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Progesterone as an Ovulation Trigger in Women with Infertility

Registered drug
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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 studying Infertility, a condition in which pregnancy does not happen after regular attempts. The treatment being used is progesterone, given as Cyclogest 400 mg óvulos by vaginal use. The purpose of the study is to see whether progesterone given late in the menstrual cycle can help start the process that leads to egg maturation, which is the normal development of an egg before it is collected.

In this study, progesterone is given at a specific time in the cycle. After treatment, the study follows what happens over the next part of the cycle and around the time of egg collection. The study also looks at hormone levels in the blood, including E2 (a form of estrogen), P4 (progesterone), LH (luteinizing hormone), and FSH (follicle-stimulating hormone), which are natural body signals that help control ovulation and egg development.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study treatment day

    On the day of the study trigger, you receive progesterone as a vaginal pessary. The product used is Cyclogest 400 mg.

    The dose is 800 mg in total, given as 2 pessaries of 400 mg each, used by vaginal use.

    The progesterone is given once as the trigger treatment in the late follicular phase, which is the part of the cycle just before ovulation.

  2. Step 2

    12 hours after trigger

    About 12 hours after the progesterone trigger, blood tests are taken to measure hormone levels.

    These hormone levels are E2 (estradiol, a form of estrogen), P4 (progesterone), LH (luteinizing hormone, a hormone that helps trigger ovulation), and FSH (follicle-stimulating hormone, a hormone that helps egg growth).

  3. Step 3

    Egg retrieval morning

    On the morning of egg retrieval, blood tests are taken again to measure E2, P4, LH, and FSH.

    Egg retrieval is the stage when eggs are collected from the ovaries.

  4. Step 4

    Assessment of mature eggs

    After egg retrieval, the number of mature eggs is counted.

    The study looks at the number of mature oocytes, also called MII eggs. MII means the eggs have reached a mature stage.

Who can join the trial?

6 criteria

  • A correctly signed informed consent form must be completed before any study procedure is done. This means the person agrees to take part in the study in writing.
  • The participant must be a woman who is older than 17 years and younger than 34 years at the time of recruitment.
  • The participant must have regular menstrual cycles, meaning periods that come every 25 to 35 days.
  • The participant must be generally healthy and must not have a history of endocrine disorders, which are problems with hormone-producing glands, such as polycystic ovary syndrome (PCOS).
  • The participant must not have a significant systemic disease, meaning an important illness that affects the whole body.
  • The participant must have a body mass index (BMI) between 18.5 and 28. BMI is a measure that uses height and weight to estimate body fat.

Who cannot join the trial?

13 criteria

  • Any ovarian cysts seen on the first ultrasound scan. A cyst is a fluid-filled sac.
  • Untreated hormone problems, including polycystic ovary syndrome (PCOS), uncontrolled thyroid dysfunction (thyroid gland not working properly and not well controlled), and hyperprolactinemia (too much prolactin, a hormone made by the body).
  • Hypogonadotropic hypogonadism or hypergonadotropic hypogonadism, which are conditions where the body does not make the normal signals needed for the ovaries to work properly.
  • Allergy or other medical reason that makes vaginal progesterone unsafe, including allergy to the medicine or its other ingredients.
  • Medical conditions that make progesterone unsafe, such as active deep vein thrombosis (a blood clot in a deep vein), other thromboembolic disorders (conditions where blood clots can travel in the blood), known or suspected estrogen- or progesterone-dependent neoplasia (a tumor that may grow because of these hormones), undiagnosed abnormal genital bleeding (unexplained bleeding from the vagina), porphyria (a rare disorder that affects how the body makes blood-related substances), or severe liver dysfunction (serious liver problems).
  • Abnormal vaginal anatomy, meaning the shape or structure of the vagina makes it impossible to place the vaginal insert correctly or absorb the medicine properly.
  • Any condition that makes vaginal ultrasound or vaginal oocyte retrieval unsafe. Oocyte retrieval means collecting eggs from the ovaries.
  • Active pelvic inflammatory disease (PID), which is an infection in the female reproductive organs.
  • Acute vaginal or cervical infection, meaning a current infection in the vagina or the cervix, which is the lower part of the uterus.
  • Pelvic malignancies, meaning cancer in the pelvic area.
  • Major changes in the pelvic area, such as unusual anatomy or blood vessel problems, if the study doctor thinks egg collection would be too difficult or could cause serious bleeding or injury to nearby organs.
  • Use of hormonal contraceptives such as the pill, patch, or ring, or use of GnRH analogues (medicines that affect hormone signals) within the last month.
  • Participation in another clinical trial or use of an investigational drug (a medicine still being studied) within the last 30 days.
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Investigated drugs

Progesterone is the study treatment used in this trial. It is given through the vagina as a pessary, which is a small medicine that dissolves inside the body. In this study, progesterone is being tested to see whether giving it in the late part of the follicle phase can help trigger the egg to start maturing again and continue the ovulation process.

What is already known about the treatment

Progesterone - Progesterone is a hormone medicine given here as a vaginal pessary (ovule), which is inserted into the vagina so the medicine can be absorbed locally and into the body. It is still widely used in medicine and is well described in medical literature, especially for fertility care, menstrual problems, and support of early pregnancy. It belongs to the progestogen class, and it works by binding to progesterone receptors in cells, which changes how certain genes are turned on or off and helps prepare reproductive tissues for pregnancy-related changes.

Investigated diseases

Infertility - Infertility is the inability to achieve pregnancy after regular unprotected sexual intercourse for a period of time. It may result from problems in ovulation, sperm function, the fallopian tubes, the uterus, or hormone balance. In some cases, it is related to changes in the timing of egg development and release. Its course depends on the underlying cause and may be temporary or long lasting.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523850-15-00Protocol code2504-LIS-054-ANEstimated enrolment10 patients

sourced from the EU Clinical Trials Register and site verification

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