Study on Corifollitropin Alfa and Follitropin Beta for Women with Infertility Undergoing Ovarian Stimulation with Medroxyprogesterone Acetate

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What is this study about?

This clinical trial is focused on studying treatments for female infertility. The study will explore the effectiveness of two medications: Corifollitropin alfa and Follitropin beta. These medications are used to stimulate the ovaries to produce eggs, which is an important step in fertility treatments. The trial will involve women who are undergoing a process called pituitary suppression, which is achieved using a medication known as Medroxyprogesterone acetate (MPA). This process helps to prevent early luteinization, a condition where the body starts preparing for pregnancy too early, which can affect the success of fertility treatments.

The purpose of the study is to compare the number of eggs produced and their maturity when using Corifollitropin alfa versus Follitropin beta. Participants in the study will receive one of these medications through injections. The study will monitor the number of total eggs and mature eggs, known as metaphase II (MII) oocytes, that are obtained after the ovarian stimulation process. This will help determine which medication is more effective in producing a higher number of mature eggs.

The study will take place over a period of time, with participants receiving treatment and undergoing regular monitoring to assess the outcomes. The results of this study could provide valuable information for improving fertility treatments for women experiencing infertility. The trial is expected to conclude by March 2025.

1 joining the study

Upon joining the study, the participant will have already signed an informed consent form. This confirms understanding and agreement to participate in the clinical trial.

2 initial assessment

An initial assessment will be conducted to ensure eligibility. This includes confirming age between 18 and 35 years, a regular menstrual cycle of 25 to 35 days, and a body mass index (BMI) between 18 and 28 kg/m².

A medical examination will verify the absence of physical and mental illness, a normal uterus and ovaries, and no polycystic ovaries. An antral follicle count greater than 12 will be confirmed, along with a normal karyotype and negative screening for infectious diseases.

3 medication administration

Participants will receive **medroxyprogesterone acetate (MPA)** to prevent early luteinization. This is part of the preparation for ovarian stimulation.

Following this, participants will be administered either **corifollitropin alfa** or **follitropin beta**. These are solutions for injection used to stimulate the ovaries to produce multiple eggs. The specific dosage and frequency will be determined by the study protocol.

4 monitoring and follow-up

Regular monitoring will occur to assess the response to the medication. This includes ultrasound scans and blood tests to track the development of the ovarian follicles.

The primary goal is to compare the number of total oocytes and mature oocytes obtained after stimulation with the two different medications.

5 completion of the trial

Upon completion of the trial, participants will undergo a final assessment to ensure their well-being and to gather data on the outcomes of the treatment.

The trial is expected to conclude by March 31, 2025.

Who Can Join the Study?

Sign the informed consent form before any trial-related activities begin.
Be between the ages of 18 and 35, including both ages.
Have a regular menstrual cycle lasting between 25 and 35 days, including both numbers.
Be free from any physical or mental illness at the time of donation, as determined by the study doctor.
Have a Body Mass Index (BMI) between 18 and 28, including both numbers. BMI is a measure of body fat based on height and weight.
Have no personal or family medical history of concern, as determined by the study doctor.
Have a normal uterus and ovaries without any organic disease.
Do not have polycystic ovaries, which is a condition where the ovaries contain a large number of harmless cysts.
Have an antral follicle count greater than 12 when both ovaries are counted together at the selection visit. This is a measure of the number of small follicles in the ovaries.
Have a normal karyotype, which means having the normal number and structure of chromosomes.
Test negative for infectious diseases such as Hepatitis B, Hepatitis C, HIV, and Syphilis.
Have normal results in general health tests, including blood count, blood clotting, and biochemistry.

Who Cannot Join the Study?

Participants must not have any medical conditions that could interfere with the study.
Participants must not be using any medications that could affect the study results.
Participants must not have a history of allergic reactions to any of the study medications.
Participants must not be pregnant or breastfeeding.
Participants must not have any significant health issues that could pose a risk during the study.
Participants must not have participated in another clinical trial recently.
Participants must not have any mental health conditions that could affect their ability to participate.
Participants must not have any substance abuse issues.
Participants must not have any conditions that require regular use of certain medications that could interfere with the study.
Participants must not have any other conditions that the study doctors think would make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Ivi Valencia S.L.	Valencia	Spain

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.12.2023

Trial locations

Investigated drugs:

Corifollitropin alfa is a medication used to help stimulate the ovaries to produce eggs. It is often used in fertility treatments to help women produce more eggs than they would naturally. This medication works by mimicking the natural hormones in the body that encourage the ovaries to grow and release eggs. In this trial, it is being tested as an alternative to the usual daily hormone injections to see if it can be just as effective in helping women produce eggs for donation.

Follitropin is another medication used to stimulate the ovaries to produce eggs. Like Corifollitropin alfa, it is used in fertility treatments to help women produce more eggs. This medication is typically given as a daily injection and works by encouraging the ovaries to grow and release eggs. In this trial, it is being compared to Corifollitropin alfa to see which one is more effective in helping women produce eggs for donation.

Medroxyprogesterone acetate (MPA) is a medication used to prevent early luteinization, which is when the body starts preparing for pregnancy too early in the egg donation process. By using MPA, the trial aims to control the timing of the body’s natural processes, ensuring that the eggs are ready for collection at the right time. This helps improve the chances of successfully collecting healthy eggs for donation.

Investigated diseases:

Infertility female

Female infertility – Female infertility is a condition where a woman is unable to conceive after a year of regular, unprotected intercourse. It can result from various factors affecting the reproductive system, including hormonal imbalances, structural issues, or problems with ovulation. The condition may involve irregular or absent menstrual cycles, which can indicate ovulation problems. Structural issues such as blocked fallopian tubes or uterine abnormalities can also contribute to infertility. The progression of female infertility depends on the underlying cause, which may remain stable or worsen over time. Environmental factors, lifestyle, and age can also influence the progression of this condition.

Trial ID:

2023-506908-66-00

Protocol code:

2304-VLC-051-JG

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Corifollitropin Alfa and Follitropin Beta for Women with Infertility Undergoing Ovarian Stimulation with Medroxyprogesterone Acetate

What is this study about?

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