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Study on Infertility: Comparing Corifollitropin Alfa and Follitropin Beta for Women Undergoing Elective Fertility Preservation

Registered drugNo placebo
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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 infertility and involves a treatment approach for women who are preserving their fertility. The study is comparing two different methods of stimulating the ovaries to produce mature eggs. The first method involves two doses of a medication called Corifollitropin Alfa (CFA), while the second method uses one dose of CFA followed by daily doses of another medication called recombinant Follicle Stimulating Hormone (rFSH). These medications are used to help the ovaries produce more eggs, which can then be collected and preserved for future use.

The purpose of the study is to compare the number of mature eggs retrieved using these two different methods. Participants will receive either the two doses of CFA or the combination of CFA and rFSH. The study will also look at other factors, such as the total number of eggs collected, hormone levels on the day of egg collection, and any side effects like Ovarian Hyperstimulation Syndrome (OHSS), which is a condition where the ovaries become swollen and painful. Additionally, participants will complete a quality of life questionnaire to assess their experience during the study.

The study will take place over a period of time, with participants undergoing the treatment and monitoring process. This includes receiving the medications, attending appointments for blood tests, and having the eggs collected. The goal is to determine which method is more effective in helping women preserve their fertility by producing a higher number of mature eggs.

The research process

The trial runs in 7 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 hormone levels.

    Participants must be between 18 and 40 years old, with a body mass index greater than 18 and less than 30 kg/m².

  2. Step 2

    Initial medication administration

    The first step involves the administration of corifollitropin alfa (CFA) through a subcutaneous injection.

    This medication is provided as either Elonva 100 micrograms or Elonva 150 micrograms solution for injection.

  3. Step 3

    Daily medication regimen

    Following the initial CFA injection, participants may receive daily doses of recombinant follicle-stimulating hormone (rFSH) for ovarian stimulation.

    The rFSH is administered as Puregon 900 IU/1.08 ml solution for injection.

  4. Step 4

    Ovarian stimulation monitoring

    Participants undergo regular monitoring to assess the response to ovarian stimulation.

    This includes blood tests and ultrasound examinations to evaluate hormone levels and follicle development.

  5. Step 5

    Final oocyte maturation

    The final stage involves triggering oocyte maturation using a GnRH-agonist (GnRH-a) such as Decapeptyl diario 0.1 mg solution for injection.

    This step is crucial for preparing the oocytes for retrieval.

  6. Step 6

    Oocyte retrieval

    Oocytes are retrieved following the final maturation trigger.

    The primary goal is to compare the number of mature oocytes retrieved between different medication protocols.

  7. Step 7

    Post-retrieval assessment

    Participants complete a quality of life questionnaire called FertiQoL to assess the impact of the trial on their well-being.

    The incidence of ovarian hyperstimulation syndrome (OHSS) is also monitored.

Who can join the trial?

6 criteria

  • The study is for women only.
  • Participants must be between 18 and 40 years old.
  • Participants should have a Body Mass Index (BMI) greater than 18 and less than 30. BMI is a measure of body fat based on height and weight.
  • Participants must have an Antral Follicle Count (AFC) of 20 or less. AFC is a test that counts the number of small follicles in the ovaries.
  • Participants should have an Anti-Mullerian Hormone (AMH) level of 3 ng/ml or less. AMH is a hormone that helps to estimate the number of eggs left in the ovaries.
  • Participants must be able to visit the study center for necessary procedures like blood tests, appointments, and receiving medication.

Who cannot join the trial?

3 criteria

  • Patients who are not experiencing infertility cannot participate.
  • Only female patients are eligible; male patients cannot participate.
  • Patients who are part of a vulnerable population, such as those who may not be able to give informed consent, cannot participate.
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Investigated drugs

  • Corifollitropin alpha (CFA)

    is a medication used to stimulate the ovaries to produce multiple eggs in women undergoing fertility treatments. It is given as an injection and works by mimicking the natural hormones in the body that control the growth and release of eggs from the ovaries.

  • Recombinant Follicle Stimulating Hormone (rFSH)

    is another medication used in fertility treatments to stimulate the ovaries. It is also given as an injection and helps in the development of multiple eggs. In this trial, rFSH is used after the initial administration of Corifollitropin alpha to enhance the ovarian stimulation process.

What is already known about the treatment

  • Corifollitropin Alpha

    This medication is administered via injection and is used in fertility treatments. It is currently being studied in clinical trials for its effectiveness in stimulating the ovaries to produce mature eggs in women undergoing fertility preservation. The main therapeutic indication is infertility, specifically to aid in the retrieval of mature oocytes. At the molecular level, Corifollitropin Alpha works by stimulating the follicles in the ovaries to grow and mature, similar to the natural hormone FSH (follicle-stimulating hormone). It is classified as a gonadotropin, which is a type of hormone that plays a key role in reproductive processes.

  • Recombinant Follicle Stimulating Hormone (rFSH)

    This medication is also administered via injection and is used in fertility treatments. It is being evaluated in clinical trials for its role in enhancing ovarian stimulation when used after Corifollitropin Alpha. The primary therapeutic indication is infertility, helping to increase the number of mature eggs available for retrieval. rFSH works by directly stimulating the ovarian follicles to grow and mature, mimicking the action of natural FSH. It is classified as a gonadotropin, essential for reproductive health and fertility treatments.

Investigated diseases

Infertility – Infertility is a condition where an individual or couple is unable to conceive a child after a year of regular, unprotected sexual intercourse. It can affect both men and women and may result from various factors, including hormonal imbalances, structural problems, or issues with sperm or egg production. In women, infertility can be related to ovulation disorders, blocked fallopian tubes, or uterine abnormalities. In men, it often involves low sperm count, poor sperm motility, or blockages that prevent sperm delivery. The condition can be temporary or permanent, depending on the underlying cause. Infertility can lead to emotional stress and may require medical intervention to achieve pregnancy.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506162-31-00Protocol codeFSD-SEQ-2023-09Estimated enrolment194 patientsSponsorSantiago Dexeus Font Fundacio Privada

sourced from the EU Clinical Trials Register and site verification

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