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Study Comparing Corifollitropin Alfa and Modified Natural Cycles for Women with Subfertility and Low Ovarian Response

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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 studying treatments for subfertility, a condition where individuals have difficulty conceiving. The study will compare two approaches to help women who are expected to have a low response to ovarian stimulation, which is a process used in assisted reproductive technology (ART) to encourage the ovaries to produce eggs. The first approach involves using a medication called corifollitropin alfa, known by the brand name Elonva, which is a solution for injection. The second approach involves up to three modified natural cycles, which are less intensive treatments that aim to support the natural menstrual cycle.

The purpose of the study is to compare the chances of achieving at least one good quality blastocyst, which is an early stage of embryo development, after using corifollitropin alfa versus the modified natural cycles. A blastocyst is considered good quality if it meets specific criteria known as the Gardner score. Participants in the study will receive either the medication or a placebo, and their progress will be monitored over a period of time to assess the outcomes.

Throughout the study, participants will receive injections of the medication under the skin, a method known as subcutaneous use. Other medications involved in the study include ganirelix (Orgalutran), choriogonadotropin alfa (Ovitrelle), and follitropin beta (Puregon), all of which are also solutions for injection. The study aims to provide valuable insights into the effectiveness of these treatments in improving the chances of conception for women with subfertility.

The research process

The trial runs in 6 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, body mass index, and ovarian reserve parameters.

    Informed consent is required, which involves understanding the study's purpose and procedures.

  2. Step 2

    Initial medication administration

    The first medication administered is Elonva (corifollitropin alfa), a solution for injection given subcutaneously. This is a single dose of 150 micrograms.

  3. Step 3

    Daily medication regimen

    Following the initial dose, Orgalutran (ganirelix) is administered daily. This involves a subcutaneous injection of 0.25 mg/0.5 mL solution.

    This medication is used to prevent premature ovulation during the stimulation phase.

  4. Step 4

    Ovulation trigger

    Once the follicles are adequately developed, Ovitrelle (choriogonadotropin alfa) is administered. This is a subcutaneous injection of 250 micrograms/0.5 mL solution in a pre-filled syringe.

    This medication triggers the final maturation of the eggs.

  5. Step 5

    Egg retrieval and embryo transfer

    Egg retrieval is scheduled approximately 36 hours after the Ovitrelle injection.

    Following fertilization, a single embryo transfer is performed, aiming for a good quality blastocyst.

  6. Step 6

    Monitoring and follow-up

    Regular monitoring is conducted to assess the development of the embryo and the success of the transfer.

    The probability of having an ongoing pregnancy is evaluated 6 to 8 weeks after the embryo transfer.

Who can join the trial?

11 criteria

  • Women who need **Assisted Reproductive Technology (ART)** and are expected to have a low response to **ovarian stimulation**. This means their ovaries might not respond well to the treatment.
  • Women who fit into specific groups based on the **POSEIDON classification**, which helps doctors understand how well a woman's ovaries might respond to treatment:
  • **Group 3**: Women under 35 years old with a low number of eggs in their ovaries before treatment. This is shown by an **AFC** (Antral Follicle Count) of less than 5 or an **AMH** (Anti-Müllerian Hormone) level of less than 1.2 ng/ml. The AMH test should be done within the last 12 months.
  • **Group 4**: Women 35 years or older with a low number of eggs in their ovaries before treatment, also shown by an AFC of less than 5 or an AMH level of less than 1.2 ng/ml.
  • Must have signed and dated an **Informed Consent Form (ICF)**, which means they agree to participate in the study after understanding what it involves.
  • Age between 18 and 44 years old.
  • **Body Mass Index (BMI)** between 18.5 and 34.9 kg/m². BMI is a measure of body fat based on height and weight.
  • Have regular menstrual cycles, which means periods occur every 21 to 35 days.
  • Must have two ovaries.
  • Currently wishing to become pregnant.
  • Agree to have a **Single Embryo Transfer (SET)**, which means only one embryo will be placed in the uterus during the treatment.

Who cannot join the trial?

3 criteria

  • Men cannot participate in the study. Only women are eligible.
  • Individuals who are not experiencing subfertility cannot participate. Subfertility means having difficulty getting pregnant.
  • Participants must not belong to a vulnerable population. This means they should not be in a group that needs special protection or care.
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Investigated drugs

  • Corifollitropin Alfa (CFA)

    is a medication used in this trial to stimulate the ovaries. It helps in the development of multiple eggs in women who are undergoing assisted reproductive technology (ART) treatments. The goal is to increase the chances of obtaining a good quality blastocyst, which is an early stage of embryo development. This medication is given as a single injection and is designed to work over a week, reducing the need for daily injections.

  • Modified Natural Cycle (MNC)

    is a type of fertility treatment that involves minimal stimulation of the ovaries. In this trial, it is used as a comparison to the controlled ovarian stimulation with Corifollitropin Alfa. The aim is to see if this approach can also lead to the development of a good quality blastocyst in women who are expected to have a low response to ovarian stimulation. This method relies more on the body's natural cycle, with some assistance to improve the chances of success.

What is already known about the treatment

Corifollitropin Alfa – This medication is administered via injection and is used in assisted reproductive technology (ART) to stimulate the ovaries in women with subfertility, particularly those expected to have a low response to ovarian stimulation. It is currently being studied in clinical trials to compare its effectiveness in producing good quality blastocysts against modified natural cycles. Corifollitropin Alfa works by stimulating the follicles in the ovaries to grow and mature, which is essential for successful fertilization. It belongs to the pharmacological class of gonadotropins, which are hormones that play a key role in reproductive processes.

Investigated diseases

Subfertility – Subfertility is a condition where a person has a reduced ability to conceive naturally. It is characterized by a prolonged time to achieve pregnancy compared to the average population. Unlike infertility, where conception is not possible without medical intervention, subfertility implies that conception can occur but may take longer. The condition can affect both men and women and may be due to various factors such as hormonal imbalances, structural issues, or lifestyle factors. In women, it may involve irregular ovulation or issues with the fallopian tubes or uterus. In men, it can be related to sperm quality or quantity.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509094-23-00Protocol codeMONACOEstimated enrolment300 patientsSponsorUniversitair Ziekenhuis Gent

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