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.
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).
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.
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