Study on the Effects of Follitropin Beta and Corifollitropin Alfa for Patients with Subfertility Undergoing ICSI Treatment

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What is this study about?

This clinical trial is focused on studying the treatment of subfertility in women who need Intracytoplasmic Sperm Injection (ICSI) treatment. The study involves the use of medications called Puregon and Elonva, which are solutions for injection. Puregon contains the active substance follitropin beta, and is available in different strengths: 300 IU, 600 IU, and 900 IU. Elonva contains the active substance corifollitropin alfa. These medications are used to help stimulate the ovaries to produce eggs.

The purpose of the study is to find the best dosing of recombinant FSH (follicle-stimulating hormone) after using corifollitropin alfa in women undergoing In Vitro Fertilization (IVF) or ICSI. Participants will receive these medications through subcutaneous injections, which means the medication is injected under the skin. The study will compare different doses to see which one works best in helping women produce eggs for IVF or ICSI.

Throughout the study, researchers will monitor the levels of a hormone called progesterone in the blood on a specific day of the treatment cycle. They will also look at other outcomes, such as the number of eggs retrieved, the rate of clinical pregnancies, ongoing pregnancies, miscarriages, and live births. The study aims to provide valuable information on how to optimize treatment for women undergoing fertility treatments.

1 joining the study

Upon joining the study, eligibility criteria must be met. These include being a female aged between 18 and 40 years, having a body mass index (BMI) of 29 kg/m2 or less, and having regular menstrual cycles.

No hormonal treatment should have been received in the month prior to the start of the treatment cycle. A signed informed consent is required.

2 initial assessment

An initial assessment is conducted to ensure normal hormone levels and a normal ultrasound scan. This includes measuring basal FSH, E2, and progesterone levels on cycle day 2 or 3.

An ultrasound scan is performed to confirm the presence of both ovaries without abnormalities.

3 medication administration

The treatment begins with a subcutaneous injection of Elonva 150 micrograms, a solution for injection containing corifollitropin alfa.

Following this, Puregon is administered. This is a solution for injection containing follitropin beta, available in dosages of 900 IU/1.08 mL, 300 IU/0.36 mL, or 600 IU/0.72 mL. The specific dosage and frequency will be determined by the study protocol.

4 monitoring and evaluation

Throughout the treatment, regular monitoring of hormone levels and ovarian response is conducted. This includes measuring serum progesterone levels on the day of hCG administration.

The number of cumulus-oocyte complexes (COCs) retrieved is recorded, along with other outcomes such as clinical pregnancy rate and live birth rate.

5 completion of the study

The study concludes with the evaluation of primary and secondary endpoints, including the mean serum progesterone level on the trigger day and the number of COCs retrieved.

The study is estimated to end by June 30, 2026.

Who Can Join the Study?

Female age: between 18 and 40 years old
No hormonal pre-treatment within the month before starting the treatment cycle
Signed informed consent
Not more than three consecutive unsuccessful IVF/ICSI cycles since the last ongoing pregnancy
BMI (Body Mass Index) should be 29 or less
For patients 36 years old or younger, body weight should be more than 60 kg
For patients older than 36 years, body weight should be more than 50 kg
Regular menstrual cycles lasting between 26 and 35 days
Basal FSH (Follicle Stimulating Hormone) less than 10 IU/l, basal E2 (Estradiol) less than 60 pg/ml, and basal Progesterone less than 1.5 ng/mL, measured on day 2 or 3 of the treatment cycle
Normal ultrasound scan showing both ovaries without abnormalities within the last 6 months
AFC (Antral Follicle Count) more than 7 and less than 20

Who Cannot Join the Study?

Participants must not have any medical conditions that would make it unsafe for them to take part in the study.
Participants must not be using any medications that could interfere with the study results.
Participants must not have any allergies to the substances used in the study.
Participants must not be pregnant or breastfeeding during the study.
Participants must not have participated in another clinical trial recently.
Participants must not have any serious health issues that could affect their ability to complete the study.
Participants must not have a history of substance abuse.
Participants must not have any mental health conditions that could interfere with their participation.
Participants must not have any conditions that affect their ability to understand the study requirements.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country	Status
Algemeen Ziekenhuis Jan Palfijn Gent	Gent	Belgium
Vrije Universiteit Brussel	Jette	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	24.06.2019

Trial locations

Investigated drugs:

Recombinant FSH is a medication used to stimulate the ovaries to produce multiple eggs in women undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). It is a synthetic form of the natural hormone follicle-stimulating hormone (FSH) and helps in the development of eggs in the ovaries.

Corifollitropin alfa is a long-acting medication used to stimulate the ovaries in women undergoing fertility treatments like IVF or ICSI. It is designed to promote the growth of multiple eggs in the ovaries by mimicking the action of the natural hormone FSH.

Subfertility – Subfertility refers to a reduced level of fertility characterized by an extended time to conceive. It is not the same as infertility, as individuals with subfertility can still achieve pregnancy, but it may take longer than usual. The condition can be due to various factors affecting either or both partners, such as hormonal imbalances, ovulation disorders, or issues with sperm quality. Subfertility often requires medical evaluation to identify underlying causes. In some cases, assisted reproductive technologies like Intra-Cytoplasmic Sperm Injection (ICSI) may be recommended to aid conception. The progression of subfertility depends on the underlying causes and the interventions applied.

Trial ID:

2024-517312-30-00

NCT ID:

NCT03686852

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Follitropin Beta and Corifollitropin Alfa for Patients with Subfertility Undergoing ICSI Treatment

What is this study about?

Who Can Join the Study?

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