Delving into the Latest Updates on Urofollitropin (Serono) with Synapse

Overview

Basic Info

Drug Type

Hormone

Synonyms

Fertinex, Fertinorm HP, Follitropin human

+ [6]

Target

FSHR

Action

agonists

Mechanism

FSHR agonists(Follicle-stimulating hormone receptor agonists)

Therapeutic Areas

Urogenital Diseases

Active Indication

Female infertility associated with anovulation

Inactive Indication-

Originator Organization

Merck Serono SA

Active Organization

Ferring GmbHFerring Arzneimittel GmbhFerring Holding SA

+ [1]

Inactive Organization

Ferring Pharmaceuticals SA

EMD Serono, Inc.

IBSA Institut Biochimique SA

License Organization-

Drug Highest PhasePhase 3

First Approval Date

United States (18 Sep 1986),

Infertility

RegulationOrphan Drug (United States)

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Structure/Sequence

Sequence Code 3246α

Sequence Code 3253α

The aim of this study will be to compare between 4 different induction protocols in women who:
Failed to achieve ovulation after clomiphene citrate treatment at a dose of 150mg daily (if the patient can tolerate this dose) for 5 days for 3 cycles or only 100 mg daily for the same duration (if she can't tolerate higher dose)
Failed to achieve pregnancy after 3 cycles of ultrasound indicated ovulation with clomiphene citrate treatment at a dose of 100mg or 150mg daily.
All induction protocols will be carried out in non-IVF cycles, and continued for 3 cycles or until pregnancy whichever will be earlier.

Start Date01 Jun 2022

Sponsor / Collaborator

Menoufia University

EUCTR2016-004034-14-IT

/ Unknown statusPhase 2/3IIT

Randomized controlled phase IIb-III clinical trial to assess the effectiveness of different regimens with u-FSH in the infertile male - UFO – UROFOLLITROPIN IN OLIGOZOOSPERMIA

Start Date11 Oct 2018

Sponsor / Collaborator-

NCT02544191

/ Unknown statusPhase 2IIT

GnRHa Combined With hCG and hMG for Treatment of Patients With Non-obstructive Azoospermia: A Single-center Prospective Study in China

Preliminary reports showed that hormonal treatment may improve the chance of retrieving viable testicular sperm from men with NOA. It was generally believed that gonadotrophin treatment would be ineffective in the presence of high plasma levels of endogenous gonadotrophin.The purpose of this study is to determine whether GnRHa(gonadotropin-releasing hormone agonist) combined with hCG(human chorionic gonadotropin) and hMG(human menopausal gonadotropin) are effective in the treatment of non-obstructive azoospermia.

Start Date01 Dec 2015

Sponsor / Collaborator

Affiliated Jinling Hospital, Medical School of Nanjing University

100 Clinical Results associated with Urofollitropin (Serono)

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100 Translational Medicine associated with Urofollitropin (Serono)

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100 Patents (Medical) associated with Urofollitropin (Serono)

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119

Literatures (Medical) associated with Urofollitropin (Serono)

01 Sep 2021·European Journal of Obstetrics & Gynecology and Reproductive BiologyQ4 · MEDICINE

YouTube as a source of information on gonadotropin self-injections

Q4 · MEDICINE

Article

Author: Seçilmiş, Özlem ; Çintesun, Ersin ; Çintesun, Feyza Nur İncesu

OBJECTIVETo investigate the comprehensiveness, quality, and reliability of YouTube videos that target teaching patients gonadotropin self-injections.STUDY DESIGNVideos demonstrating gonadotropin self-injections were searched using the keywords "Gonal-f injection," "Puregon injection," "Menapur injection," "Merional injection," "Fostimon injection," and "Menagon injection," on December 20th, 2020. The videos were divided into two categories as including "useful information" and "misleading information" by two physicians. A 5-point global quality scale (GQS) and 5-point modified DISCERN scale were used for the assessments of quality and reliability, respectively.RESULTSAmong 110 videos, 90 (81.8%) were found to include useful information and 20 (18.2%) were found to give misleading information. The kappa statistic for inter-observer agreement was 0.817 (p < 0.001). Useful videos were the most comprehensive and had the highest reliability and quality scores. We found that all videos uploaded by universities or professional organizations included useful information. However, there was no significant difference between useful and misleading videos regarding audience interaction analysis parameters (p > 0.05). On the other hand, mean reliability, GQS, and comprehensiveness scores were higher in the useful information group than in the other group. As the subgroup analysis was performed by source, patient opinion videos had lower reliability, comprehensiveness, and GQS scores than videos created by other sources (p < 0.001).CONCLUSIONOur analysis revealed that there were a significant number of English-language YouTube videos, with high quality, rich content, and reliability that could be sources of information on the accurate technique of gonadotropin self-injections. However, some misleading information videos may lead to negative outcomes. Therefore, physicians should ensure that online sources are comprehensive and reliable for the use of their patients with infertility. Also, YouTube health videos should be checked for both reliability and ethical standards.

01 Jan 2020·April-2020

Consequences of twinning induction to Noemi ewes by a recombinant human follicle-stimulating hormone compared with pituitary-derived porcine follicle-stimulating hormone on follicular dynamics, maternal biochemical attributes, and neonatal traits

Article

Author: Ateah, Mohamed A ; El-Deen, Mohamed Ahmed Shehab ; El-Dawas, Abdulrahman O ; Zeitoun, Moustafa Mohamed

Aim: The aim of this study was to investigate the effectiveness of using recombinant human follicle-stimulating hormone (FSH) compared with pituitary-derived porcine FSH given as one dose or multiple doses on the neonatal traits, follicular dynamics, and maternal blood biochemical constituents in Noemi ewes. Materials and Methods: A 3×2 factorial arrangement was designed utilizing 60 adults Noemi ewes to test the effects of using two sources of FSH (human vs. porcine) in addition to control, either given as a single total dose or six descending doses to provoke twinning. Six treatments (T) were tested (n=10 ewes/T). C1 and C6 served as control ewes given saline as one dose and six doses, respectively; H1 and H6 ewes were given human FSH as one and six doses; and P1 and P6 ewes were given porcine FSH similar to the above treatments. Saline and/or FSH administration were administered at days 8, 9, and 10 of the 10-day controlled internal drug release (CIDR) implant. At CIDR removal, fertile rams were used for natural mating. Blood samples for the assessment of serum metabolites were collected. Results: Twinning increased in FSH-treated ewes than control. However, giving FSH of either source as a single dose resulted in a higher incidence of stillbirths. Pregnancy rates were 30, 40, 50, 60, 70, and 80% in C1, C6, P1, P6, H1, and H6, respectively. Respective percent of ewes delivering twins/multiple birth was 0, 0, 80, 66.7, 71.4, and 87.5%. FSH of human source was more efficient for folliculogenesis than porcine FSH. Administration of FSH increased blood cholesterol, decreased high-density lipoprotein; however, low-density lipoprotein levels were not different than control. Moreover, an interaction (p<0.05) exists between source and type of FSH administration on blood glucose. Six doses of FSH elevated blood protein. Blood albumin decreased by porcine-FSH but not affected by human-FSH. Blood globulins were not different due to source of FSH, whereas giving FSH as six doses increased globulins than in single-dose protocol. Contrariwise, an interaction was found between source and type of FSH administration on elevating the activity of alanine aminotransferase and reducing the activity of aspartate aminotransferase. Conclusion: Administration of human FSH at 180 IU in six descending doses resulted in the best neonatal outcomes and maternal health in Noemi ewes.

01 Feb 2018·Urologia Journal

Effectiveness of highly purified urofollitropin treatment in patients with idiopathic azoospermia before testicular sperm extraction

Article

Author: Natali, Alessandro ; Carini, Marco ; Capece, Marco ; Morgia, Giuseppe ; Falcone, Marco ; Timpano, Massimiliano ; Della Camera, Pier Andrea ; Serni, Sergio ; Morselli, Simone ; Russo, Giorgio I. ; Gacci, Mauro ; Tasso, Giovanni ; Cito, Gianmartin ; Minervini, Andrea ; Cocci, Andrea ; Morelli, Girolamo

Introduction: Recent evidences demonstrated that male factor alone is responsible for about 30% cases of infertility. Human follicle-stimulating hormone (hFSH) has been introduced to increase sperm concentration, spermatogonial population, or both natural or assisted pregnancy rates (PRs) in oligozoospermic subjects with normal concentrations of gonadotropins. Methods: Fifty infertile men affected by idiopathic azoospermia were enrolled in this study, after undergoing medical history, physical and clinical examination, baseline semen parameters and hormonal plasma concentrations. Inclusion criteria were infertility for at least 2 years, idiopathic azoospermia, FSH <12 mIU/ml. Twenty-five patients were allocated to treatment with hFSH three times/week per 3 months (Fostimon), and 25 patients underwent just testicular sperm extraction (TESE) without medical treatment. All patients underwent, after 3 months, assisted reproduction techniques (ARTs) with TESE. The primary outcome was represented by the differences in the sperm retrieval rate (SRR) between groups, while the secondary outcomes were the differences in PR and fertilization rate (FR). Results: We observed a PR of 15% (3/25) and 28% (7/25) in control and treated group, respectively. SRR after medical treatment and ART was 24% (6/25), while in the control group was 12.5% (2/25). The sperm in the ejaculate of five patients (20%) after medical treatment exhibited a mean concentration of 0.9 million/ml and a mean motility of 12%. The FR was significantly greater in the treatment group with respect to the control group, 30% and 20%, respectively. Conclusions: FSH treatment showed greater efficacy rather than control by increasing the rate of PR and FR in azoospermic patients who underwent TESE.

100 Deals associated with Urofollitropin (Serono)

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External Link

KEGG	Wiki	ATC	Drug Bank
D06269	Urofollitropin (Serono)	G03GA04	DB00094

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Female infertility associated with anovulation	Phase 3	China	Ferring Arzneimittel Gmbh	17 Oct 2013
Female infertility associated with anovulation	Phase 3	China	Ferring Holding SA	17 Oct 2013
Female infertility associated with anovulation	Phase 3	China	Hong Kong Ferring Pharmaceutical Co., Ltd. Beijing Representative Office	17 Oct 2013
Female infertility associated with anovulation	Phase 3	China	Ferring GmbH	17 Oct 2013
Infertility, Female	Preclinical	China	Ferring Pharmaceuticals SA	20 Jun 2014
Infertility	Preclinical	United States	EMD Serono, Inc.	18 Sep 1986

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01969201 (FAST, CTgov)	Phase 4	Infertility	710	Urofollitrophin (Fostimon®)	qaseeiiyhr(osuiyclcza) = humsxxvarj dtkybwuiwz (tsdcjxnfdq, gfejcxfdtx - uduudsdmzu) View more	-	09 Oct 2019
				Follitrophin alpha (Gonal-F®)	qaseeiiyhr(osuiyclcza) = bslszlnwke dtkybwuiwz (tsdcjxnfdq, pdqoblxptl - eeofrygngv) View more
NCT01921166 (Diminished Ovarian Reserve, CTgov)	Phase 4	Infertility	23	Menopur+Clomid+Bravelle+Follistim+Gonal f (Clomiphene Plus Gonadotropins)	mxurdchzbf(jcswunzgnv) = ypecobgyje amkvzqeagf (mngutnwopb, hpilvvcump - pmlumtagep) View more	-	23 Feb 2018
				Leuprolide flare (Leuprolide Flare)	mxurdchzbf(jcswunzgnv) = lqshmlmdzv amkvzqeagf (mngutnwopb, btiimqnatr - zrxcfagbfe) View more
NCT01417195 (COMBINE, CTgov)	Phase 4	Infertility	122	Menopur+Bravelle (Menopur and Bravelle Combination)	(vncpzzpzvl) = kdrqtragrh yxticblrnx (vbaatzgciw, odynkhifyi - fgffbyzfln) View more	-	24 Apr 2014
				Menopur (Menopur Alone)	(vncpzzpzvl) = fytwxjusjh yxticblrnx (vbaatzgciw, ukgcoqfmpb - ectwwfkuiw) View more

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