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CLINICAL TRIALS PROFILE FOR LUTROPIN ALFA

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All Clinical Trials for Lutropin Alfa

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00328926 ↗	Luveris® (Lutropin Alfa for Injection) in Women With Hypogonadotropic Hypogonadism (Luteinizing Hormone [LH] Less Than [<] 1.2 International Unit Per Liter [IU/L])	Terminated	EMD Serono	Phase 4	2006-03-01	Sponsor has decided to discontinue Luveris® in the United States (US) due to level of customer demand for this product, and not due to any efficacy or safety concerns.
NCT00749853 ↗	Efficacy of Ovarian Stimulation Based on FSHR Genotype Status	Suspended	Medical University of Vienna	Phase 3	2015-05-01	Available data from in vitro studies and clinical trials indicate that genetic factors play a significant role in the success of controlled ovarian stimulation (COS) prior to in vitro fertilization - embryo trandfer (IVF-ET). Women with the FSHR Ser680Asn Ser/Ser genotype make up between 13% and 26% of women undergoing IVF-ET and are characterised by higher basal FSH serum concentrations, the need for a higher amount of FSH for COS, and a higher risk of poor response to COS and cycle cancellation. The investigators therefore intend to perform a study to investigate whether a dose-intensified COS protocol based on FSHR genotype status in women with the FSHR Ser680Asn Ser/Ser genotype is more effective than routine management in terms of - the mean number of follicles - the mean number of embryos - the rate of poor responders - the rate of women with cycle cancellations, and v) the clinical pregnancy rates. Eligible women will be randomized to a stimulation protocol characterised by a longer duration and increased dosage of FSH stimulation (group A) or a standard stimulation protocol (group B).
NCT01075815 ↗	A Clinical Trial to Determine the Effect of Lutropin Alfa on Embryo Quality and Implantation Rate in Advanced Reproductive Age	Terminated	Merck, S.L., Spain	Phase 2	2008-11-01	This is a multicentric, open, randomized, comparative trial aimed to assess the influence of recombinant luteinizing hormone (r-LH) supplementation during controlled ovarian stimulation (COS) in advanced reproductive age in terms of improved embryo competence which allows to transfer less embryos to avoid high grade multiple pregnancy without reducing the pregnancy rate.

Clinical Trial Conditions for Lutropin Alfa

Condition Name

Condition Name for Lutropin Alfa
Intervention	Trials
Infertility	4
Ovulation Induction	3
Infertility, Female	3

Condition MeSH

Condition MeSH for Lutropin Alfa
Intervention	Trials
Infertility	8
Infertility, Female	3
Hyperandrogenism	1

Clinical Trial Locations for Lutropin Alfa

Trials by Country

Trials by Country for Lutropin Alfa
Location	Trials
Spain	4
Russian Federation	2
Austria	1
United States	1
Germany	1

Trials by US State

Trials by US State for Lutropin Alfa
Location	Trials
Massachusetts	1

Clinical Trial Progress for Lutropin Alfa

Clinical Trial Phase

Clinical Trial Phase for Lutropin Alfa
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	2
Phase 2	5

Clinical Trial Status

Clinical Trial Status for Lutropin Alfa
Clinical Trial Phase	Trials
Recruiting	3
Completed	3
Terminated	3

Clinical Trial Sponsors for Lutropin Alfa

Sponsor Name

Sponsor Name for Lutropin Alfa
Sponsor	Trials
Merck KGaA	5
Merck, S.L., Spain	2
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany	1

Sponsor Type

Sponsor Type for Lutropin Alfa
Sponsor	Trials
Industry	9
Other	5