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Follitropin Delta

Follitropin Delta, also known as REKOVELLE, is a recombinant human follicle-stimulating hormone (FSH) used in controlled ovarian stimulation for assisted reproductive technologies like in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). This article explores the use of Follitropin Delta in clinical trials, highlighting its effectiveness, safety, and unique individualized dosing approach based on a woman’s anti-Müllerian hormone (AMH) levels and body weight.

Table of Contents

What is Follitropin Delta?

Follitropin Delta is a medication used in fertility treatments. It is a type of hormone called recombinant human follicle-stimulating hormone (rFSH). This means it is a laboratory-made version of the natural hormone FSH that stimulates egg production in women. Follitropin Delta is also known by the brand names REKOVELLE and FE 999049[1][2].

How Does Follitropin Delta Work?

Follitropin Delta works by stimulating the ovaries to produce eggs. It is used as part of controlled ovarian stimulation in women undergoing fertility treatments such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). These are procedures where eggs are collected from a woman’s ovaries and fertilized with sperm in a laboratory to create embryos, which are then transferred back into the woman’s uterus[1][3].

What Conditions Does Follitropin Delta Treat?

Follitropin Delta is used to treat infertility in women. Specifically, it is prescribed for:

  • Controlled ovarian stimulation: This is a process used in fertility treatments to stimulate the ovaries to produce multiple eggs[1].
  • Preparation for IVF or ICSI: These are assisted reproductive technologies used to help couples with fertility issues conceive[3].
  • Intrauterine insemination: This is a fertility treatment where sperm is placed directly into the uterus during ovulation[4].

How is Follitropin Delta Administered?

Follitropin Delta is administered as a subcutaneous injection, which means it is injected just under the skin. It typically comes in a pre-filled injection pen for ease of use. The medication is usually injected once daily during the stimulation phase of the fertility treatment cycle[1][2].

Dosing of Follitropin Delta

One of the unique features of Follitropin Delta is its individualized dosing regimen. The dose is determined based on two main factors:

  1. Body weight: This helps estimate how the medication will be distributed in the body.
  2. Anti-Müllerian hormone (AMH) level: This is a hormone that helps predict how a woman’s ovaries will respond to stimulation[1].

This personalized approach aims to reduce the risk of under- or over-response to the treatment. The daily dose is usually fixed throughout the stimulation period, which can last up to 20 days[2][5].

Effectiveness of Follitropin Delta

Clinical trials have shown that Follitropin Delta is effective in stimulating egg production for fertility treatments. Some key findings include:

  • It is as effective as other FSH medications in terms of pregnancy rates and live birth rates[1].
  • The individualized dosing approach helps more women achieve the optimal number of eggs (typically considered to be 8-14 eggs)[1].
  • It may reduce the need for dose adjustments during treatment compared to conventional FSH medications[2].

Potential Side Effects and Risks

Like all medications, Follitropin Delta can cause side effects. Some potential side effects include:

  • Injection site reactions: Such as redness, pain, itching, swelling, or bruising at the injection site[2].
  • Ovarian Hyperstimulation Syndrome (OHSS): This is a condition where the ovaries become swollen and painful. Symptoms can include abdominal pain, bloating, nausea, and in severe cases, shortness of breath. The individualized dosing of Follitropin Delta aims to reduce the risk of OHSS[1][2].
  • Multiple pregnancies: As with all fertility treatments, there is a risk of multiple pregnancies (twins, triplets, etc.)[3].

It’s important to discuss all potential risks and side effects with your healthcare provider before starting treatment.

Ongoing Research on Follitropin Delta

Several clinical trials are ongoing or have been recently completed to further study Follitropin Delta. These studies are looking at various aspects of the medication, including:

  • Its use in different populations, such as women in different age groups or with different AMH levels[6].
  • Its effectiveness when used in combination with other fertility medications[7].
  • Its use in specific fertility treatment protocols, such as freeze-all cycles where all embryos are frozen for later use[8].
  • Its effectiveness and safety in real-world clinical practice settings[9].

These ongoing studies will help to further refine the use of Follitropin Delta and potentially expand its applications in fertility treatment.

Aspect Details
Drug Name Follitropin Delta (REKOVELLE)
Type Recombinant human follicle-stimulating hormone (FSH)
Primary Use Controlled ovarian stimulation for IVF/ICSI
Unique Feature Individualized dosing based on AMH and body weight
Efficacy Non-inferior to conventional FSH treatments for pregnancy rates
Safety Reduced risk of OHSS and extreme ovarian responses
Administration Subcutaneous injection using a pre-filled pen
Dosing Duration Up to 20 days of stimulation
Monitoring Follicle development, hormone levels (e.g., estradiol, progesterone)
Common Side Effects Injection site reactions, potential for OHSS

FAQ

  • What is Follitropin Delta? Follitropin Delta, also known as REKOVELLE, is a recombinant human follicle-stimulating hormone (FSH) used for controlled ovarian stimulation in assisted reproductive technologies like IVF and ICSI. It is uniquely designed to provide individualized dosing based on a woman's AMH levels and body weight.
  • How does Follitropin Delta differ from other FSH medications? Follitropin Delta is the first rFSH treatment to use an individualized dosing regimen based on a woman's serum AMH level and body weight. This approach aims to optimize ovarian response and reduce the risk of complications like ovarian hyperstimulation syndrome (OHSS).
  • What are the main benefits of using Follitropin Delta? Clinical trials have shown that Follitropin Delta is non-inferior to conventional FSH treatments in terms of ongoing pregnancy rates and live births. It also demonstrates a reduced need for OHSS preventive measures and fewer cases of extreme ovarian responses.
  • How is the dose of Follitropin Delta determined? The dose of Follitropin Delta is determined using an algorithm that takes into account the woman's serum AMH level and body weight. This individualized approach aims to provide an optimal ovarian response for each patient.
  • What are the common side effects of Follitropin Delta? Common side effects of Follitropin Delta may include injection site reactions such as redness, pain, itching, swelling, and bruising. As with other FSH medications, there is also a risk of ovarian hyperstimulation syndrome (OHSS), though studies suggest a reduced incidence with Follitropin Delta's individualized dosing approach.

Ongoing Clinical Trials on Follitropin Delta

  • Study of fixed-dose follitropin delta for ovarian stimulation in women undergoing intrauterine insemination treatment for infertility

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Ovarian Stimulation Using Follitropin Delta and Dydrogesterone for Women Donating Eggs

    Recruiting

    1 1 1 1
    Investigated drugs:
    Belgium

  • Study on the Effect of Ovarian Stimulation with Follitropin Delta, Triptorelin, and Progesterone in Women with Infertility of Advanced Age

    Recruiting

    1 1 1 1
    Investigated drugs:
    Spain

  • Study on the Effectiveness and Safety of Follitropin Delta for Men with Unexplained Infertility

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Denmark Germany Italy Spain Sweden

  • Study on Ovarian Response in Women with Infertility Using Follitropin Delta and Menotrophin During Assisted Reproductive Technology

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy Spain

Glossary

  • Follitropin Delta: A recombinant human follicle-stimulating hormone (FSH) used for controlled ovarian stimulation in assisted reproductive technologies, with an individualized dosing regimen based on AMH levels and body weight.
  • Anti-Müllerian Hormone (AMH): A hormone produced by the ovaries that is used as a biomarker to predict ovarian response to stimulation and determine the appropriate dose of Follitropin Delta.
  • Controlled Ovarian Stimulation (COS): A process used in assisted reproductive technologies to stimulate the development of multiple follicles in the ovaries using gonadotropins like FSH.
  • In Vitro Fertilization (IVF): A type of assisted reproductive technology where an egg is fertilized by sperm outside the body and then implanted in the uterus.
  • Intracytoplasmic Sperm Injection (ICSI): A specialized form of IVF where a single sperm is injected directly into an egg to facilitate fertilization.
  • Ovarian Hyperstimulation Syndrome (OHSS): A potential complication of ovarian stimulation where the ovaries become swollen and painful, potentially leading to serious health issues.
  • Gonadotropin-Releasing Hormone (GnRH): A hormone used in fertility treatments to control the timing of ovulation and prevent premature LH surges.
  • Blastocyst: An embryo that has developed for 5-6 days after fertilization and has a fluid-filled cavity and two distinct cell types.
  • Oocyte: An immature egg cell in the ovary that can develop into a mature egg (ovum) ready for fertilization.
  • Luteal Phase Support: Hormonal supplementation given after ovulation or embryo transfer to support early pregnancy in assisted reproductive treatments.

References

  1. https://clinicaltrials.gov/study/NCT05173597
  2. https://clinicaltrials.gov/study/NCT04150861
  3. https://clinicaltrials.gov/study/NCT03296527
  4. https://clinicaltrials.gov/study/NCT03830723
  5. https://clinicaltrials.gov/study/NCT03228680
  6. https://clinicaltrials.gov/study/NCT05873725
  7. https://clinicaltrials.gov/study/NCT04503707
  8. https://clinicaltrials.gov/study/NCT03697031
  9. https://clinicaltrials.gov/study/NCT03393780