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Study on Progesterone for Improving Birth Rates in Couples with Unexplained Infertility Undergoing Mild Ovarian Stimulation and Intrauterine Insemination

Fast replyRegistered 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 the effects of a treatment for couples experiencing unexplained infertility. The treatment being tested is called Utrogestan, which is a soft vaginal capsule containing micronised progesterone. Progesterone is a hormone that plays a crucial role in the menstrual cycle and in maintaining the early stages of pregnancy. The study will also use a placebo, which is a capsule that looks like the real medication but does not contain the active ingredient, to compare the effects of the treatment.

The purpose of the study is to determine if adding progesterone support during a specific phase of the menstrual cycle, known as the luteal phase, can increase the chances of a live birth for couples undergoing a fertility treatment called intra-uterine insemination (IUI) with mild ovarian stimulation. This involves using a medication called FSH to gently stimulate the ovaries. The study will follow participants over a period of six months to observe outcomes such as pregnancy rates, live births, and any side effects experienced during the treatment.

Participants in the study will be monitored for various outcomes, including the number of IUI cycles they undergo, any pregnancies that occur, and the overall impact on their quality of life. The study will also assess the cost-effectiveness of adding progesterone support to the treatment. The findings from this study aim to provide valuable insights into improving fertility treatment outcomes for couples facing unexplained infertility.

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, eligibility is confirmed based on specific criteria such as age, body mass index, and fertility history.

    Participants are informed about the study's purpose, procedures, and potential risks and benefits.

  2. Step 2

    Randomization

    Participants are randomly assigned to either the treatment group receiving progesterone or the placebo group.

    This process ensures that the study results are unbiased.

  3. Step 3

    Treatment administration

    Participants in the treatment group receive Utrogestan 300 mg soft vaginal capsules.

    The medication is administered daily for a specified duration as part of the study protocol.

  4. Step 4

    Monitoring and follow-up

    Participants attend regular follow-up visits to monitor their health and the effects of the treatment.

    Side effects and adherence to the treatment are assessed using a medication diary and a questionnaire.

  5. Step 5

    Evaluation of outcomes

    The primary outcome is the occurrence of pregnancy leading to a live birth within six months after randomization.

    Secondary outcomes include clinical pregnancy rates, miscarriage rates, and quality of life assessments.

  6. Step 6

    Completion of the study

    Participants complete the study after the specified follow-up period.

    Final assessments are conducted to evaluate the overall impact of the treatment on fertility and quality of life.

Who can join the trial?

8 criteria

  • Diagnosis of Unexplained Subfertility, based on national guideline definitions.
  • Hunault score less than 30% (or 30% or more after trying to conceive naturally for at least 6 additional months). The Hunault score is a calculated chance of getting pregnant and having a live birth in the next year.
  • Female age between 18 and 43 years.
  • Female BMI (body-mass index) less than 45 kg/m2. BMI is a measure of body fat based on height and weight.
  • Primary or secondary Subfertility for at least 1 year. Subfertility means having difficulty getting pregnant.
  • Regular menstrual cycles.
  • Total mobile sperm count (TMC) greater than 10 million. TMC is the number of moving sperm in a sample.
  • First MOH-IUI cycle (with gonadotropins), with the intent to receive this treatment for at least six months. MOH-IUI is a fertility treatment involving mild ovarian stimulation and intrauterine insemination.

Who cannot join the trial?

3 criteria

  • Patients who are not experiencing **unexplained subfertility** or **infertility** cannot participate. **Subfertility** means having difficulty getting pregnant, and **infertility** means not being able to get pregnant after a year of trying.
  • Only **females** are eligible to participate. Males cannot participate in this study.
  • Participants must not be part of a **vulnerable population**. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as children, pregnant women, or those with certain disabilities.
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Investigated drugs

FSH (Follicle Stimulating Hormone) is a medication used to help stimulate the ovaries in women who are undergoing fertility treatments. In this trial, FSH is used to encourage the ovaries to produce more eggs than usual, which can increase the chances of pregnancy. It is a key part of the treatment process for women who are trying to conceive through assisted reproductive technologies.

What is already known about the treatment

Luteal Phase Support (LPS) – Luteal Phase Support is typically administered in the form of progesterone, which can be applied as an oral tablet, vaginal gel, or injection. It is currently being studied in the context of fertility treatments, specifically for its role in improving the success rates of intrauterine insemination (IUI) procedures. The main therapeutic indication for LPS is to support the luteal phase of the menstrual cycle, which is crucial for maintaining a pregnancy. At the molecular level, LPS works by supplementing progesterone, a hormone that helps prepare the uterine lining for implantation and supports early pregnancy. Pharmacologically, it is classified as a progestogen, which is a type of hormone therapy used to mimic the effects of natural progesterone.

Investigated diseases

Unexplained Subfertility – Unexplained subfertility is a condition where a couple is unable to conceive after a year of regular, unprotected intercourse, and no specific cause is identified after standard fertility evaluations. The condition involves both partners having normal fertility parameters, yet conception does not occur. It is characterized by the absence of identifiable reproductive issues such as ovulation disorders, tubal blockages, or sperm abnormalities. The progression of unexplained subfertility can vary, with some couples eventually achieving pregnancy naturally over time. The condition can lead to emotional stress and anxiety due to the uncertainty and lack of a clear diagnosis. It is often a diagnosis of exclusion, meaning it is determined after ruling out other potential causes of infertility.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501534-33-00Protocol codeV0001227Estimated enrolment1 008 patientsSponsorUniversitair Medisch Centrum Utrecht

sourced from the EU Clinical Trials Register and site verification

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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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