Corifollitropin alfa

Generic Name
Corifollitropin alfa
Brand Names
Elonva
Drug Type
Biotech
Chemical Formula
-
CAS Number
195962-23-3
Unique Ingredient Identifier
T7K20Y2GWY
Background

Corifollitropin alfa, also known as Elonva is used in women undergoing fertility treatment to stimulate the development of more than one mature egg (oocyte) at a time in the ovaries. This drug used together with a gonadotropin-releasing hormone (GnRH) antagonist, a type of medicine also used in fertility treatments. Elonva is available only by prescription .

In July 2014, Merck announced the receipt of a Complete Response Letter (CRL) from the U.S. FDA for its New Drug Application for this drug. Corifollitropin alfa is marketed as Elonva in more than 75 countries .

Corifollitropin alfa is produced by a method known as ‘recombinant DNA technology’. This means that it is made by cells into which a DNA has been introduced that makes them able to produce corifollitropin alfa .

Multiple studies and a meta-analysis suggest that corifollitropin alfa is as efficacious as recombinant FSH in terms of live birth rate, ongoing pregnancy rate, as well as clinical pregnancy rate. The increased in the number of eggs retrieved under corifollitropin alfa regimen represents the elevated effectiveness of this drug, however, warns at the same time against the possibility of an increased risk of ovarian hyperstimulation in the high responder study group of women , .

Indication

Controlled ovarian stimulation in cases of women who are undergoing fertility treatment to stimulate the development of more than one mature egg simultaneously in the ovaries in combination with a gonadotrophin-releasing hormone (GnRH) antagonist (a type of medicine also used in fertility treatments).

Associated Conditions
-
Associated Therapies
-

Type of Gonadotropin and Embryo Kinetics of Development

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2015-03-30
Last Posted Date
2022-08-11
Lead Sponsor
IVI Madrid
Target Recruit Count
201
Registration Number
NCT02402192

Corifollitropin Alfa Versus Daily rFSH in the Controlled Ovarian Stimulation of Poor Responders

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2014-10-02
Last Posted Date
2016-01-18
Lead Sponsor
IVI Sevilla
Target Recruit Count
26
Registration Number
NCT02254928
Locations
🇪🇸

IVI Barcelona, Barcelona, Spain

🇪🇸

IVI Madrid, Madrid, Spain

🇪🇸

IVI Sevilla, Seville, Spain

and more 1 locations

Corifollitropin Alfa Application in PCOS Patients

First Posted Date
2014-08-13
Last Posted Date
2014-08-13
Lead Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Target Recruit Count
30
Registration Number
NCT02215135
Locations
🇨🇳

Department of Obstetrics and Gynecology, Shin-Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan

Use of Corifolitropin Alfa in Oocyte Donors

First Posted Date
2014-08-11
Last Posted Date
2015-07-17
Lead Sponsor
IVI Madrid
Target Recruit Count
300
Registration Number
NCT02213627
Locations
🇪🇸

IVI Madrid, Madrid, Spain

Corifollitropin Alfa Compared to Daily rFSH in Poor Responders Undergoing ICSI

Phase 4
Completed
Conditions
Interventions
First Posted Date
2014-01-28
Last Posted Date
2014-05-14
Lead Sponsor
Aristotle University Of Thessaloniki
Target Recruit Count
80
Registration Number
NCT02046655
Locations
🇬🇷

Unit for Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki, Thessaloniki, Greece

Corifollitropin Alfa Followed by Menotropin for Poor Ovarian Responders Trial

First Posted Date
2013-03-22
Last Posted Date
2016-06-23
Lead Sponsor
Universitair Ziekenhuis Brussel
Target Recruit Count
150
Registration Number
NCT01816321
Locations
🇧🇪

Universitair Ziekenhuis Brussel, Brussels, Belgium

🇻🇳

University of Medicine and Pharmacy of Ho Chi Minh City, Ho Chi Minh City, Vietnam

Treatment of Poor Ovarian Responders With Corifollitropin Alfa Followed by hpHMG in a Short GnRH Agonist Protocol

First Posted Date
2012-11-22
Last Posted Date
2013-05-09
Lead Sponsor
Universitair Ziekenhuis Brussel
Target Recruit Count
51
Registration Number
NCT01732068
Locations
🇧🇪

Centre for Reproductive Medicine UZ Brussel, Brussels, Belgium

D2 Versus D4 Corifollitropin Alfa in GnRH Antagonists

Phase 4
Completed
Conditions
Interventions
First Posted Date
2012-07-04
Last Posted Date
2014-12-03
Lead Sponsor
Universitair Ziekenhuis Brussel
Target Recruit Count
67
Registration Number
NCT01633580
Locations
🇧🇪

UZ Brussel, Jette, Belgium

A Post Marketing Observational Study of the Safety and Efficacy of Elonva (Corifollitropin Alfa) in General Practice (P08165)

Completed
Conditions
Interventions
First Posted Date
2011-08-03
Last Posted Date
2022-02-03
Lead Sponsor
Organon and Co
Target Recruit Count
472
Registration Number
NCT01408615
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