Implantation complication – Trials in Disease

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Ongoing Clinical Trials for Implantation Complication

There is currently 1 ongoing clinical trial investigating treatment options for implantation complications, specifically focused on recurrent implantation failure in women undergoing fertility treatment. The trial is being conducted in France and is evaluating a medication called certolizumab pegol to help improve pregnancy outcomes.

Clinical trial locations

Study on Certolizumab for Women with Unexplained Recurrent Implantation Failure

This trial is investigating whether certolizumab pegol can help women who have experienced recurrent implantation failure achieve a successful pregnancy. Recurrent implantation failure occurs when good-quality embryos fail to implant in the uterus after multiple attempts during in vitro fertilization (IVF) treatment, despite seemingly good conditions.

Main inclusion criteria:

  • Women aged 18 to 40 years
  • Experiencing infertility due to unknown reasons, male partner issues, or fallopian tube problems
  • Having unexplained recurrent implantation failure, defined as not achieving pregnancy after at least three attempts with good-quality embryos
  • Must be part of the French social security system
  • Must provide informed consent to participate

Main exclusion criteria:

  • Women under 18 years of age
  • Women without a history of recurrent implantation failure
  • Men
  • Individuals considered part of vulnerable populations, such as those with certain disabilities requiring special research protections

Focus and goal of the trial:

The primary goal is to determine if certolizumab pegol can improve the chances of achieving a clinical pregnancy compared to placebo. A clinical pregnancy is confirmed when a heartbeat is detected on ultrasound around five weeks and six days of pregnancy. The study will also track important secondary outcomes including live birth rates, miscarriage rates, and any potential side effects or complications during pregnancy.

Participants will receive either certolizumab pegol or a placebo through an injection under the skin. The treatment involves a dose of 200 mg of certolizumab pegol administered using a pre-filled syringe. Throughout the study, regular monitoring will include ultrasound scans and health assessments to evaluate the response to treatment and ensure participant safety.

Investigational drug:

Certolizumab pegol is the medication being tested in this trial. It works by blocking a protein called tumor necrosis factor (TNF), which is involved in inflammation in the body. Researchers believe that by reducing inflammation, certolizumab pegol may improve the conditions needed for successful embryo implantation. This medication is classified as a TNF inhibitor and is currently approved for other inflammatory conditions, but its use in treating recurrent implantation failure is being investigated through this research.

The trial is expected to continue until April 2029, allowing researchers to collect comprehensive data on both the short-term and long-term outcomes of the treatment.

Summary

Currently, there is one active clinical trial addressing implantation complications, specifically focused on unexplained recurrent implantation failure in women undergoing fertility treatment. The trial is being conducted in France and represents an important effort to find effective treatments for women who have experienced multiple unsuccessful embryo transfers.

The study focuses on certolizumab pegol, a medication that works by reducing inflammation in the body. This approach is based on the theory that inflammation may play a role in preventing successful embryo implantation. By testing this medication in a controlled trial setting, researchers hope to provide new treatment options for women facing this challenging condition.

The trial’s design includes careful monitoring of both safety and effectiveness, with outcomes measured not just by initial pregnancy achievement but also by live birth rates and overall pregnancy health. The study is expected to provide valuable insights over the coming years as it continues through 2029.

Ongoing Clinical Trials on Implantation complication

  • Study on Certolizumab for Women with Unexplained Recurrent Implantation Failure

    Not yet recruiting

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    Investigated diseases:
    France

Connected medications: