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Study on Infertility: Effects of Choriogonadotropin Alfa, Nomegestrol Acetate, Estradiol Hemihydrate, and Progesterone in Patients Undergoing Frozen Embryo Transfer

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

This clinical trial is focused on studying infertility and involves treatments that support assisted reproduction techniques. The study will use several medications, including choriogonadotropin alfa (also known as FE 999302), nomegestrol acetate combined with estradiol hemihydrate, and progesterone. These medications are used to help with the process of frozen embryo transfer, which is a method where a previously frozen embryo is thawed and transferred to the uterus.

The purpose of the study is to explore whether there are differences in various health aspects of the mother and baby when using different methods of frozen embryo transfer. The study will look at how the presence of the corpus luteum—a temporary structure in the ovaries that produces hormones—affects pregnancies achieved through frozen embryo transfer. Researchers will examine factors such as the function of blood vessels and the placenta, the mother's heart health, and the growth and development of the fetus.

Participants in the study will receive one of the medications mentioned above, or a placebo, and will be monitored throughout their pregnancy. The study will assess various health indicators, including hormone levels and heart function, to understand the impact of the treatments. The study is expected to continue until 2027, with recruitment starting in 2024.

The research process

The trial runs in 5 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, menstrual cycle regularity, and availability of cryopreserved blastocysts from your own gametes.

    The assessment ensures that you meet the criteria for a single embryo transfer.

  2. Step 2

    Medication administration

    You will receive medications to prepare your body for the embryo transfer. These include choriogonadotropin alfa administered subcutaneously, nomegestrol acetate and estradiol hemihydrate administered transdermally, and progesterone administered vaginally.

    The dosage, frequency, and duration of these medications will be explained by the medical team, tailored to your specific needs.

  3. Step 3

    Embryo transfer

    Once your body is prepared, a frozen embryo transfer (FET) is performed. This involves placing the embryo into your uterus.

    The procedure is quick and typically does not require anesthesia.

  4. Step 4

    Monitoring and follow-up

    After the embryo transfer, regular monitoring is conducted to assess the progress of the pregnancy. This includes blood tests and ultrasounds to evaluate maternal and fetal health.

    Specific assessments include measuring plasma concentrations of certain hormones and conducting echocardiography to monitor fetal development.

  5. Step 5

    Completion of trial

    The trial concludes with a final evaluation of maternal and fetal health outcomes. This includes a comprehensive review of the pregnancy and any associated data collected during the study.

    The study aims to understand the impact of the corpus luteum on pregnancies achieved through frozen embryo transfer.

Who can join the trial?

4 criteria

  • Female patients aged 18 to 37 years at the time of egg retrieval and less than 41 years at the time of embryo transfer.
  • Have a regular menstrual cycle that lasts between 24 and 35 days.
  • Have frozen embryos available that were created using your own eggs.
  • Need to have a single embryo transfer.

Who cannot join the trial?

3 criteria

  • Participants must be female.
  • Participants must be within a specific age range.
  • Participants must not belong to a vulnerable population.
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Investigated drugs

Corpus Luteum Secretion Products are natural substances produced by the corpus luteum, a temporary gland in the ovary. These products play a crucial role in pregnancy by supporting the early stages of fetal development. In this clinical trial, researchers are studying how these substances affect the health of the placenta, the growth of the fetus, and the mother's cardiovascular system. The goal is to understand if these natural products can influence the success of pregnancies achieved through frozen embryo transfer.

What is already known about the treatment

  • Estradiol

    This is a natural estrogen hormone administered by intramuscular injection or by mouth in tablet form to prepare the lining of the uterus before the transfer of frozen embryos. Estradiol is routinely used in medicine for fertility treatments and hormone replacement therapy, and it is well documented in the medical literature for its safety and effectiveness. The medication works by binding to estrogen receptors in the reproductive tissues, stimulating the development and thickening of the endometrium to create a favorable environment for embryo implantation. Pharmacologically, estradiol belongs to the class of female sex hormones and is used to mimic the natural menstrual cycle during in vitro fertilization procedures.

  • Progesterone

    This is a natural hormone administered by intramuscular injection, vaginal suppositories or vaginal gel to maintain the lining of the uterus and support early pregnancy after the transfer of frozen embryos. Progesterone is widely used in reproductive medicine and is considered an essential medication in fertility treatments, with numerous studies confirming its vital role in maintaining pregnancy. The medication works by binding to progesterone receptors in the uterus, transforming the endometrium into a nourishing environment for the implanted embryo and preventing uterine contractions that could cause miscarriage. Pharmacologically, progesterone belongs to the category of female sex hormones and mimics the action of the natural corpus luteum that forms after ovulation.

Investigated diseases

Infertility – Infertility is a condition where an individual 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, it may involve problems with ovulation, fallopian tubes, or the uterus. In men, it often relates to issues with sperm production or function. The progression of infertility depends on its underlying causes, which can vary widely among individuals. It may remain stable or change over time, influenced by health, age, and other factors.
Trial detailsLast updated 30 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513600-33-00Protocol codeLUTI StudyEstimated enrolment240 patientsSponsorFundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

sourced from the EU Clinical Trials Register and site verification

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