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Study on the Effect of Lutropin Alfa to Improve Ovarian Reserve in Patients Undergoing IVF/ICSI Due to Tubal, Male Factor, or Unexplained Infertility

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on helping women who are undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) due to issues like blocked fallopian tubes, male infertility, or unexplained infertility. The study is testing a treatment called Luveris, which contains a substance known as lutropin alfa. This treatment is given as an injection under the skin and is designed to improve the number of eggs that can be developed in the ovaries.

The purpose of the study is to see if taking lutropin alfa at a dose of 187.5 international units (IU) each day for 60 days can increase the ovarian reserve, which is the number of eggs available in the ovaries. This is measured by checking the levels of a hormone called anti-Müllerian hormone (AMH) in the blood. The study will also look at other factors like the number of eggs that can be developed after 30 and 60 days, the response of the ovaries to the treatment, and the safety of using lutropin alfa.

Participants in the study will receive either the lutropin alfa treatment or a placebo. The study will monitor various outcomes, including the success of embryo transfers, pregnancy rates, and any potential side effects. The goal is to gather information that could help improve fertility treatments for women facing challenges in conceiving.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, hormone levels, and willingness to participate.

    Informed consent is required to proceed with the study.

  2. Step 2

    Pre-treatment phase

    The pre-treatment involves administering rhLH (recombinant human luteinizing hormone) at a dose of 187.5 IU per day.

    This medication is given as a subcutaneous injection for a duration of 60 days.

    The goal of this phase is to improve ovarian reserve, which is measured by an increase in basal AMH (anti-Müllerian hormone) levels.

  3. Step 3

    Monitoring and assessment

    Throughout the pre-treatment phase, regular monitoring is conducted to assess changes in AFC (antral follicle count) and AMH levels.

    Safety evaluations of the treatment are also performed during this period.

  4. Step 4

    Completion of pre-treatment

    After 60 days of pre-treatment, a final assessment of ovarian reserve is conducted.

    The primary endpoint is to confirm the improvement in ovarian reserve as indicated by increased basal AMH levels.

  5. Step 5

    Follow-up and outcomes

    Secondary outcomes such as ovarian response, pregnancy rates, and safety are evaluated.

    The study also tracks various pregnancy-related outcomes, including implantation rate, miscarriage rate, and birth outcomes.

Who can join the trial?

12 criteria

  • Patients must be admitted to an IVF/ICSI cycle. This means they are undergoing a process to help with fertility.
  • The reasons for being in the IVF cycle can be due to issues with the fallopian tubes, male fertility problems, or unexplained infertility.
  • Patients need to have an **AFC** (Antral Follicle Count) of at least 5. This is a count of small follicles in the ovaries, checked within 3 months before the study.
  • Patients should have **basal AMH** (Anti-Müllerian Hormone) levels of at least 1 ng/ml, measured within 3 months before the study. This hormone helps assess the ovarian reserve.
  • Patients must be between the ages of 25 and 38 at the time of the study.
  • **D3 Basal LH** (Luteinizing Hormone) levels should be between 1-6 IU/L, checked within 3 months before the study. This hormone is important for reproductive health.
  • **D3 Basal FSH** (Follicle-Stimulating Hormone) levels should be less than 8 IU/L, measured within 3 months before the study. This hormone helps control the menstrual cycle and egg production.
  • **D3 Estradiol** levels should be less than 70 pg/ml, checked within 3 months before the study. Estradiol is a form of estrogen, a female hormone.
  • Patients must be willing to participate in the study.
  • Patients should be able to understand and follow the study procedures.
  • Patients should be **eumenorrheic**, meaning they have regular menstrual cycles, and have low LH levels. They should be candidates for IVF/ICSI due to tubal issues, male factors, or unexplained infertility.
  • Patients must accept and sign the informed consent, which is a document explaining the study and confirming their agreement to participate.

Who cannot join the trial?

4 criteria

  • Patients who are not admitted to an IVF/ICSI cycle cannot participate. IVF/ICSI are medical procedures to help with pregnancy.
  • Patients who are not female cannot participate.
  • Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection or care.
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Investigated drugs

rhLH is a medication used in this trial to improve ovarian reserve. It is a form of luteinizing hormone that is administered to help increase the number of recruitable antral follicles in the ovaries. This treatment aims to enhance fertility by boosting the levels of a hormone that plays a crucial role in the reproductive process.

What is already known about the treatment

Recombinant Human Luteinizing Hormone (rhLH) – This medication is administered through injection and is currently being studied in clinical trials for its potential benefits in fertility treatments. It is primarily used to enhance ovarian reserve in women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycles, particularly for those with tubal or male factor infertility, or unexplained infertility. The mechanism of action involves stimulating the ovaries to increase the number of recruitable antral follicles, which may improve the chances of successful conception. It is classified as a gonadotropin, a type of hormone that plays a crucial role in reproductive health.

Investigated diseases

Infertility – Infertility is a condition where a person is unable to conceive after a year of regular, unprotected intercourse. It can be due to various factors, including issues with the reproductive system of either partner. In women, it may be caused by problems such as blocked fallopian tubes or hormonal imbalances. In men, it can result from low sperm count or poor sperm motility. Sometimes, the cause of infertility is unknown, which is referred to as idiopathic infertility. The condition can lead to emotional stress and requires medical evaluation to determine the underlying cause.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517407-36-00Estimated enrolment84 patientsSponsorAzienda Ospedaliero Universitaria Di Modena

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).