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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR LUTROPIN ALFA

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Clinical Trials for Lutropin Alfa

Trial ID Title Status Sponsor Phase 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 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 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 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.
NCT01075815 A Clinical Trial to Determine the Effect of Lutropin Alfa on Embryo Quality and Implantation Rate in Advanced Reproductive Age Terminated Merck KGaA Phase 2 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.
NCT01079949 A Phase II Study to Assess the Efficacy and Safety of Luveris® (Lutropin Alfa) in Mid Follicular Phase for Controlled Ovarian Stimulation (COS) in Advanced Reproductive Age Terminated Merck, S.L., Spain Phase 2 Ovarian reserve is related to chronological age; 35 years of age is the accepted threshold for significant decline in assisted reproductive technologies (ART) success with scarce follicular recruitment and poor oocyte retrieval. New therapeutic schemes are sought to improve follicular response in ovarian ageing because of the increasing number of infertile women aged older than 35 years who are trying to get pregnant. The advent of gonadotropin releasing hormone analogue antagonist (GnRHant) offers new perspectives to address the issues related to advanced reproductive age since it prevents premature luteinizing hormone (LH) surges while not causing suppression in the early follicular phase. Gonadotropin releasing hormone analogue antagonists are administered in the latter stage of the ovarian stimulation to prevent LH surge by competitive blockade of gonadotropin releasing hormone (GnRH) receptors, thus producing a marked decrease in LH levels just when the interplay between follicle stimulating hormone (FSH) and LH becomes important to complete follicular development and oocyte competence. Some studies in the past have shown the potential of recombinant human LH (r-hLH) supplementation in women of advanced reproductive age to improve oocyte quality, but these studies are of small size and did not provide data on the physiological mechanism behind the benefit obtained. This randomized, comparative, parallel controlled Phase II study will be conducted in infertile female subjects aged 35-42 years undergoing in-vitro fertilization (IVF)/intra cytoplasmic sperm injection (ICSI), to investigate whether the addition of r-hLH (when the lead follicle is greater than [>] 14 millimeter [mm] in size), to the standard protocol with recombinant human FSH (r-hFSH) under GnRHant, improves the number and quality of oocytes retrieved, implantation rate, and pregnancy rate, while assessing the hormonal milieu in the ovarian follicular fluid. Comparison will be performed against ovarian stimulation without addition of r-hLH, that is (i.e.) with r-hFSH under GnRHant alone.
NCT01079949 A Phase II Study to Assess the Efficacy and Safety of Luveris® (Lutropin Alfa) in Mid Follicular Phase for Controlled Ovarian Stimulation (COS) in Advanced Reproductive Age Terminated Merck KGaA Phase 2 Ovarian reserve is related to chronological age; 35 years of age is the accepted threshold for significant decline in assisted reproductive technologies (ART) success with scarce follicular recruitment and poor oocyte retrieval. New therapeutic schemes are sought to improve follicular response in ovarian ageing because of the increasing number of infertile women aged older than 35 years who are trying to get pregnant. The advent of gonadotropin releasing hormone analogue antagonist (GnRHant) offers new perspectives to address the issues related to advanced reproductive age since it prevents premature luteinizing hormone (LH) surges while not causing suppression in the early follicular phase. Gonadotropin releasing hormone analogue antagonists are administered in the latter stage of the ovarian stimulation to prevent LH surge by competitive blockade of gonadotropin releasing hormone (GnRH) receptors, thus producing a marked decrease in LH levels just when the interplay between follicle stimulating hormone (FSH) and LH becomes important to complete follicular development and oocyte competence. Some studies in the past have shown the potential of recombinant human LH (r-hLH) supplementation in women of advanced reproductive age to improve oocyte quality, but these studies are of small size and did not provide data on the physiological mechanism behind the benefit obtained. This randomized, comparative, parallel controlled Phase II study will be conducted in infertile female subjects aged 35-42 years undergoing in-vitro fertilization (IVF)/intra cytoplasmic sperm injection (ICSI), to investigate whether the addition of r-hLH (when the lead follicle is greater than [>] 14 millimeter [mm] in size), to the standard protocol with recombinant human FSH (r-hFSH) under GnRHant, improves the number and quality of oocytes retrieved, implantation rate, and pregnancy rate, while assessing the hormonal milieu in the ovarian follicular fluid. Comparison will be performed against ovarian stimulation without addition of r-hLH, that is (i.e.) with r-hFSH under GnRHant alone.
NCT01110707 A Randomised, Phase II, Comparative Study With a Parallel Control for Evaluating the Efficacy and Safety of Combined Treatment of Lutropin Alpha and Recombinant Human Luteinizing Hormone in the Middle of the Controlled Ovarian Stimulation Follicular Completed Merck KGaA Phase 2 This was a prospective, randomised, Phase II, comparative study with a parallel control for evaluating the efficacy and safety of combined treatment of recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH). The combined treatment was administered at the middle of the follicular phase in subjects undergoing in-vitro fertilisation (IVF) through intracytoplasmic sperm injection (ICSI) and transfer of embryos (ET). Few evidences suggest that aged subjects have more possibilities of obtaining a benefit from the combined use of FSH and LH. This study was designed to find out whether the addition of r-hLH on the sixth day of stimulation with r-hFSH in conventional protocol improves the assisted reproduction in terms of quality of recovered oocytes, implantation rates and pregnancy rates in subjects.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Lutropin Alfa

Condition Name

Condition Name for Lutropin Alfa
Intervention Trials
Infertility 4
Ovulation Induction 3
Infertility, Female 3
In Vitro Fertilisation 1
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Condition MeSH

Condition MeSH for Lutropin Alfa
Intervention Trials
Infertility 8
Infertility, Female 3
Hypogonadism 1
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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
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Trials by US State

Trials by US State for Lutropin Alfa
Location Trials
Massachusetts 1
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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 4
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Clinical Trial Status

Clinical Trial Status for Lutropin Alfa
Clinical Trial Phase Trials
Completed 3
Terminated 3
Recruiting 2
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Clinical Trial Sponsors for Lutropin Alfa

Sponsor Name

Sponsor Name for Lutropin Alfa
Sponsor Trials
Merck KGaA 5
Merck, S.L., Spain 2
Sheba Medical Center 1
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Sponsor Type

Sponsor Type for Lutropin Alfa
Sponsor Trials
Industry 8
Other 4
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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Fuji
Argus Health
US Army
Express Scripts
Citi
Medtronic
UBS
Daiichi Sankyo

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