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Study Comparing Corifollitropin Alfa and Progestin Primed Ovarian Stimulation for Women with Subfertility Undergoing Elective Fertility Preservation or Genetic Testing

Verified siteRegistered 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 treatments for subfertility, a condition where individuals have difficulty conceiving. The study involves comparing two different methods of ovarian stimulation, which is a process used to encourage the ovaries to produce multiple eggs. The treatments being studied include Corifollitropin alfa (Elonva®) and a method called Progestin primed ovarian stimulation (PPOS). Additionally, the study will look at the use of Follitropin Beta (Puregon®) and Ganirelix (Orgalutran®) in conventional ovarian stimulation cycles.

The purpose of the study is to compare these treatments in terms of how they affect the quality of life and satisfaction of patients undergoing fertility preservation or preimplantation genetic testing (PGT). Participants will receive the treatments through subcutaneous injections, which means the medication is injected under the skin. The study will involve two cycles of treatment, and participants will be asked to complete questionnaires about their experiences and satisfaction after each cycle.

Throughout the study, participants will be monitored to assess their response to the treatments. The study aims to provide insights into which method may offer better outcomes for individuals seeking fertility treatments. The information gathered will help improve understanding of how these treatments impact patients' lives and may guide future approaches to managing 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 criteria such as age, body mass index, and the need for oocyte cryopreservation or IVF/ICSI with PGT-A.

  2. Step 2

    Medication administration

    The study involves two types of ovarian stimulation cycles: CFA/PPOS and conventional rFSH/GnRH antagonist cycles.

    Medications used include triptorelin acetate, follitropin beta, corifollitropin alfa, ganirelix, and desogestrel.

    Most medications are administered via subcutaneous injection, except for desogestrel, which is taken orally as a film-coated tablet.

  3. Step 3

    First stimulation cycle

    The first ovarian stimulation cycle begins with the administration of the prescribed medications.

    The goal is to stimulate the ovaries to produce multiple eggs for retrieval.

  4. Step 4

    Questionnaire completion

    At the end of each stimulation cycle, a questionnaire is completed to assess treatment-related quality of life and patient satisfaction.

    This occurs after the agonist trigger and before the oocyte retrieval.

  5. Step 5

    Second stimulation cycle

    A second ovarian stimulation cycle is conducted, following the same procedures as the first cycle.

    The aim is to compare the two types of stimulation cycles in terms of patient experience and outcomes.

  6. Step 6

    Final questionnaire

    Within three weeks after completing the second stimulation cycle, a final questionnaire is completed.

    This questionnaire gathers patient feedback on the overall experience and satisfaction with the treatment.

Who can join the trial?

4 criteria

  • Must have a reason for oocyte cryopreservation (freezing eggs for future use) or need IVF/ICSI (in vitro fertilization/intracytoplasmic sperm injection) and PGT-A (preimplantation genetic testing for aneuploidies, which checks embryos for genetic issues).
  • This should be your first ovarian stimulation cycle (a process to stimulate the ovaries to produce multiple eggs).
  • Must be a woman aged 18 years or older but younger than 41 years at the time of the first OPU (ovum pick-up, which is the procedure to collect eggs).
  • Your Body Mass Index (BMI) should be 18 kg/m² or more but less than 32 kg/m². BMI is a measure that uses your height and weight to work out if your weight is healthy.

Who cannot join the trial?

10 criteria

  • Participants must not have any other medical conditions that could interfere with the study.
  • Participants should not be taking medications that might affect the study results.
  • Participants must not have a history of severe allergic reactions.
  • Participants should not be pregnant or breastfeeding.
  • Participants must not have participated in another clinical trial recently.
  • Participants should not have any mental health conditions that could affect their ability to follow study instructions.
  • Participants must not have any substance abuse issues.
  • Participants should not have any serious heart, liver, or kidney problems.
  • Participants must not have any active infections.
  • Participants should not have any known genetic disorders that could affect the study.
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Investigated drugs

  • CFA

    is a medication used in ovarian stimulation cycles. It is part of a treatment plan to help stimulate the ovaries to produce multiple eggs, which can be used in fertility treatments such as in vitro fertilization (IVF).

  • PPOS

    is another medication used in ovarian stimulation. It is designed to help control the timing of ovulation and improve the chances of retrieving multiple eggs during a fertility treatment cycle.

  • rFSH

    is a medication that contains follicle-stimulating hormone. It is used to stimulate the ovaries to produce more eggs than usual, which is helpful in fertility treatments.

  • GnRH antagonist

    is a medication that helps prevent premature ovulation during fertility treatments. It works by blocking the natural hormone signals that trigger ovulation, allowing for better control over the timing of egg retrieval.

What is already known about the treatment

  • Recombinant Follicle Stimulating Hormone (rFSH)

    This medication is administered via injection and is used in fertility treatments to stimulate the ovaries to produce multiple eggs. It is well-established in medical literature and is commonly used in assisted reproductive technologies. The main therapeutic indication is for subfertility, particularly in women undergoing fertility preservation or preimplantation genetic testing. At the molecular level, rFSH works by binding to receptors on the surface of ovarian cells, promoting the growth and maturation of ovarian follicles. It is classified as a gonadotropin, which is a type of hormone that stimulates the activity of the gonads.

  • Gonadotropin-Releasing Hormone (GnRH) Antagonist

    This medication is also administered via injection and is used in fertility treatments to prevent premature ovulation during ovarian stimulation. It is widely recognized in medical literature and is used in conjunction with other fertility medications. The primary therapeutic indication is for subfertility, especially in women undergoing fertility preservation or preimplantation genetic testing. The mechanism of action involves blocking the GnRH receptors in the pituitary gland, which reduces the release of luteinizing hormone and follicle-stimulating hormone, thereby controlling the timing of ovulation. It is classified as a GnRH antagonist, which is a type of medication that inhibits the action of natural GnRH.

Investigated diseases

Subfertility – Subfertility is a condition where an individual or couple experiences difficulty in achieving pregnancy despite having regular unprotected intercourse. It is not the same as infertility, as subfertility implies a reduced level of fertility rather than a complete inability to conceive. The condition can be due to various factors affecting either partner, such as hormonal imbalances, ovulation disorders, or issues with sperm quality. Subfertility may also be influenced by lifestyle factors, age, or underlying health conditions. The progression of subfertility can vary widely, with some individuals eventually achieving pregnancy naturally over time, while others may require medical intervention. Understanding and addressing the underlying causes can be crucial in managing this condition.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506694-35-00Protocol codeP-CCROSSEstimated enrolment60 patientsSponsorUniversitair Ziekenhuis Gent

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