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Study of Follitropin Delta, Triptorelin and Choriogonadotropin Alfa for Ovulation Trigger in IVF with Fresh Transfer in Women with Low Ovarian Reserve

Registered 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 involves women who have difficulty becoming pregnant because of infertility and low ovarian reserve. In an effort to improve the outcome of IVF cycles that use fresh embryo transfer, the trial will compare three ways of triggering ovulation, including the usual hormone called hCG, a combination of hCG plus a newer medication called follitropin delta, and an alternative medicine known as ganirelix acetate. The purpose of the study is to find out whether adding follitropin delta to the standard trigger increases the number of mature eggs, referred to as MII eggs, that can be collected for fertilization.

Participants will go through a normal IVF process, receiving hormone injections to grow multiple follicles, and then be randomly assigned to one of the three trigger groups. After the trigger injection, eggs are retrieved, fertilized in the laboratory, and the resulting embryos are placed back into the uterus in the same cycle. The study follows each woman through egg collection, embryo transfer, and early pregnancy testing, recording how many mature eggs are obtained, the rate of pregnancy, and some laboratory measurements of gene activity in the eggs.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    After joining the study you will sign informed consent and provide medical information needed for the trial.

  2. Step 2

    Start background medication

    You will receive ganirelix acetate as a subcutaneous injection of 0.25 mg. the injection is given under the skin according to the schedule defined by the study.

    You will also receive the meriofert kit, which contains follicle‑stimulating hormone and luteinising hormone, administered as a subcutaneous injection of 75 IU.

  3. Step 3

    Receive test medication according to assigned arm

    If you are assigned to the triptorelin arm, you will be given triptorelin as a subcutaneous injection of 0.2 mg.

    If you are assigned to a follitropin delta arm, you will be given rekovelle as a pre‑filled pen delivering 15 µg of follitropin delta by subcutaneous injection.

    For the ovulation trigger, you will receive ovitrelle as a subcutaneous injection of 250 µg of choriogonadotropin alfa.

  4. Step 4

    Monitoring visits

    You will attend scheduled visits where the study team will check your response to the medication and adjust dosing if required.

  5. Step 5

    Ovulation trigger

    On the day scheduled for ovulation, you will receive the ovulation trigger injection. this may consist of ovitrelle alone or combined with rekovelle depending on the study arm.

  6. Step 6

    Oocyte retrieval

    Approximately 36 hours after the trigger injection, a minor surgical procedure will be performed to collect the eggs (oocytes) from your ovaries.

  7. Step 7

    Fresh embryo transfer

    The mature eggs will be fertilised in the laboratory and the resulting embryos will be placed back into the uterus in a procedure called fresh embryo transfer.

  8. Step 8

    Pregnancy test and follow‑up

    About two weeks after the embryo transfer you will have a blood test to check for biochemical pregnancy, and later visits will assess ongoing pregnancy status.

Who can join the trial?

4 criteria

  • Signed informed consent: you must read and sign a document that explains the study and shows you agree to take part.
  • Age 18 to 42 years: you must be at least 18 years old and not older than 42.
  • Primary infertility: you have never been able to become pregnant after trying for a year or more.
  • Poor ovarian response that fits the POSEIDON criteria: this means your ovaries produce fewer eggs than expected, and you meet the specific definitions doctors use for low egg production.

Who cannot join the trial?

10 criteria

  • Having more than two failed **ovarian stimulation cycles** (tried more than two times to stimulate the ovaries to produce eggs without success).
  • Severe male factor infertility, defined as a **total motile sperm count (TMSC)** of less than 1 million sperm (very low number of moving sperm).
  • Being a woman older than 42 years.
  • Having a **BMI** (body‑mass index) greater than 35, which indicates obesity.
  • Having an extremely low ovarian reserve that meets the Spanish National Health System criteria: **AMH** (anti‑Müllerian hormone) less than 0.3 ng/mL and/or **AFC** (antral follicle count) fewer than 5 (both are tests that measure the number of eggs left in the ovaries).
  • Having already had a healthy child together as a couple.
  • Having any medical condition that **contraindicates pregnancy** (a health problem that makes pregnancy unsafe for you).
  • Being at risk for **ovarian hyperstimulation syndrome (OHSS)**, which can happen if more than 15 **follicles** (small fluid‑filled sacs that contain eggs) are expected on the day the eggs are retrieved.
  • Having had a previous voluntary sterilization, such as **bilateral tubal ligation** (surgical blocking of both fallopian tubes) in the woman or a **vasectomy** (surgical cutting of the male’s sperm‑carrying tubes) in the partner.
  • Having a male partner older than 55 years.
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Investigated drugs

Orgalutran
Orgalutran contains ganirelix acetate, a medication that blocks the body’s natural hormone signals that can cause an egg to be released too early during IVF. In this study it is given to keep the timing of ovulation under control while the ovaries are being stimulated. Decapeptyl diario
Decapeptyl diario contains triptorelin, a drug that mimics the natural hormone GnRH. It is used to initially suppress the body’s hormone production before the stimulation phase starts, helping to create a more predictable environment for egg growth. REKOVELLE
REKOVELLE provides follitropin delta, a type of follicle‑stimulating hormone (FSH). It is given to encourage the ovaries to develop multiple follicles so that several eggs can be retrieved during IVF. In the trial it is tested to see if adding it to the final ovulation trigger improves the number of mature eggs. Ovitrelle
Ovitrelle contains choriogonadotropin alfa, a form of human chorionic gonadotropin (hCG). This medication is used at the end of the stimulation cycle to signal the final maturation of the eggs and to trigger their release so they can be collected for IVF. Meriofert Kit
The Meriofert Kit includes both follicle‑stimulating hormone (FSH) and luteinising hormone (LH). These hormones work together to stimulate the ovaries to grow follicles and to support the later stages of egg development. In the study it is part of the standard background treatment for ovarian stimulation.

What is already known about the treatment

  • Ganirelix acetate

    This medication is given as a subcutaneous injection and works by blocking the receptors for the hormone that normally triggers ovulation. It is an approved GnRH antagonist used in IVF cycles to prevent early ovulation. The drug helps doctors control the timing of egg release. It belongs to the class of GnRH antagonists.

  • Triptorelin

    Triptorelin is administered by subcutaneous injection and acts as a GnRH agonist that first stimulates and then suppresses the pituitary release of hormones needed for ovulation. It is a licensed treatment used in assisted reproduction to control hormone levels before egg retrieval. By managing the hormonal surge, it helps create a more predictable IVF cycle. It is classified as a GnRH agonist.

  • Follitropin delta

    This drug is injected under the skin and is a recombinant form of follicle‑stimulating hormone (FSH) that encourages the growth of ovarian follicles. It is an approved medication for ovarian stimulation in IVF, especially in women with low ovarian reserve. The medication binds to FSH receptors on the ovary, promoting the development of mature eggs. It belongs to the class of FSH analogues.

  • Choriogonadotropin alfa

    Given as a subcutaneous injection, choriogonadotropin alfa is a recombinant hCG that mimics the natural hormone surge that triggers final egg maturation. It is a widely used, approved trigger for ovulation and luteal support in IVF cycles. The drug activates the same receptors as natural LH, causing the release of the eggs. It is classified as an hCG (LH) analogue.

  • Follicle‑stimulating hormone and luteinising hormone (Meriofert Kit)

    This combination product is injected subcutaneously and contains both FSH and LH activity to stimulate the ovaries. It is an approved human menopausal gonadotropin used in IVF to promote the growth of multiple follicles. The FSH component drives follicle development while the LH component supports further maturation and hormone production. It is classified as a gonadotropin therapy.

Investigated diseases

  • Infertility

    Infertility is the inability to achieve a pregnancy after at least one year of regular, unprotected intercourse. It can arise from hormonal imbalances, structural problems, or functional issues within the reproductive system. In women, infertility may be classified as primary (no previous pregnancies) or secondary (after a previous pregnancy). Persistent underlying factors can maintain the condition over time, limiting the chance of natural conception.

  • Diminished ovarian reserve

    Diminished ovarian reserve (low ovarian reserve) describes a reduction in the number and quality of a woman's remaining eggs compared with age‑related expectations. It often presents with irregular menstrual cycles and a reduced response to ovarian stimulation. As the condition progresses, the pool of viable eggs continues to decline, further lowering the likelihood of successful conception.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526292-37-01Protocol codeTriggerbestEstimated enrolment126 patientsSponsorInstituto De Investigacion Sanitaria Fundacion Para La Investigacion Del Hospital Clinico De Valencia-INCLIVA

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