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Study on the Effect of Ovarian Stimulation with Follitropin Delta, Triptorelin, and Progesterone in Women with Infertility of Advanced Age

Registered 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 studying infertility in women of advanced age. The study will explore the effects of different intensities of ovarian stimulation on the development of healthy embryos. The medications being used in this study include follitropin delta, which is administered as a solution for injection, triptorelin, also given as an injection, and progesterone, which is taken orally in capsule form. The purpose of the study is to compare the outcomes of two different doses of follitropin delta to see how they affect the number of healthy embryos produced.

Participants in the study will receive either 15 micrograms or 20 micrograms of follitropin delta. The study will monitor the number of healthy embryos, known as euploid embryos, that develop. The trial will also look at other factors such as the total dose of medication used, the number of eggs retrieved, and various hormone levels during the process. The study aims to provide insights into the best approach for ovarian stimulation in women who are undergoing fertility treatments.

The trial will involve a series of injections and oral medications over a period of time, with regular monitoring to assess the development of embryos. The study will help determine the most effective treatment plan for women experiencing infertility, particularly those who are older and seeking to improve their chances of having a successful pregnancy. The findings from this study could lead to better treatment options for women facing similar challenges.

The research process

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

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, body mass index (BMI), and levels of anti-Müllerian hormone (AMH).

  2. Step 2

    Medication administration

    The first medication, triptorelin, is administered as a subcutaneous injection. This medication is used to prepare the body for ovarian stimulation.

    Following triptorelin, follitropin delta is administered. This is also a subcutaneous injection and is given in doses of either 15 micrograms or 20 micrograms daily, depending on the assigned group. This medication stimulates the ovaries to produce eggs.

    The duration of follitropin delta administration is determined by the response of the ovaries, monitored through regular check-ups.

  3. Step 3

    Monitoring and adjustments

    Regular monitoring of hormone levels and ovarian response is conducted. This includes checking estradiol, progesterone, follicle-stimulating hormone (FSH), and luteinizing hormone (LH) levels.

    Adjustments to medication dosage may be made based on these results to optimize ovarian response.

  4. Step 4

    Egg retrieval

    Once the ovaries have responded adequately, a procedure is scheduled to retrieve the eggs. This involves a minor surgical procedure to collect the eggs from the ovaries.

  5. Step 5

    Embryo development

    The retrieved eggs are fertilized in a laboratory setting. The development of embryos is closely monitored, with specific attention to the formation of blastocysts, which are embryos that have developed to a specific stage.

    Embryos are evaluated for quality and genetic normalcy, known as euploidy, to determine their suitability for implantation.

  6. Step 6

    Embryo transfer

    Selected embryos are transferred to the uterus. This step is crucial for achieving pregnancy.

    The number of embryos transferred and the timing of the transfer are based on the quality and development stage of the embryos.

  7. Step 7

    Pregnancy monitoring

    Following embryo transfer, regular monitoring is conducted to confirm pregnancy. This includes ultrasound scans to visualize gestational sacs and confirm ongoing pregnancy.

Who can join the trial?

5 criteria

  • Women who are unable to become pregnant naturally, known as infertility, and need help through a process called IVF (In Vitro Fertilization).
  • Women who are going through a process called preimplantation genetic screening, which checks embryos for genetic issues before pregnancy.
  • Women who are between the ages of 38 and 41 years old.
  • Women with an AMH (Anti-Müllerian Hormone) level between 1.5 and 3.5 ng/ml. This hormone helps to understand the number of eggs a woman has. The test result should be from the past year.
  • Women with a BMI (Body Mass Index) between 18.5 and 30. BMI is a measure that uses height and weight to estimate body fat.

Who cannot join the trial?

4 criteria

  • Women who are not experiencing infertility cannot participate. Infertility means having difficulty getting pregnant.
  • Women who are not in the advanced age group specified for the study cannot participate. This study is focused on women of a certain age.
  • Men cannot participate in this study, as it is only for women.
  • Individuals who are considered part of a vulnerable population cannot participate. A vulnerable population includes people who might need special protection or care.
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Investigated drugs

Follitropin-delta is a medication used in this trial to stimulate the ovaries. It helps in the development of multiple eggs in women who are undergoing fertility treatments. The trial is comparing two different intensities of this medication to see how it affects the quality of embryos in women of advanced age.

What is already known about the treatment

Follitropin Delta – This medication is administered via subcutaneous injection and is used in fertility treatments. It is currently being studied in clinical trials to assess its effectiveness in producing euploid embryos in women of advanced age undergoing fertility treatments. The main therapeutic indication for follitropin delta is to stimulate the ovaries to produce multiple eggs, which is crucial in assisted reproductive technologies like in vitro fertilization (IVF). At the molecular level, it works by mimicking the natural follicle-stimulating hormone (FSH) in the body, binding to FSH receptors on the ovaries to promote the growth and maturation of ovarian follicles. It is classified pharmacologically as a gonadotropin.

Investigated diseases

Infertility – Infertility is a condition where an individual or couple is unable to conceive after a year of regular, unprotected sexual intercourse. It can affect both men and women and may result from various factors, including hormonal imbalances, structural issues, or lifestyle factors. In women, infertility may be due to problems with ovulation, fallopian tubes, or the uterus. In men, it often involves issues with sperm production or function. The condition can be temporary or permanent, depending on the underlying cause. Infertility can lead to emotional stress and may require medical intervention to achieve pregnancy.
Trial detailsLast updated 9 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507028-22-00Protocol codeFSD-INO-2023-14Estimated enrolment110 patientsSponsorSantiago Dexeus Font Fundacio Privada

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