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Study on Hydroxychloroquine for Women with Recurrent Pregnancy Loss

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 Recurrent Pregnancy Loss, a condition where a woman experiences multiple pregnancy losses before the 22nd week of gestation. The trial is testing the effectiveness of a treatment using Hydroxychloroquine, a medication that is commonly used for other conditions but is being explored here for its potential benefits in improving pregnancy outcomes.

The purpose of the study is to compare the live birth rates between women who receive Hydroxychloroquine and those who receive a placebo. Participants in the study will be randomly assigned to one of these two groups. The study will follow each participant through their pregnancy journey, concluding either after a pregnancy loss or six months after a live birth. If a participant becomes pregnant less than two months after starting the medication or does not achieve pregnancy within a year, they will be replaced by a new participant to ensure the study's goals are met.

The trial aims to include and follow up with 186 women to gather comprehensive data on the effectiveness of Hydroxychloroquine in treating Recurrent Pregnancy Loss. This research could provide valuable insights into new treatment options for women experiencing this challenging condition.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on the criteria of having experienced at least 3 or 4 consecutive pregnancy losses before 22 weeks of gestation, depending on the specific circumstances of the losses.

  2. Step 2

    Randomization and treatment allocation

    Participants are randomly assigned to receive either hydroxychloroquine sulfate or a placebo. This process is double-blind, meaning neither the participant nor the researchers know which treatment is being administered.

  3. Step 3

    Medication administration

    The medication, Plaquenil (hydroxychloroquine sulfate), is provided in the form of film-coated tablets. The route of administration is oral. The specific dosage and frequency are determined by the study protocol and communicated to the participant at this stage.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored throughout the study to assess the impact of the treatment on the live birth rate. This includes regular check-ins and assessments as outlined in the study protocol.

  5. Step 5

    Conclusion of participation

    The trial concludes for each participant after a pregnancy loss or 6 months following a live birth. If a participant becomes pregnant less than two months after starting the medication or does not achieve pregnancy within one year, they may be replaced by a new participant.

Who can join the trial?

4 criteria

  • Women who have experienced **4 or more** confirmed pregnancy losses in a row before reaching 22 weeks of pregnancy, with no known cause for these losses.
  • Women who have experienced **3 or more** confirmed pregnancy losses in a row before reaching 22 weeks of pregnancy, with at least one loss occurring in the second trimester, with no known cause for these losses.
  • Participants must be **female**.
  • Participants must be within the **age range of 18 to 65 years**.

Who cannot join the trial?

3 criteria

  • Only women can participate in the study. Men are not eligible.
  • Participants must be within a specific age range, which is not specified here.
  • Individuals who are considered part of a vulnerable population are not eligible. A vulnerable population includes groups who may have limited ability to protect their own interests, such as children or people with certain disabilities.
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Investigated drugs

Hydroxychloroquine is a medication being studied for its potential to improve the live birth rate in women experiencing recurrent pregnancy loss. It is commonly used to treat autoimmune conditions like lupus and rheumatoid arthritis. In this trial, its role is to determine if it can help increase the chances of a successful pregnancy.

What is already known about the treatment

Hydroxychloroquine – This medication is typically administered orally in tablet form. It is currently being studied in clinical trials for its potential use in treating recurrent pregnancy loss. Hydroxychloroquine is primarily known for its use in treating malaria and autoimmune diseases like lupus and rheumatoid arthritis. It works by modulating the immune system and reducing inflammation, although the exact mechanism in recurrent pregnancy loss is still under investigation. It belongs to the pharmacological class of antimalarial and immunomodulatory agents.

Investigated diseases

Recurrent Pregnancy Loss – This condition is characterized by the occurrence of two or more consecutive pregnancy losses before the 20th week of gestation. It can be caused by a variety of factors, including genetic, anatomical, hormonal, and immunological issues. Women experiencing recurrent pregnancy loss may face emotional and psychological challenges due to repeated miscarriages. The condition often requires a thorough medical evaluation to identify any underlying causes. Understanding the progression of this condition involves monitoring the frequency and timing of pregnancy losses. It is important for affected individuals to receive appropriate support and guidance throughout their reproductive journey.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515579-36-00Estimated enrolment186 patientsSponsorHvidovre Hospital

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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