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Study on Certolizumab for Women with Unexplained Recurrent Implantation Failure

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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 effectiveness of a medication called certolizumab pegol in women who experience recurrent implantation failure. Recurrent implantation failure refers to the situation where a woman is unable to achieve a clinical pregnancy after multiple attempts of transferring good-quality embryos. The trial aims to determine if certolizumab pegol can improve the chances of achieving a clinical pregnancy compared to a placebo.

Participants in the study will receive either certolizumab pegol or a placebo through a subcutaneous injection, which means the medication is injected under the skin. The study will monitor the participants over a period to assess the occurrence of a clinical pregnancy, which is confirmed by detecting a heartbeat in an ultrasound scan around five weeks of pregnancy. The study will also observe other outcomes such as live birth rates, miscarriages, and any potential side effects or complications during the pregnancy.

In addition to certolizumab pegol, the study will use sodium chloride as a solution for infusion, which is a common practice in clinical trials to ensure the safety and comfort of participants. The trial is designed to provide valuable insights into whether certolizumab pegol can be a beneficial treatment for women facing unexplained difficulties in achieving pregnancy through embryo transfer. The study is expected to continue until 2029, allowing for comprehensive data collection and analysis.

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 criteria such as age (18-40 years), type of infertility, and history of recurrent implantation failure.

    Consent is required to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to gather baseline health information and confirm eligibility.

    This may include medical history review and physical examination.

  3. Step 3

    Treatment administration

    The treatment involves the administration of certolizumab pegol or a placebo.

    The medication is given as a subcutaneous injection using a pre-filled syringe.

    The dosage is 200 mg of certolizumab pegol.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to the treatment.

    This includes ultrasound scans to check for clinical pregnancy, defined by the presence of cardiac activity at 5 weeks and 6 days of gestation.

  5. Step 5

    Evaluation of outcomes

    Primary outcomes include the clinical pregnancy rate.

    Secondary outcomes include live birth, miscarriage, and any adverse events such as multiple pregnancies or fetal abnormalities.

  6. Step 6

    Completion of the study

    The study is estimated to end by April 30, 2029.

    Final assessments are conducted to evaluate the overall efficacy and safety of the treatment.

Who can join the trial?

5 criteria

  • Women aged between 18 and 40 years old.
  • Experiencing infertility due to unknown reasons, issues with the male partner, or problems with the fallopian tubes.
  • Having **unexplained recurrent implantation failure**, which means not being able to achieve a pregnancy after at least three attempts with good-quality embryos.
  • Must be part of the French social security system, either as a beneficiary or legally.
  • Must have read, understood, and signed a consent form agreeing to participate in the study.

Who cannot join the trial?

4 criteria

  • Women who are not adults cannot participate.
  • Women who do not have recurrent implantation failures cannot participate.
  • Men cannot participate in this study.
  • Individuals who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or people with certain disabilities who may need special protection in research.
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Investigated drugs

Certolizumab is a medication being studied for its potential to help women who have experienced unexplained recurrent implantation failure. The trial aims to see if this medication can improve the chances of achieving a clinical pregnancy. Certolizumab works by targeting specific proteins in the body that are involved in inflammation, which may play a role in implantation failure.

What is already known about the treatment

Certolizumab – Certolizumab is administered as an injection under the skin. It is currently being studied in clinical trials for its effectiveness in treating women with recurrent implantation failures. The main therapeutic indication for certolizumab in this context is to improve the clinical pregnancy rate in women who have unexplained difficulties with embryo implantation. At the molecular level, certolizumab works by blocking a protein called tumor necrosis factor (TNF), which is involved in inflammation. It is classified as a TNF inhibitor, a type of medication that reduces inflammation by targeting specific pathways in the immune system.

Investigated diseases

Recurrent Implantation Failure – This condition occurs when a woman experiences multiple unsuccessful attempts at embryo implantation during in vitro fertilization (IVF) cycles. It is characterized by the failure of embryos to implant in the uterine lining after several IVF procedures, despite the transfer of good-quality embryos. The exact cause of recurrent implantation failure is often unknown, but it may involve factors related to the embryo, the uterine environment, or the interaction between the two. Women with this condition may undergo numerous IVF cycles without achieving a successful pregnancy. The condition can be emotionally challenging and may require further investigation to identify potential underlying issues.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511869-11-00Protocol codeAPHP200031Estimated enrolment161 patientsSponsorAssistance Publique Hopitaux De Paris

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