Study on Ovarian Response in Women with Infertility Using Follitropin Delta and Menotrophin During Assisted Reproductive Technology

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What is this study about?

This clinical trial is focused on studying infertility in women who are undergoing assisted reproductive technologies, such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The trial aims to compare the ovarian response, which is how the ovaries react, after controlled ovarian stimulation using different mixed protocols of two medications: REKOVELLE and MENOPUR. These medications are used to stimulate the ovaries to produce eggs.

The study involves several medications that are administered as injections. REKOVELLE contains the active substance follitropin delta, while MENOPUR contains menotrophin. Other medications used in the study include Fyremadel with the active substance ganirelix, Decapeptyl with triptorelin acetate, and Ovitrelle with choriogonadotropin alfa. These medications are given through subcutaneous injections, which means they are injected under the skin.

Participants in the study will receive these medications over a period of time to stimulate their ovaries. The main goal is to observe the number of fertilized eggs, known as oocytes, after insemination. The study is designed to be randomised, meaning participants are randomly assigned to different treatment groups, and it is controlled, which means it includes a comparison group. The trial is also assessor-blind, meaning the people assessing the outcomes do not know which treatment the participants received, to ensure unbiased results.

1 beginning of the trial

Upon joining the study, you will be randomly assigned to a treatment group. This means you will receive a specific combination of medications as part of the trial.

2 medication administration

You will begin with a medication called REKOVELLE, which is a solution for injection. It is administered through a subcutaneous injection, meaning it is injected under the skin. The dosage is 72 micrograms per 2.16 mL, and it comes in a pre-filled pen for ease of use.

You will also receive MENOPUR, another solution for injection, administered subcutaneously. The dosage and frequency will be determined by the study protocol and your specific treatment group.

3 monitoring and adjustments

Throughout the trial, your response to the medications will be closely monitored. This may involve regular visits to the clinic for blood tests and ultrasounds to assess how your ovaries are responding.

Based on these assessments, the dosage of your medications may be adjusted to ensure the best possible outcome.

4 final medication

Towards the end of the stimulation phase, you will receive a medication called Ovitrelle. This is a solution for injection, administered subcutaneously, and it comes in a pre-filled syringe. The dosage is 250 micrograms per 0.5 mL.

This medication is used to trigger the final maturation of the eggs before they are retrieved.

5 egg retrieval

After the final medication, a procedure will be scheduled to retrieve the eggs from your ovaries. This is typically done under sedation or anesthesia to ensure comfort.

The retrieved eggs will then be fertilized in the laboratory as part of the assisted reproductive technology process.

6 follow-up

Following the egg retrieval, you will have follow-up visits to monitor your recovery and the outcome of the fertilization process.

The primary goal is to assess the number of fertilized eggs, which is a key measure of the trial’s success.

Who Can Join the Study?

Sign the Informed Consent Form before any screening tests. This form explains the study and confirms your agreement to participate.
Be in good physical and mental health, as determined by the study doctor, and be willing and able to follow the study rules.
Be a pre-menopausal woman, which means you still have menstrual periods, and be between 18 and 40 years old.
Have been diagnosed with infertility due to blocked fallopian tubes, unexplained reasons, mild endometriosis (stage I/II), or have a partner with male infertility issues. You should be eligible for treatments like in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), using either your partner’s or a donor’s sperm.
Have experienced infertility for at least one year if you are 37 years old or younger, or for at least six months if you are 38 years old or older. This does not apply if you have blocked tubes or severe male infertility issues.
Have regular menstrual cycles that last between 21 and 35 days, which suggests you are ovulating.
Have had a transvaginal ultrasound within the past year showing both ovaries are visible and healthy, with no significant abnormalities like large cysts or enlarged ovaries. Both ovaries should be accessible for egg retrieval.
Have early menstrual cycle (day 2-4) blood test results showing FSH (Follicle Stimulating Hormone) levels between 1 and 15 IU/L, taken within three months before joining the study.

Who Cannot Join the Study?

Women who are not undergoing assisted reproductive technologies like in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cannot participate. These are medical procedures used to help with fertility.
Men cannot participate in this study.
Individuals who are not considered part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Azienda Provinciale Per I Servizi Sanitari	Trento	Italy
Hospital Quironsalud Malaga	Malaga	Spain
Ginefiv S.L.	Madrid	Spain

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	01.12.2022
Spain	Not recruiting	01.12.2022

Trial locations

Investigated drugs:

REKOVELLE is a medication used to help stimulate the ovaries in women who are undergoing fertility treatments. It works by encouraging the ovaries to produce more eggs, which can then be collected and used in assisted reproductive technologies like in vitro fertilization (IVF). This medication is part of a group of treatments known as gonadotropins, which are hormones that play a key role in the reproductive process.

MENOPUR is another medication used in fertility treatments to stimulate the ovaries. It contains hormones that help the ovaries produce multiple eggs during a woman’s menstrual cycle. This is important for assisted reproductive technologies, as having more eggs available can increase the chances of a successful pregnancy. MENOPUR is also a type of gonadotropin, similar to REKOVELLE, and is often used in combination with other fertility medications to enhance their effectiveness.

Investigated diseases:

Infertility female

Infertility in women undergoing assisted reproductive technologies (ART) such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle – Infertility in women undergoing ART refers to the inability to conceive naturally, leading to the use of medical techniques like IVF or ICSI to achieve pregnancy. This condition involves challenges in the natural fertilization process, where the egg and sperm may not meet or fertilize effectively. In IVF, eggs are retrieved from the ovaries and fertilized with sperm in a laboratory setting, while ICSI involves the direct injection of a single sperm into an egg. The progression of this condition often involves multiple cycles of ART to increase the chances of successful fertilization and implantation. The process requires careful monitoring of ovarian response and the development of embryos before transfer to the uterus.

Trial ID:

2022-500308-23-00

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Ovarian Response in Women with Infertility Using Follitropin Delta and Menotrophin During Assisted Reproductive Technology

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