Not recruiting

Study on Infertility Risk from Chemotherapy in Young Breast Cancer Patients Using Follitropin Beta and Follitropin Alfa for Egg/Embryo Preservation

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 young women with breast cancer who are undergoing treatment with chemotherapy. The study aims to explore the effectiveness of preserving fertility through a process called oocyte or embryo cryopreservation. This involves freezing eggs or embryos for future use. The trial will use two medications, Follitropin Beta and Follitropin Alfa, which are proteins that help stimulate the ovaries to produce eggs. These medications are administered through a small injection under the skin.

The purpose of the study is to evaluate how well this fertility preservation method works in terms of the number of mature eggs that can be successfully frozen. Participants will undergo a controlled ovarian stimulation process, which is a way to encourage the ovaries to produce multiple eggs. The study will monitor the quality and number of eggs and embryos that can be preserved. It will also assess the safety of the procedures and any potential impact on the timing of cancer treatment.

Throughout the study, the participants' ovarian reserve, which is the capacity of the ovaries to produce eggs, will be evaluated. This is done by measuring levels of a hormone called AMH and counting the number of small follicles in the ovaries. The study will also look at the effects of chemotherapy on fertility, such as the risk of chemotherapy-induced menopause. The trial will follow participants for up to ten years to track pregnancy outcomes and overall health. This research aims to provide valuable insights into preserving fertility for young women undergoing cancer treatment.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of breast cancer, and planned chemotherapy.
Informed consent is required to participate in the study.
Step 2
Initial assessment
An initial assessment of ovarian reserve is conducted. This involves measuring the level of Anti-Müllerian Hormone (AMH) and counting the Antral Follicle Count (AFC).
Eligibility for controlled ovarian stimulation is determined based on sufficient ovarian reserve, defined as AMH ≥ 6 pmol/l or AFC ≥ 6 follicles.
Step 3
Controlled ovarian stimulation
Controlled ovarian stimulation is initiated to prepare for oocyte retrieval. This involves the administration of medications such as follitropin beta or follitropin alfa.
These medications are administered via subcutaneous injection. The dosage and frequency are determined by the healthcare provider based on individual response.
Step 4
Oocyte retrieval
Oocyte retrieval is performed to collect mature eggs. The quality of the retrieval is evaluated based on the number of mature oocytes that can be vitrified (frozen).
The procedure is monitored for safety, and any adverse effects are assessed over the following month.
Step 5
Cryopreservation
The retrieved oocytes or embryos are cryopreserved for future use. This process involves freezing the eggs or embryos to preserve fertility.
The total number of embryos and oocytes preserved, as well as the rate of top-quality embryos, are documented.
Step 6
Follow-up and evaluation
The impact of the fertility preservation program on the timing of chemotherapy is evaluated. A delay in starting chemotherapy is noted if it begins more than 60 days after surgery.
The effects of chemotherapy on ovarian function are monitored, including any instances of chemotherapy-induced amenorrhea or premature ovarian failure.
Step 7
Long-term monitoring
Long-term monitoring includes tracking pregnancies and their outcomes over a 10-year period after chemotherapy or until the age of 43.
Disease-free survival is assessed from the date of surgery until any relapse or death, with data collected at follow-up visits.

Who can join the trial?

7 criteria

Women with newly diagnosed breast cancer confirmed by a test called a histological test, regardless of the cancer's grade, size, lymph node involvement, type, or specific markers like HR and HER2.
Age between 18 and 38 years old.
Plan to receive a specific type of cancer treatment called adjuvant chemotherapy, which may include drugs like anthracycline and taxane, and possibly Trastuzumab or hormone therapy.
No previous chemotherapy treatment.
Must be part of a public health insurance program.
Must have signed a document agreeing to participate, known as an informed consent form.
For certain procedures, must have a sufficient ovarian reserve, which means having a certain level of a hormone called AMH (at least 6 pmol/l) or a certain number of small sacs in the ovaries called follicles (at least 6).

Who cannot join the trial?

6 criteria

Patients who are not young women with breast cancer cannot participate. This study is specifically for young women with this condition.
Patients who are not planning to receive adjuvant chemotherapy cannot participate. Adjuvant chemotherapy is additional cancer treatment given after the primary treatment to lower the risk of the cancer coming back.
Patients who are not able to undergo controlled ovarian stimulation cannot participate. Controlled ovarian stimulation is a process where medications are used to stimulate the ovaries to produce multiple eggs.
Patients who are not able to have oocyte or embryo cryopreservation cannot participate. Oocyte or embryo cryopreservation is the process of freezing eggs or embryos for future use.
Patients who are not female cannot participate, as the study is only for female subjects.
Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes individuals who may have limited ability to give informed consent or are at higher risk of being harmed.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

CHRU De Nancy
Responsive
Vandoeuvre Les Nancy, France
Centr Georges Francois Leclerc
Verified
Dijon, France
Institut De Cancerologie De Lorraine
Responsive
Vandoeuvre Les Nancy, France

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Investigated drugs

Oocyte/Embryo Cryopreservation is a procedure used to preserve a woman's eggs or embryos by freezing them. This is done after controlled ovarian stimulation, which involves using medications to stimulate the ovaries to produce multiple eggs. The eggs are then retrieved and can be frozen for future use. This process is particularly important for young breast cancer patients who are about to undergo chemotherapy, as it helps preserve fertility by allowing them to have biological children in the future.

Follitropin Alfa

What is already known about the treatment

Adjuvant Chemotherapy – This treatment is typically administered intravenously and is used as an additional cancer treatment given after the primary treatment to lower the risk of the cancer returning. In medical literature, adjuvant chemotherapy is well-established and widely used, particularly in breast cancer treatment. It is primarily indicated for breast cancer in young women, aiming to eliminate any remaining cancer cells post-surgery. At the molecular level, chemotherapy drugs work by targeting rapidly dividing cells, interfering with their DNA replication or other critical cellular functions, leading to cell death. It falls under the pharmacological classification of antineoplastic agents, which are drugs used to treat cancer.

Investigated diseases

Breast Cancer in Young Women – Breast cancer in young women is a type of cancer that develops in the breast tissue, typically affecting women under the age of 40. It begins when cells in the breast grow uncontrollably, forming a tumor that can often be felt as a lump. This cancer can spread to other parts of the body if not treated. The progression of the disease can vary, with some tumors growing slowly and others more rapidly. Hormonal factors, genetic predispositions, and lifestyle choices can influence its development. Early detection and monitoring are crucial for managing the disease effectively.