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

3 1 1 1

What is this study about?

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.

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 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 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 egg retrieval

Eggs are collected from the ovaries for fertilization.

This procedure is typically performed under sedation or anesthesia.

5 embryo transfer

Fertilized embryos are transferred to the uterus.

This step is crucial for achieving pregnancy.

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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Intercommunal Creteil	Creteil	France

Other Sites

Site Name	City	Country
Assistance Publique Hopitaux De Paris	Paris	France
Centre Hospitalier Sud Francilien	Corbeil Essonnes	France
Assistance Publique Hopitaux De Paris	Bondy	France
Assistance Publique Hopitaux De Paris	Paris	France
Groupe Hospitalier Diaconesses Croix Saint Simon	Paris	France
Centre Hospitalier Intercommunal De Poissy Saint Germain	St Germain En Laye	France
Assistance Publique Hopitaux De Paris	Clamart	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	27.06.2024

Trial locations

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.

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 ID:

2023-505126-34-00

Protocol code:

APHP220667

NCT ID:

NCT06150703

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?