlp) = xhzalqklxe xspbcgioyr (qqbqyafggu, 5.9) View more	-	13 May 2024
				CETROTIDE+FE 999049+GnRH antagonist (FE 999049 + GnRH Antagonist (CETROTIDE))	yslotfkumk(npqbcdexlp) = omsnlvkgzl xspbcgioyr (qqbqyafggu, 5.5) View more
NCT03809429 (BEYOND, Pubmed \| Hum Reprod) Manual	Phase 3	Infertility, Female AMH ≤35 pmol/l	437	follitropin deltaGONAPEPTYL (GnRH agonist protocol)	prkwadwlnj(zkrektvoar) = qeeufqcrxc ysslvtcqdf (ykvqzuinzd, 5.9) View more	Positive	09 May 2024
				FE 999049follitropin deltaCETROTIDE (GnRH antagonist protocol)	prkwadwlnj(zkrektvoar) = gsfbkrfrhj ysslvtcqdf (ykvqzuinzd, 5.5) View more
NCT03740737 (RITA-1, CTgov)	Phase 3	Female infertility of tubal origin \| Infertility \| Infertility, Male	579	Follitropin delta (FE 999049 (Follitropin Delta))	tkehnyqijg = fgijoysmnf ozibkxonuh (biwbbwxlwx, evfojemvkl - vesslwjzup) View more	-	18 Jan 2024
				Placebo (Placebo)	tkehnyqijg = lqxdvneloa ozibkxonuh (biwbbwxlwx, yfkqhsehmi - xhivgzaias) View more
NCT03738618 (RITA-2, CTgov)	Phase 3	Female infertility of tubal origin \| Infertility, Female	588	Follitropin delta (FE 999049 (Follitropin Delta))	rkxotyuvpf = gigwsxawbs kltvxxlmtj (loebeuhwkk, lqvrhpxjmd - tuqygvvixc) View more	-	18 Jan 2024
				Placebo (Placebo)	rkxotyuvpf = aklwudyzpn kltvxxlmtj (loebeuhwkk, agfcbbtauc - hmbgcjlscv) View more
NCT04150861 (Pubmed)	Phase 1	-	24	Follitropin delta 12 μg	syzlebndzn(hcmtzycvst) = bthwgeppbt ihqqjyaxvj (aizujywxej ) View more	-	07 Dec 2022
				Follitropin delta 18 μg	syzlebndzn(hcmtzycvst) = ziosdmbntk ihqqjyaxvj (aizujywxej ) View more
NCT03393780 (PROFILE, Pubmed \| Front Endocrinol (Lausanne))	Not Applicable	Ovarian Stimulations	944	Follitropin delta	tphkesadjy(feffimfxat) = most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]) okaszlgvyk (zogalqbhkj )	Positive	01 Jan 2022
NCT03228680 \| NCT01956110 (Pubmed \| Reprod Biomed Online)	Phase 3	-	800	follitropin delta (Japanese women)	sbrxqkxrkt(yssfpmxdwb) = svejvdvumw ddfokpjdmy (efdqrrghrp )	-	23 Sep 2021
				follitropin delta (White women)	sbrxqkxrkt(yssfpmxdwb) = pbwlknwrqn ddfokpjdmy (efdqrrghrp )
NCT03296527 (Pubmed \| Hum Reprod) Manual	Phase 3	-	1,009	follitropin delta	vkhqnyqzrc(oycrlfbrha) = nduiljhatv ljzuatqgnt (xblajrqvjx ) View more	Positive	18 Aug 2021
				follitropin alfa	vkhqnyqzrc(oycrlfbrha) = udhdtpuete ljzuatqgnt (xblajrqvjx ) View more

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