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Study on the Effects of Progesterone in Different Forms for Women with Infertility

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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 the effects of different doses and ways of giving the hormone progesterone in women who are experiencing female infertility. Progesterone is a hormone that plays a key role in preparing the lining of the uterus, known as the endometrium, for pregnancy. The study will use three forms of progesterone: PRONTOGEST, which is given as an injection into the muscle; Prolutex, which is injected under the skin; and Seidigestan, which is taken as a soft capsule inserted into the vagina.

The purpose of the study is to explore how these different forms and doses of progesterone affect the structure and function of the endometrium during cycles where the endometrium is artificially prepared for pregnancy. This involves looking at how the genes in the endometrium respond to the progesterone treatments. The study will compare the gene activity in the endometrium when using these treatments to the gene activity in a natural cycle without treatment.

Participants in the study will receive one of the progesterone treatments for a period of up to six months. The study will monitor changes in the endometrium by examining gene expression, which is the process by which information from a gene is used to create proteins that affect cell function. The study aims to identify any differences in gene expression between the different progesterone treatments and compare these to a natural cycle. This research could provide valuable insights into optimizing treatment for women with infertility issues.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, an informed consent form must be signed. This form confirms understanding and agreement to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to ensure eligibility. This includes confirming age between 18-35 years, regular menstrual cycles, and overall good health.

  3. Step 3

    Medication administration

    The study involves the administration of progesterone through different methods. The specific method and dosage will be assigned as part of the study protocol.

    The options include: intramuscular injection using PRONTOGEST 100 mg/ml solution, subcutaneous injection using Prolutex 25 mg solution, or vaginal use with Seidigestan 200 mg soft capsules.

  4. Step 4

    Treatment period

    During the treatment period, the assigned medication will be administered according to the study schedule. The frequency and duration will be specified by the study team.

  5. Step 5

    Monitoring and assessments

    Regular monitoring and assessments will be conducted to evaluate the response to the treatment. This includes checking the endometrial structure and function.

  6. Step 6

    Completion of study

    Upon completion of the study, a final assessment will be conducted. This will include evaluating the primary endpoint, which is the gene expression related to progesterone treatment response.

Who can join the trial?

5 criteria

  • All women with no history of **infertility** who agree to participate in the study.
  • Must provide a signed and dated **Informed Consent Form (ICF)**. This is a document that explains the study and confirms your agreement to participate.
  • Age must be between **18 and 35 years old**, inclusive.
  • Must have **regular menstrual cycles**, which means cycles that occur every 22 to 35 days.
  • Must be in **good health** and not have any mental or medical conditions that would prevent participation in the study.

Who cannot join the trial?

8 criteria

  • Participants must not have any other medical conditions that could interfere with the study.
  • Participants must not be using any medications that could affect the study results.
  • Participants must not have a history of allergic reactions to any of the study medications.
  • Participants must not be pregnant or breastfeeding during the study.
  • Participants must not have participated in another clinical trial within the last 30 days.
  • Participants must not have any significant health issues that could pose a risk during the study.
  • Participants must not have a history of substance abuse.
  • Participants must not have any mental health conditions that could affect their ability to participate in the study.
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Investigated drugs

Exogenous Progesterone is a hormone therapy used in this clinical trial to prepare the lining of the uterus, known as the endometrium, for a potential pregnancy. Progesterone is a natural hormone that plays a crucial role in the menstrual cycle and in maintaining the early stages of pregnancy. In this study, different types of progesterone are being tested to see how they affect the structure and function of the endometrium. The medication can be administered in various ways, including vaginally, under the skin (subcutaneous), or into the muscle (intramuscular). The goal is to understand how these different methods of giving progesterone might influence the way the endometrium works, which is important for supporting a pregnancy.

What is already known about the treatment

Exogenous Progesterone – This medication is administered in various forms, including vaginal, subcutaneous, or intramuscular routes, to support the preparation of the uterine lining in women undergoing fertility treatments. Currently, exogenous progesterone is widely recognized in medical literature for its role in enhancing endometrial function, particularly in artificial endometrial preparation cycles. It is primarily used to treat female infertility by preparing the uterus for potential pregnancy. At the molecular level, progesterone works by binding to specific receptors in the uterine lining, promoting changes that make the environment more suitable for embryo implantation. It is classified pharmacologically as a progestin, a type of hormone that mimics the natural hormone progesterone in the body.

Investigated diseases

Female Infertility – Female infertility is a condition where a woman is unable to conceive after a year of regular, unprotected intercourse. It can result from various factors affecting the reproductive system, including hormonal imbalances, structural issues with the reproductive organs, or problems with ovulation. The condition may also be influenced by age, lifestyle, and environmental factors. In some cases, the cause of infertility is unknown, termed unexplained infertility. The progression of female infertility can vary, with some women experiencing temporary infertility, while others may face long-term challenges. The condition can impact emotional and psychological well-being, often requiring support and counseling.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515811-22-00Protocol code1901-VLC-014-ELEstimated enrolment108 patientsSponsorIvi Valencia S.L.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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