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Study on GnRH Agonists for Ovulation and Luteal Support in IVF Patients: Comparing GnRH Agonist with hCG and Progesterone

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 individuals undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), which are methods used to help with conception. The study is comparing two different approaches to support the luteal phase, which is a part of the menstrual cycle that occurs after ovulation. The first approach uses a medication called a GnRH agonist to trigger ovulation and support the luteal phase. The second approach, which is the current standard, uses a hormone called hCG to trigger ovulation and supports the luteal phase with progesterone administered vaginally.

The purpose of the study is to see if using the GnRH agonist alone can increase the chances of a live birth compared to the standard method. Participants in the study will receive one of these treatments and will be monitored throughout their IVF or ICSI cycle. The study will track various outcomes, including the rate of live births, the success of embryo implantation, and the occurrence of any pregnancy-related conditions. The medications involved in the study include progesterone, follitropin beta, follitropin alfa, ganirelix, nafarelin, triptorelin, choriogonadotropin alfa, and cetrorelix.

Participants will be given these medications in various forms, such as injections or nasal sprays, depending on the specific treatment protocol they are assigned to. The study aims to provide valuable information on the effectiveness and safety of these treatments in improving the chances of a successful pregnancy and live birth for individuals undergoing IVF or ICSI. The trial will continue until 2027, with the goal of gathering comprehensive data to inform future fertility treatments.

The research process

The trial runs in 8 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, health status, and previous IVF attempts.

    Informed consent is required to participate in the trial.

  2. Step 2

    Initial treatment phase

    Treatment begins with daily administration of recombinant FSH (follicle-stimulating hormone) injections. The dosage ranges from 75 to 450 IU, depending on individual needs.

    This phase aims to stimulate the ovaries to produce multiple eggs.

  3. Step 3

    Ovulation induction

    Ovulation is induced using a GnRH agonist or hCG, depending on the assigned protocol.

    The goal is to trigger the final maturation of the eggs before retrieval.

  4. Step 4

    Egg retrieval

    Eggs are collected from the ovaries for fertilization.

    This procedure is typically performed under sedation or anesthesia.

  5. Step 5

    Embryo transfer

    Fertilized embryos are transferred to the uterus.

    This step is crucial for achieving pregnancy.

  6. Step 6

    Luteal phase support

    Support is provided using either a GnRH agonist or vaginal progesterone, depending on the protocol.

    This phase helps maintain the uterine lining for potential embryo implantation.

  7. Step 7

    Pregnancy monitoring

    Pregnancy is monitored through blood tests and ultrasounds to confirm implantation and development.

    The presence of a gestational sac and cardiac activity are key indicators of a successful pregnancy.

  8. Step 8

    Follow-up and outcomes

    Regular follow-ups are conducted to monitor the health of the pregnancy and any potential complications.

    The primary outcome is the live birth rate, with secondary outcomes including embryo implantation and pregnancy progression.

Who can join the trial?

11 criteria

  • Patients must need conventional **IVF** (In vitro fertilization) or **ICSI** (intracytoplasmic sperm injection) from a partner or donor, as allowed by French law, and approved by a multidisciplinary consultation meeting.
  • Patients must have signed an informed consent form, which means they agree to participate after understanding the study details.
  • Patients must be affiliated with social security, except for AME (State Medical Aid).
  • Patients must be between 18 and 39 years old.
  • This should be the first or second attempt at IVF or ICSI for the patient.
  • Patients must have a **BMI** (Body Mass Index) of less than 35 kg/m2.
  • Patients must have an **AMH** (Anti-Müllerian Hormone) level greater than 1 ng/ml (which is equal to 7 pmol/L) and/or an antral follicle count of 8 or more.
  • Patients must have an AMH level less than 5 ng/ml and/or an antral follicle count of less than 40.
  • Patients must follow an antagonist protocol, whether it is planned or not.
  • Patients must be treated with daily recombinant **FSH** (Follicle Stimulating Hormone).
  • The initial dose of daily recombinant FSH must be between 75 and 450 IU (International Units).

Who cannot join the trial?

3 criteria

  • Patients who are not planning an embryo transfer in the same cycle as their IVF (In vitro fertilization) or ICSI (intracytoplasmic sperm injection) treatment.
  • Patients who are not female, as the study is only for female participants.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • GnRH Agonist

    is used in this trial to trigger ovulation and provide support during the luteal phase. It helps in releasing eggs from the ovaries and supports the early stages of pregnancy by maintaining the uterine lining.

  • hCG

    is used in the trial as a reference protocol to trigger ovulation. It mimics the natural hormone that signals the ovaries to release eggs.

  • Progesterone

    is used in the reference protocol to support the luteal phase. It helps maintain the uterine lining, which is crucial for a successful pregnancy.

What is already known about the treatment

GnRH Agonist – This medication is administered through injection and is used in the context of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) protocols. It is currently being studied in clinical trials to evaluate its effectiveness in increasing live birth rates when used for luteal phase support. The main therapeutic indication is to support the luteal phase in fertility treatments. At the molecular level, GnRH agonists work by initially stimulating and then downregulating the pituitary gland's release of gonadotropins, which helps in controlling the hormonal environment necessary for successful embryo implantation. It is classified pharmacologically as a gonadotropin-releasing hormone agonist.

Investigated diseases

Ovarian Hyperstimulation Syndrome – This condition occurs when the ovaries respond too strongly to fertility medications, leading to swollen and painful ovaries. It can cause symptoms such as abdominal pain, bloating, nausea, and vomiting. In more severe cases, it may lead to rapid weight gain, shortness of breath, and changes in blood pressure. The syndrome is categorized into early and late forms, with early occurring shortly after egg retrieval and late associated with pregnancy. It is important to monitor symptoms closely to manage the condition effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505126-34-00Protocol codeAPHP220667Estimated enrolment652 patientsSponsorAssistance Publique Hopitaux De Paris

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