Evaluating a biomarker's ability to predict embryo implantation success
Study to Detect the Predictive Capacity of a Composite Biological Marker in the Success of Embryonic Implantation in Fertilization Treatments in Vitro (IVF): Seedchrony Pilot.
This study is testing if measuring a specific marker in the uterine fluid can help predict whether frozen embryos will successfully implant in women undergoing IVF.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 37 Years |
| Sex | Female |
| Sponsor | Manina Medtech Industry-sponsored |
| Locations | 1 site (Barcelona, Other (Non US)) |
| Trial ID | NCT06259084 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to assess whether the concentration of a specific intrauterine biomarker in the uterine fluid can predict the success of embryo transfer during In Vitro Fertilization (IVF). The study will recruit 80 volunteers undergoing frozen embryo transfer cycles with high-quality blastocysts. Using an investigational device, the biomarker levels will be measured the day before and on the day of embryo transfer, while also collecting various clinical variables related to the IVF cycle. The primary focus is to establish a relationship between the biomarker concentration and the outcome of the embryo transfer.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 37 undergoing their first IVF cycle with high-quality frozen blastocysts.
Not a fit: Patients with severe male factor infertility or certain uterine pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the success rates of embryo transfers in IVF, leading to higher pregnancy rates.
How similar studies have performed: While this approach is exploratory, similar studies evaluating biomarkers in IVF have shown promise, though this specific method is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * First IVF cycle patients * Patients who sign the informed consent form * Patients between 18 and 37 years old. * Patients BMI ≤ 30 * Patients who have frozen blastocysts of good quality (grade A or B) * Patients with negative vaginal and endocervical cultures * Patients with an antimullerian hormone level greater than 1 ng/mL. * IVF patients with an endometrial thickness greater than 7mm with trilaminar pattern on the day of the pre-progesterone visit. * And who meets one of these conditions: 1. Not having had a previous embryo transfer. 2. Have failed only one embryo transfer Exclusion Criteria: * Patients with seminal data of the couple with severe oligozoospermia (sperm concentration \<1 million sperm per ml) or azoospermia (absence of sperm in the ejaculate) * Patients diagnosed with at least one of the following uterine pathologies: endometriosis, cancer, malformations, untreated polyps, or submucous fibroids. * Patients diagnosed with at least one of the following medical pathologies: Polycystic ovary syndrome (PCOS), insulin-dependent diabetes mellitus, Cushing's syndrome, uncorrected thyroid dysfunction, hepatic and/or renal insufficiency, a pathology that contraindicates ovarian stimulation and/or gestation, antiphospholipid syndrome, and autoimmune disease. * Patients who are currently taking any medication other than contraceptive treatments, which may interfere with fertility or menstrual cycle regulation. * Evidence of drug, tobacco, or alcohol abuse or dependence according to medical history or information provided by the patient. * Inadequate understanding (oral and written) of the Spanish language.
Where this trial is running
Barcelona, Other (Non US)
- Vall d'Hebron Hospital — Barcelona, Other (Non US), Spain (Recruiting)
Study contacts
- Principal investigator: Melchor Carbonell, Dr. — Hospital Universitario Vall d'Hebron Passeig de la Vall d'Hebron 119-129. 08035 Barcelona
- Study coordinator: Monica Rodriguez de la Vega, PhD
- Email: monica.delavega@maninamedtech.com
- Phone: +34 934764928
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.