Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Infertility Treatment with Follitropin Alfa and Lutropin Alfa for Women Over 35 with Low Ovarian Response

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for infertility in women over 35 years old who have shown a lower response to fertility treatments in the past. The study involves comparing two different treatment approaches. One group will receive a combination of recombinant follicle-stimulating hormone (rhFSH) and recombinant luteinizing hormone (rhLH), known as Pergoveris, while the other group will receive rhFSH alone, known as Gonal-F. These treatments are part of a protocol that helps prepare the body for ovulation, which is the release of an egg from the ovary.

The purpose of the study is to compare the levels of a hormone called progesterone and the ratio of progesterone to another hormone called estradiol on the day when ovulation is triggered. This is done to see if adding rhLH to the treatment makes a difference in hormone levels and the overall response to the treatment. The study will also look at other factors, such as the number of eggs retrieved, the quality of embryos, and the chances of achieving a pregnancy.

Participants in the study will follow a specific treatment plan over a period of time, which includes receiving injections of the study medications. The study will monitor hormone levels and other indicators at various points to gather information on how the treatments are working. The goal is to find the most effective approach for women who have had a suboptimal response to previous fertility treatments.

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

    Eligibility is determined based on age (35-40 years), antral follicle count, and previous response to ovarian stimulation.

    Consent form is signed, and adherence to the study schedule is confirmed.

  2. Step 2

    Medication administration

    Begin treatment with Pergoveris (300 IU of recombinant follicle-stimulating hormone (rhFSH) and 150 IU of recombinant luteinizing hormone (rhLH)) or Gonal-F (300 IU of rhFSH alone).

    Both medications are administered via subcutaneous injection using a pre-filled pen.

  3. Step 3

    Monitoring and adjustments

    Regular monitoring of hormone levels, including progesterone, estradiol, FSH, testosterone, and LH, on specific days (1, 6, 8, 10) and the final day of oocyte maturation.

    Adjustments to medication dosage may occur based on response.

  4. Step 4

    Ovulation triggering

    Ovulation is triggered when hormone levels and follicle development are optimal.

    The primary endpoint is the measurement of serum progesterone levels and the progesterone-to-estradiol (P4/E2) ratio on this day.

  5. Step 5

    Oocyte retrieval

    Oocytes are retrieved for fertilization.

    The number of oocytes and their quality are assessed.

  6. Step 6

    Embryo development

    Embryos are developed and monitored for quality.

    The number of blastocysts and good-quality embryos is recorded.

  7. Step 7

    Pregnancy assessment

    Clinical pregnancy is confirmed by the presence of an intrauterine gestational sac at 6-7 weeks of gestation.

    Ongoing pregnancy is confirmed by the presence of a gestational sac with cardiac activity at 8-9 weeks.

Who can join the trial?

7 criteria

  • Must be a woman who is part of the POSEIDON group 2. This group includes women with specific characteristics related to their ovarian response.
  • Must be able and willing to sign the Patient Consent Form and follow the study's visit schedule.
  • Must be between the ages of 35 and 40 years old.
  • Must have an Antral Follicle Count (AFC) of 5 or more, or an antimullerian hormone (AMH) level of 1.2 ng/mL or higher. AFC is a test that counts the number of small follicles in the ovaries, and AMH is a hormone that helps assess ovarian reserve.
  • Must have retrieved fewer than 4 or between 4 and 9 oocytes (eggs) in a previous IVF/ICSI cycle with a starting dose of 225 IU or less of any gonadotropin under a GnRH antagonist protocol. IVF/ICSI are types of fertility treatments, and a GnRH antagonist protocol is a specific method used in these treatments.
  • Must have had up to 3 previous ovarian stimulation cycles with a starting dose of 225 IU, where dose adjustments during stimulation did not exceed 300 IU.
  • Must be undergoing ovarian stimulation for IVF/ICSI. Ovarian stimulation is a process to encourage the ovaries to produce multiple eggs.

Who cannot join the trial?

7 criteria

  • Women who are not experiencing infertility cannot participate. Infertility means having difficulty getting pregnant.
  • Women who do not belong to the POSEIDON group 2 are excluded. This group includes women with specific characteristics related to their response to fertility treatments.
  • Women who have not shown a suboptimal response to a previous fertility treatment cycle are excluded. A suboptimal response means that the treatment did not work as well as expected.
  • Women who have not been treated with a starting dose of 225 IU or less of any gonadotropin in a previous cycle are excluded. Gonadotropins are hormones used to stimulate the ovaries.
  • Women who are not following a GnRH antagonist protocol are excluded. This is a specific type of fertility treatment plan.
  • Men cannot participate in this study.
  • Individuals who are considered part of a vulnerable population are excluded. This means people who might need special protection or care.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

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

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Pergoveris

    This medication is a combination of two hormones, recombinant follicle-stimulating hormone (rhFSH) and recombinant luteinizing hormone (rhLH). It is used in this trial to help stimulate the ovaries in women who have a low response to fertility treatments. The goal is to improve the chances of successful ovulation and pregnancy by providing additional hormonal support.

  • Gonal-F

    This medication contains recombinant follicle-stimulating hormone (rhFSH) and is used to stimulate the ovaries to produce eggs. In this trial, it is used alone to compare its effectiveness against the combination treatment with Pergoveris. The aim is to see how well it works in women with low ovarian sensitivity who have not responded well to previous fertility treatments.

What is already known about the treatment

  • Pergoveris

    This medication is administered via injection and is used in fertility treatments. It is currently recognized in medical literature as a combination therapy for women with low ovarian sensitivity, particularly those over 35 years old. The main therapeutic indication is to aid in ovulation for women experiencing infertility. At the molecular level, it works by combining recombinant follicle-stimulating hormone (FSH) and luteinizing hormone (LH) to stimulate the ovaries. It is classified pharmacologically as a gonadotropin.

  • Gonal-F

    This medication is also administered through injection and is used in fertility treatments. It is well-documented in medical literature for its role in stimulating the ovaries in women with fertility issues. The primary therapeutic indication is to promote ovulation in women with infertility. Its mechanism of action involves the use of recombinant FSH to encourage the growth and development of ovarian follicles. It is classified 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 intercourse. It can affect both men and women and may result from various factors, including hormonal imbalances, structural issues, or lifestyle factors. In women, it may be related 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 address the underlying issues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514035-19-00Estimated enrolment120 patientsSponsorSantiago Dexeus Font Fundacio Privada

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.