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Last Updated: June 17, 2025

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 ↗ LuverisĀ® (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 LuverisĀ® 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.
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 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lutropin Alfa

Condition Name

Condition Name for Lutropin Alfa
Intervention Trials
Infertility 4
Ovulation Induction 3
Infertility, Female 3
Ovarian Stimulation 2
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Condition MeSH

Condition MeSH for Lutropin Alfa
Intervention Trials
Infertility 8
Infertility, Female 3
Inflammation 1
Hyperandrogenism 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
Poland 1
Austria 1
United States 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 5
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Clinical Trial Status

Clinical Trial Status for Lutropin Alfa
Clinical Trial Phase Trials
Completed 4
Terminated 3
Unknown status 2
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Clinical Trial Sponsors for Lutropin Alfa

Sponsor Name

Sponsor Name for Lutropin Alfa
Sponsor Trials
Merck KGaA 5
Merck KGaA, Darmstadt, Germany 5
Merck, S.L., Spain 2
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Sponsor Type

Sponsor Type for Lutropin Alfa
Sponsor Trials
Industry 14
Other 5
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Lutropin Alfa: Clinical Trials, Market Analysis, and Projections

Introduction to Lutropin Alfa

Lutropin alfa, a recombinant human luteinizing hormone (LH), is a crucial component in the treatment of infertility, particularly in assisted reproductive technologies (ART). It is often used in combination with follicle-stimulating hormone (FSH) analogues to stimulate ovulation and improve fertility outcomes.

Clinical Trials Update

Current and Ongoing Trials

Several clinical trials are currently underway to evaluate the efficacy and safety of lutropin alfa in various settings:

  • Effect on Embryo Quality and Implantation: An exploratory study by Merck is investigating the impact of lutropin alfa on embryo quality and implantation rates in women of advanced reproductive age. This trial aims to provide insights into how lutropin alfa can improve ART outcomes in older women[4].

  • Combination Therapy: Another significant area of research involves the combination of lutropin alfa with follitropin alfa. Clinical trials are assessing the efficacy of this fixed combination in improving fertility treatment outcomes. This combination is expected to simplify the treatment regimen and enhance patient compliance[3].

  • Clinical Trial Design and Outcomes: There is a focus on improving clinical trial design to ensure more complete reporting of outcomes. This includes better standardized protocols and more comprehensive data collection to provide clearer insights into the drug's effectiveness[3].

Market Analysis

Global Market Overview

The market for human chorionic gonadotropin (hCG) and other gonadotropins, including lutropin alfa, is growing steadily. Here are some key market trends and projections:

  • Market Size and Growth: The global human chorionic gonadotropin market, which includes lutropin alfa, was estimated to be around $1.98 billion in 2022 and is projected to grow further by 2032. This growth is driven by increasing demand for infertility treatments and advancements in ART[2].

  • Segmentation: The market is segmented by application (infertility treatment, ovulation induction, pregnancy testing), source (urine, serum), form (injectable, oral, nasal spray), manufacturing process (extraction from urine, recombinant DNA technology), and end users (hospitals, clinics, diagnostic laboratories, individuals)[2].

  • Regional Analysis: The market is dominated by regions such as North America, Europe, and the Asia Pacific. China, in particular, has seen significant growth, with the recombinant human lutropin alfa market being monopolized by Merck Serono as of 2018[5].

Competitive Landscape

The female infertility drug market, which includes lutropin alfa, is characterized by a limited number of established companies. Key players such as EMD Serono, Merck & Co, and Ferring Pharmaceuticals dominate the market with blockbuster drugs like Gonal-F (follitropin alfa), Follistim (follitropin beta), and Menopur (menotropins). These drugs collectively held over 50% of the total female infertility market in 2018[3].

Projections and Future Outlook

Market Growth Projections

The female infertility drug market, including lutropin alfa, is expected to grow from $1.8 billion in 2018 to $2.5 billion by 2028 across the seven major markets (US, France, Germany, Italy, Spain, UK, and Japan) at a compound annual growth rate (CAGR) of 3.4%. This growth is partly driven by the increasing rates of ART treatments[3].

Pipeline and Emerging Trends

  • Late-Stage Pipeline Agents: Drugs like nolasiban, which is expected to improve embryo implantation rates during ART cycles, are gaining attention. Nolasiban is projected to be worth $320 million in the US and 5EU by 2028[3].

  • Fixed Combination Therapies: The fixed combination of follitropin alfa and lutropin alfa is a promising area of development. This combination is expected to simplify treatment regimens and enhance patient compliance[3].

  • Long-Acting FSH Analogues: Research into long-acting FSH analogues and pre-filled pen injection devices is also underway, aiming to make treatment more convenient and effective[3].

Unmet Needs and Opportunities

Improved IVF Success Rates

One of the significant unmet needs in the field of infertility treatment is improving IVF success rates per cycle. Lutropin alfa, especially when used in combination with other gonadotropins, is being studied to address this need[3].

Patient-Friendly Treatments

There is a growing demand for oral and longer-acting drugs that simplify the IVF process. Lutropin alfa, in its current form and in combination therapies, is being evaluated for its potential to meet these demands[3].

Novel Treatments for Poor Responders

Novel treatments for poor responders to conventional fertility treatments are another area of focus. Lutropin alfa, as part of combination therapies, may offer better outcomes for these patients[3].

Key Takeaways

  • Clinical Trials: Ongoing trials are evaluating the efficacy of lutropin alfa in improving embryo quality and implantation rates, especially in women of advanced reproductive age.
  • Market Growth: The global market for gonadotropins, including lutropin alfa, is projected to grow due to increasing demand for infertility treatments and advancements in ART.
  • Competitive Landscape: The market is dominated by a few key players, with a focus on combination therapies and long-acting analogues.
  • Future Outlook: Emerging trends include the development of fixed combination therapies and long-acting FSH analogues to improve treatment outcomes and patient compliance.

FAQs

What is lutropin alfa used for?

Lutropin alfa is used in the treatment of infertility, particularly in assisted reproductive technologies (ART), to stimulate ovulation and improve fertility outcomes.

Which companies dominate the market for lutropin alfa?

Key players such as EMD Serono, Merck & Co, and Ferring Pharmaceuticals dominate the market for lutropin alfa and other gonadotropins.

What are the current clinical trials focusing on for lutropin alfa?

Current clinical trials are focusing on the effect of lutropin alfa on embryo quality and implantation rates, especially in women of advanced reproductive age, and the efficacy of fixed combination therapies with follitropin alfa.

What is the projected market growth for lutropin alfa?

The market for lutropin alfa is expected to grow from $1.8 billion in 2018 to $2.5 billion by 2028 at a CAGR of 3.4%.

What are some of the unmet needs in infertility treatment that lutropin alfa aims to address?

Lutropin alfa aims to address unmet needs such as improving IVF success rates per cycle, developing patient-friendly treatments, and providing novel treatments for poor responders.

Sources

  1. ClinicalTrials.gov - Search Results for Follitropin AND Lutropin alfa.
  2. Market Research Future - Human Chorionic Gonadotropin Market Research Report.
  3. Business Wire - Female Infertility: Global Opportunity Analysis & Forecast, 2019-2028.
  4. Merck Group - Clinical Trial Details: Effect of Lutropin Alfa on Embryo Quality.
  5. GlobeNewswire - China Recombinant Human Lutropin alfa (Luveris) Market Report 2018-2022.
Last updated: 2024-12-31

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