Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauterine Successful Experience (RISE)

The aim of this study is to evaluate the use of a fixed dose of 3.66 mcg of follitropin delta (Rekovelle) on ovarian response during ovarian stimulation for intrauterine insemination (IUI). The assumption is that this fixed dose will be effective while minimizing the risk of multiple pregnancies. A recent study demonstrated the efficacy of follitropin delta for ovarian stimulation in IUI, and it has been approved in France for controlled ovarian stimulation in assisted reproductive techniques such as in vitro fertilization (IVF) and IVF with intracytoplasmic sperm injection (ICSI). With an adapted dose of Rekovelle for patients with regular menstrual cycles, ovarian stimulation is optimized from the first attempt, promoting the development of two follicles to improve pregnancy chances while reducing the risk of multiple pregnancies. This approach aims to achieve pregnancy faster and provide a more comfortable treatment experience.

Start Date17 Dec 2025

Sponsor / Collaborator

Centre Hospitalier Intercommunal Créteil

[+1]

NCT06997900

/ RecruitingPhase 2

Menopur And Rekovelle Combination Study Version 2.0

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

/ Active, not 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

100 Clinical Results associated with Follitropin delta

100 Translational Medicine associated with Follitropin delta

100 Patents (Medical) associated with Follitropin delta

1,130

Literatures (Medical) associated with Follitropin delta

01 Jan 2026·BJU INTERNATIONAL

Post‐cycle therapy after short‐term anabolic‐androgenic steroid use: comparative outcomes in recreational bodybuilders

Article

Objectives:

To evaluate the clinical necessity and optimal pharmacological strategy for post‐cycle therapy (PCT) in recreational anabolic‐androgenic steroid (AAS) users with normal pre‐cycle reproductive profiles.

Subjects and Methods:

This retrospective, dual‐centre cohort study included 79 males who had completed ≤6 months of AAS use and had documented normal pre‐cycle reproductive hormone levels and semen parameters. Participants were managed with no treatment (NT; expectant monitoring), clomiphene citrate (CC) monotherapy (25 mg/day; selective oestrogen receptor modulation to stimulate gonadotrophin release), or CC + human chorionic gonadotrophin (hCG) (25 mg/day CC + hCG 1500 IU subcutaneously three times weekly; rapid androgen repletion and testicular stimulation). In patients with follicle‐stimulating hormone (FSH) <1.5 IU/L, recombinant FSH (rFSH; 75 IU subcutaneously three times weekly) was suggested to promote spermatogenesis. Linear mixed models and logistic regression analyses were used to evaluate group differences and predictors of recovery.

Results:

At baseline (T0), 89.9% of patients had erectile dysfunction and 69.7% exhibited azoospermia or severe oligozoospermia. Both pharmacological regimens accelerated hormonal recovery vs NT, with normalisation across groups by Month 6. Seminal recovery was significantly earlier in treated groups: at 12 months (T12), normozoospermia rates were 87.5% in CC + hCG, 69.2% in CC, and 58.6% in NT. Testicular volume increased ≥20% in 70.8% of CC + hCG vs 6.9% of NT. Combined therapy independently predicted normozoospermia (odds ratio [OR] 6.23, 95% confidence interval [CI] 1.32–29.4) and motility recovery (OR 4.85, 95% CI 1.27–18.4). All five men receiving rFSH achieved normozoospermia by T12. Sexual function improved across groups, with faster recovery in treated patients.

Conclusion:

Spontaneous hormonal recovery occurs within 6–12 months after AAS cessation, yet PCT facilitates earlier hormonal normalisation. The addition of hCG to CC was associated with superior recovery of semen parameters and testicular volume. These findings underscore the potential short‐term benefits of PCT and highlight the need for prospective randomised trials to establish evidence‐based treatment protocols.

01 Jan 2026·FERTILITY AND STERILITY

Ovarian stimulation with follitropin delta is safe and effective: results from the RITA randomized, double-blind, placebo-controlled trials

Article

Author: Doody, Kevin J ; Scheiber, Michael D ; Foster, Eric D ; Grover, Sarah A ; Heiser, Patrick W

OBJECTIVE:

To demonstrate the efficacy and safety of follitropin delta (recombinant follicle-stimulating hormone produced from the human cell line PER.C6) for ovarian stimulation in patients aged 18-34 and 35-42 years undergoing in vitro fertilization or intracytoplasmic sperm injection treatment in the United States.

DESIGN:

Two randomized, double-blind, placebo-controlled, parallel-group, multicenter trials (RITA-1 and RITA-2).

SUBJECTS:

A total of 1,165 patients (578 women aged 18-34 years in RITA-1 and 587 women aged 35-42 years in RITA-2), randomized 10:1 to follitropin delta or placebo.

INTERVENTION:

Ovarian stimulation with follitropin delta at a fixed starting dose (12 μg/d for patients aged <35 years and 15 μg/d for patients aged ≥35 years) for the first 4 stimulation days and subsequent dose adjustments as needed, or placebo as a reference group, in a gonadotropin-releasing hormone antagonist cycle.

MAIN OUTCOME MEASURES:

Cumulative ongoing pregnancy rate after fresh and cryopreserved cycles initiated within 12 months from start of ovarian stimulation.

RESULTS:

The cumulative ongoing pregnancy rates with follitropin delta were 64.0% in patients aged <35 years (RITA-1) and 43.9% in patients aged ≥35 years (RITA-2) vs. 0 with placebo, thus establishing superiority of follitropin delta to placebo (RITA-1, difference, 64.0% [95% confidence interval, 56.9%-68.1%]; RITA-2, difference, 43.9% [95% confidence interval, 37.0%-48.2%]). The cumulative live birth rates with follitropin delta were 62.5% in patients aged <35 years and 42.4% in patients aged ≥35 years. In the fresh transfer cycle, the ongoing pregnancy rates with follitropin delta were 49.5% in patients aged <35 years and 34.8% in patients aged ≥35 years, and the live birth rates were 48.2% and 33.9%, respectively. In cryopreserved transfer cycles, the ongoing pregnancy rates with follitropin delta were 44.2% in patients aged <35 years and 31.2% in patients aged ≥35 years, and the live birth rates were 42.8% and 29.9%, respectively. The incidence rates of ovarian hyperstimulation syndrome in the fresh cycle were 3.8% in patients aged <35 years and 2.4% in patients aged ≥35 years after treatment with follitropin delta.

CONCLUSION:

Follitropin delta, dosed on the basis of maternal age, is an effective and safe therapeutic for ovarian stimulation in in vitro fertilization/intracytoplasmic sperm injection patients.

TRIAL REGISTRATION:

For RITA-1, NCT03740737 (ClinicalTrials.gov), registered on October 24, 2018, first subject enrolled on October 26, 2018. For RITA-2, NCT03738618 (ClinicalTrials.gov), registered on October 24, 2018, first subject enrolled on October 29, 2018.

07 Dec 2025·Cureus Journal of Medical Science

Efficacy and Safety of Folisurge, a Biosimilar Recombinant Follicle-Stimulating Hormone, Versus Gonal-F in Assisted Reproductive Technology Practice in India: A Real-World Study

Article

Author: Gupta, Nitasha ; Zaidi, Sara ; Chandra, Vipin ; Nigam, Shipra ; Sanagoudar, Shashank ; Suwalka, Isha ; Punhani, Ritu ; Panday, Jyoti ; Mistari, Walmik ; Gahalan, Anjali ; Pandey, Nihita ; Bhoi, Nihar Ranjan

OBJECTIVE:

This study was conducted to compare the efficacy and safety of Folisurge, a biosimilar recombinant follicle-stimulating hormone (r-FSH), with Gonal-f, an innovator r-FSH, in patients undergoing assisted reproductive technology (ART).

METHODS:

In this non-interventional, investigator-initiated, real-world, retrospective study, females aged 21-40 years with a body mass index (BMI) ranging between 17 and 34.9 kg/m², with serum anti-Müllerian hormone (AMH) more than 1.2 ng/mL, undergoing controlled ovarian stimulation (COS), and those having received Folisurge or Gonal-f were included. The primary outcome was the mean number of metaphase II (MII) oocytes retrieved in each group. Secondary outcomes included the mean number of embryos formed and serum β-human chorionic gonadotropin (β-hCG) positive rate in each group.

RESULTS:

A total of 3090 women were included, out of which 1210 and 1880 received Folisurge and Gonal-f, respectively. The baseline demographics were comparable in the two groups. The mean antral follicle count (AFC) was significantly higher in the Folisurge vs. the Gonal-f group (23.8 vs. 20.6, p < 0.001). Also, the mean (SD) number of oocytes retrieved was significantly higher in the Folisurge vs. the Gonal-f group (18.1 (9.4) vs. 15.5 (8.3), p < 0.001). The mean (SD) number of MII oocytes retrieved with Folisurge was significantly higher than Gonal-f (13 (7.5) vs. 10.9 (6.6), p < 0.001). Also, the mean (SD) number of embryos formed was also higher in the Folisurge vs. the Gonal-f group (4.9 (4.1) vs. 4.7 (4.1), p = 0.022). The serum β-hCG positive rate was similar between the two groups (75.5% vs. 76.2%, p = 0.667). No major safety concerns were observed in the study.

CONCLUSION:

Folisurge was comparable to Gonal-f in terms of serum β-hCG positive rate. The higher yield of oocytes and embryos in the Folisurge group should be interpreted in the context of its higher baseline AFC, which may have influenced these results. No major safety concerns were observed.

News (Medical) associated with Follitropin delta

03 Dec 2025

·www.fiercepharma.com

Workplaces labor to keep staff as fertility support falls short, Ferring survey finds

More than 20% of employees said they feel unsupported in the workplace regarding fertility treatment. A Ferring Pharmaceuticals survey has found 39% of people undergoing fertility treatment are at least considering leaving their jobs, leading the drugmaker to question whether companies are doing enough to support employees. Ferring funded the survey and worked with Fertility Matters at Work and This Can Happen, groups that offer workplace support, on the project. Having initially targeted the U.K., the survey expanded to include Australia, France, Japan and Poland and to cover more than 3,600 employees and employers. The goal was to explore how fertility challenges affect people at work and what employers can offer.Two-thirds of respondents who have faced fertility challenges said their workplaces don’t offer support for employees undergoing fertility treatment. Support is rarest in France, where 88% of respondents said their employers lacked initiatives to help workers receiving fertility treatment.The survey found 60% of respondents lacked clear entitlement to time off for fertility appointments. The situation led people undergoing fertility treatment to record time off for appointments as paid, unpaid or annual leave. Almost 20% of respondents said the lack of flexibility led them to take sick leave. The presence or absence of support is informing decisions about where to work. Beyond finding that 39% of people undergoing fertility treatment are leaving or considering quitting their jobs, the survey revealed widespread interest in roles that provide fertility support. Almost three-quarters of people who are experiencing fertility challenges would be attracted to roles that provide support.While 75% of employers said they recognize fertility treatment as a significant life event, only 27% of employees who have experienced fertility challenges agree. More than 20% of employees said they feel unsupported, and 36% have felt pressure from their employer to work while undergoing treatment or investigations. Mental well-being is a particular concern for people undergoing fertility treatment.Signs suggest uptake of fertility treatment could increase. Babies conceived using assisted reproductive technology accounted for 2.6% of births in the U.S. in 2022. The figure rises to around 10% in Denmark and 12% in Spain. President Donald Trump acted to increase access to fertility care in the U.S. in October, including by inking a drug pricing deal with Merck KGaA's EMD Serono.Like EMD Serono, Ferring sells fertility drugs. Ferring’s portfolio includes the recombinant human follicle-stimulating hormone Rekovelle, which competes with drugs including the Gonal-f product covered by Trump’s deal with EMD Serono.

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

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.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenomyosis	Phase 3	Italy	Ferring Pharmaceuticals A/S	21 Feb 2019
Ovarian Diseases	Phase 3	Italy	Ferring Pharmaceuticals A/S	21 Feb 2019
Ovarian Hyperstimulation Syndrome	Phase 3	China	Ferring Pharmaceuticals A/S	01 Dec 2017
Ovarian Hyperstimulation Syndrome	Phase 3	South Korea	Ferring Pharmaceuticals A/S	01 Dec 2017
Ovarian Hyperstimulation Syndrome	Phase 3	Taiwan Province	Ferring Pharmaceuticals A/S	01 Dec 2017
Ovarian Hyperstimulation Syndrome	Phase 3	Vietnam	Ferring Pharmaceuticals A/S	01 Dec 2017
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

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06173869 (COCO, CTgov)	Phase 3	Female infertility of tubal origin \| Infertility, Female	301	FE 999049 (FE 999049)	chtzodcscj(ksogqvtbhl) = qvqhemuisb alddjmvdau (ppetsfyhtw, 5.2) View more	-	12 Feb 2026
				GONAL-F (GONAL-F)	chtzodcscj(ksogqvtbhl) = xcmrnmcpvu alddjmvdau (ppetsfyhtw, 5.3) View more
NCT05263388 (ADAPT-1, CTgov)	Phase 3	Female infertility of tubal origin \| Infertility	302	Follitropin Delta (REKOVELLE (Follitropin Delta))	rukujdrpch(igflatijtd) = eudypxynre llmvpncaad (oivuethuau, hzjktybeiw - zhrkrbvqod) View more	-	02 Apr 2025
				GONAL-F (Follitropin Alfa) (GONAL-F (Follitropin Alfa))	rukujdrpch(igflatijtd) = kfllcrweqq llmvpncaad (oivuethuau, hxsmofnnxu - mwbhwdmszi) View more
NCT05103228 (CTgov)	Not Applicable	Infertility \| Diminished ovarian reserve \| Ovarian Diseases	190	human menopausal gonadotropin+Follitropin delta+Follitropin Alfa (Lower Gonadotropin Dose Stimulation)	xdddjowmsg = zzayekyzce wxtfiuihst (zxrynbmnnq, yguyxhohaz - dymhgwvqvb) View more	-	13 Dec 2024
				human menopausal gonadotropin+Follitropin delta+Follitropin Alfa (Higher Gonadotropin Dose Stimulation)	xdddjowmsg = xxcxtxybza wxtfiuihst (zxrynbmnnq, uanqepavxl - iflrcilcwk) View more
NCT03809429 (BEYOND, CTgov)	Phase 3	Infertility, Female	437	GONAPEPTYL+FE 999049+GnRH agonist (FE 999049 + GnRH Agonist (GONAPEPTYL))	jeviayopam(dxngkhlzbx) = ewbwiiecvh rvdbzqdbvz (atfkuiicsl, 5.9) View more	-	13 May 2024
				GnRH antagonist+CETROTIDE+FE 999049 (FE 999049 + GnRH Antagonist (CETROTIDE))	jeviayopam(dxngkhlzbx) = erihttkiyu rvdbzqdbvz (atfkuiicsl, 5.5) View more
NCT03809429 (BEYOND, Pubmed \| Hum Reprod) Manual	Phase 3	Infertility, Female AMH ≤35 pmol/l	437	follitropin deltaGONAPEPTYL (GnRH agonist protocol)	kwbtkzdtpo(diilduikxj) = xtpchuzpkp vzbgzoqrfb (tikbaxkwzv, 5.9) View more	Positive	09 May 2024
				FE 999049follitropin deltaCETROTIDE (GnRH antagonist protocol)	kwbtkzdtpo(diilduikxj) = cjpyxctspg vzbgzoqrfb (tikbaxkwzv, 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))	niktoawamq = nvxhdicojf vwymndsfij (olmchqyijb, fptkbvxlgi - ccpocvpupu) View more	-	18 Jan 2024
				Placebo (Placebo)	niktoawamq = hihpcytxyn vwymndsfij (olmchqyijb, burekxmehj - ezaddkedia) View more
NCT03738618 (RITA-2, CTgov)	Phase 3	Female infertility of tubal origin \| Infertility, Female	588	Follitropin delta (FE 999049 (Follitropin Delta))	mcmtzjtwvr = jxxpwkpwiw wzdikozcdd (sukjwkmyfs, dkxxysmqwo - nvojtxvbdg) View more	-	18 Jan 2024
				Placebo (Placebo)	mcmtzjtwvr = ntjfsionlk wzdikozcdd (sukjwkmyfs, hfvohytjct - uhyqqivlmm) View more
NCT04150861 (Pubmed)	Phase 1	-	24	Follitropin delta 12 μg	rmaxvceawn(lwflbflmni) = fvhwynqyud fxdxvzqouy (spxwtvcorm ) View more	-	07 Dec 2022
				Follitropin delta 18 μg	rmaxvceawn(lwflbflmni) = pfjwgstoor fxdxvzqouy (spxwtvcorm ) View more
NCT03393780 (PROFILE, Pubmed \| Front Endocrinol (Lausanne))	Not Applicable	Ovarian Stimulations	944	Follitropin delta	knkthzaeql(tmcxyyzxuv) = most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]) wpxqgywsfa (ictjxpmair )	Positive	01 Jan 2022
NCT01956110 (NCT03228680, NCT01956110, Pubmed \| Reprod Biomed Online)	Phase 3	-	800	follitropin delta (Japanese women)	viofkjvbgl(tpommxhllh) = zggxvjogrl nlqldivkhm (opphvpgwxf )	-	23 Sep 2021
				follitropin delta (White women)	viofkjvbgl(tpommxhllh) = zczojdkzpg nlqldivkhm (opphvpgwxf )

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis