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Effect of Follitropin Delta plus Menotrophin on Embryo Quality in Advanced Age Women with Infertility

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

The study focuses on women who have difficulty becoming pregnant, known as infertility. Participants will receive ovarian stimulation, which means medicines are given to help the ovaries produce eggs. The two medicines used for stimulation are follitropin delta, a hormone that encourages egg growth, and hMG, another hormone that supports egg development. Different groups will receive different amounts of these medicines to see which combination works best for creating healthy embryos.

The main goal of the trial is to compare the quality of embryos, specifically the number of good quality blastocyst embryos, when using the two dosing strategies during a treatment plan that includes PGT-A (a test that checks embryos for genetic abnormalities) and a PPOS protocol (a schedule of hormone injections). Women will be randomly placed into one of the two groups, receive daily injections for several weeks, have regular check‑ups to monitor hormone levels and ovarian response, and then undergo a minor procedure to retrieve the eggs. The collected eggs will be fertilized in the lab, and the resulting embryos will be evaluated for quality.

Throughout the study, researchers will record how many eggs are retrieved, how many develop into mature forms, how many become high‑quality embryos, and the rates of pregnancy and live birth. The information gathered will help determine which medication dose offers the best chances of successful embryo development for women of advanced age undergoing fertility 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.

  1. Step 1

    Start daily ovarian stimulation

    On the first day after joining the study, a daily subcutaneous injection of follitropin delta is given. the dose is either 10 µg or 5 µg depending on the assigned group.

    At the same time, a daily subcutaneous injection of hmg is given. the dose is 150 IU for the group receiving 10 µg of follitropin delta, or 225 IU for the group receiving 5 µg of follitropin delta.

  2. Step 2

    Add daily triptorelin injection

    Each day, a subcutaneous injection of triptorelin 0.2 mg is administered in addition to the ovarian stimulation drugs.

  3. Step 3

    Take oral progesterone capsules

    Each day, an oral capsule containing 200 mg of progesterone (product name seidigestan) is swallowed.

  4. Step 4

    Use vaginal progesterone capsules

    Each day, a soft vaginal capsule containing 200 mg of progesterone (product name utrogestan) is inserted according to the instructions.

  5. Step 5

    Continue medication regimen

    The daily injections of follitropin delta, hmg, and triptorelin, together with the oral and vaginal progesterone capsules, are continued until the study physician determines that ovarian stimulation is complete.

  6. Step 6

    Oocyte retrieval and embryo assessment

    Once stimulation is finished, a procedure is performed to retrieve the eggs. the retrieved eggs are fertilized and the resulting embryos are examined for quality according to the study criteria.

  7. Step 7

    Follow‑up and outcome evaluation

    After embryo assessment, further visits may be scheduled to record pregnancy outcomes and any other study endpoints.

Who can join the trial?

6 criteria

  • Be a patient who has infertility (difficulty getting pregnant) and needs to have in‑vitro fertilization (IVF) treatment.
  • Be scheduled for a cycle that includes preimplantation genetic screening (a test of embryos for genetic problems before they are placed in the uterus).
  • Be at least 38 years old but younger than 42 years old.
  • Have an ovarian reserve measurement within the required range: either an AMH level (a hormone that shows egg supply) between 0.5 and 3.5 ng/ml, or an AFC count (the number of small follicles seen on an ultrasound) between 5 and 20. Test results from the past year are acceptable.
  • Have a BMI (body‑mass‑index, a measure of weight relative to height) between 18.5 and 30 kg/m².
  • Both you and your partner must have a normal karyotype (a chromosome test that shows no major genetic abnormalities).

Who cannot join the trial?

8 criteria

  • You have had a poor ovarian response in the past, meaning you produced three or fewer eggs during a normal IVF stimulation, according to the Bologna criteria (a set of rules doctors use to define low egg response).
  • You have a severe male factor infertility that needs TESE (a procedure where sperm is taken directly from the testicle).
  • You are taking any other medication that could affect the study medicines.
  • You have a medical reason that makes hormonal treatment unsafe for you.
  • You have recently had a serious illness that needs ongoing treatment and could affect your safety or the study results.
  • You have a monogenic disease (a condition caused by a change in a single gene) that would be tested with PGT‑M (pre‑implantation genetic testing for monogenic disorders).
  • You have lab or ultrasound signs of polycystic ovarian syndrome (PCOS), a condition where the ovaries have many small cysts and hormone levels are abnormal.
  • You have endocrinological (hormone‑related) or autoimmune (immune system attacking the body) disorders.
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Investigated drugs

  • REKOVELLE

    is a medication that contains follitropin delta, a type of follicle‑stimulating hormone (FSH). In this study it is given as a daily injection under the skin to help the ovaries grow multiple eggs. The amount of REKOVELLE is adjusted in the two groups to see how different levels of stimulation affect the quality of embryos.

  • MENOPUR

    is a product that contains menotrophin, also known as human menopausal gonadotropin (hMG). It provides both FSH and luteinizing hormone (LH) to further stimulate the ovaries after the initial FSH injection. In the trial MENOPUR is taken each day together with REKOVELLE, and the two groups receive different amounts to compare their impact on embryo quality.

  • Seidigestan

    is a soft‑gel capsule that contains progesterone taken by mouth. Progesterone helps prepare the lining of the uterus and supports the early stages of pregnancy after the eggs are fertilized. In this trial it is used as part of the background medication to maintain a suitable uterine environment.

  • Decapeptyl

    is an injectable form of triptorelin, a medication that acts like a hormone called GnRH. It is used to control the natural hormone surge that can cause premature ovulation. By giving Decapeptyl, doctors can better coordinate the timing of egg retrieval in the study.

  • Utrogestan

    is a soft vaginal capsule that also contains progesterone. It is placed inside the vagina to deliver progesterone directly to the uterus. Like the oral progesterone, it helps support the uterine lining after embryo transfer, ensuring the best chance for implantation.

What is already known about the treatment

  • Rekovelle

    This medication comes as a 72 µg/2.16 mL solution for injection that is used with a pre‑filled pen for sub‑cutaneous administration. It is an approved recombinant follicle‑stimulating hormone (FSH) used to help women with infertility stimulate their ovaries. The drug works by attaching to FSH receptors on ovarian follicles, which encourages the follicles to grow and mature. It belongs to the class of gonadotropins, specifically recombinant FSH.

  • Menopur

    Menopur is supplied as a powder that is mixed with a liquid to create a solution for sub‑cutaneous injection. It is a well‑established human menopausal gonadotropin (hMG) that is approved for treating infertility by stimulating the ovaries. The product contains both FSH and LH activity, providing the hormones needed for follicle development and egg release. It is classified as a urinary‑derived gonadotropin.

  • Seidigestan

    Seidigestan is provided in soft oral capsules containing progesterone. It is a prescription medication that is commonly used for hormone replacement and to support the luteal phase in infertility treatment. The capsule delivers progesterone, which binds to receptors in the uterus to prepare the lining for possible pregnancy. It is classified as a natural progestogen (progesterone).

  • Decapeptyl

    Decapeptyl is a powder that is reconstituted to a solution for sub‑cutaneous injection. It is an approved GnRH agonist used in assisted reproduction to control the timing of hormone release. The drug first stimulates and then suppresses the pituitary gland’s release of LH and FSH, helping to prevent premature ovulation. It belongs to the class of gonadotropin‑releasing hormone agonists.

  • Utrogestan

    Utrogestan is supplied as soft vaginal capsules containing progesterone. It is an approved product for luteal phase support and other infertility‑related uses. When inserted vaginally, the progesterone is absorbed and works by binding to uterine receptors, making the lining ready for embryo implantation. It is also classified as a natural progestogen (progesterone).

Investigated diseases

Infertility - Infertility is the inability to achieve a pregnancy after regular, unprotected intercourse for about 12 months. It can be classified as primary when a woman has never conceived, or secondary when she has previously been pregnant. The condition often develops gradually as ovulation becomes irregular, hormone levels shift, or the number and quality of eggs decline. In many women, especially those of advanced age, the natural decline in egg quantity and quality reduces the chance of successful fertilization over time. The condition remains present until the underlying factors change or assisted reproductive methods are employed.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524761-25-00Protocol codeFSD-QUA-2025-27Estimated enrolment240 patientsSponsorSantiago Dexeus Font Fundacio Privada

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