Evaluating the Endometrial Factors in Women with Previous Implantation Failures
A Multicenter, Prospective, Non-selection Study for Endometrial Receptivity Analysis Test in Patients with Previous Implantation Failures
This study is testing how certain factors in the lining of the uterus affect women who have had trouble getting pregnant before, to help improve their chances of success with IVF treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 738 (estimated) |
| Ages | 18 Years to 41 Years |
| Sex | Female |
| Sponsor | Igenomix Industry-sponsored |
| Locations | 12 sites (Phoenix, Arizona and 11 other locations) |
| Trial ID | NCT06097559 on ClinicalTrials.gov |
What this trial studies
This observational study aims to enhance understanding of the endometrial factors affecting infertility in women who have experienced previous implantation failures. It utilizes the Endometrial Receptivity Analysis (ERA®) to determine the optimal window of implantation and the Endometrial Microbiome Metagenomic Analysis (EMMA®) to assess the endometrial microbiome's impact on reproductive outcomes. Participants will undergo standard IVF/ICSI treatments while their endometrial receptivity and microbiome are evaluated to inform personalized embryo transfer decisions.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 41 with a history of previous failed embryo transfers and at least one viable embryo available for transfer.
Not a fit: Patients with significant endometrial pathology or those who have undergone recent intrauterine device placement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved embryo implantation rates and better reproductive outcomes for women facing infertility.
How similar studies have performed: Previous studies utilizing similar approaches to assess endometrial receptivity and microbiome effects on implantation have shown promising results, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Study ICF signature. * Female age between 18 and 41 years (both included). * IVF/ICSI (own or donated gametes) patients with ≥1 previous failed euploid/low-range mosaic embryo transfer(s) or ≥2 previous failed transfers with non-tested good quality embryos. (ROPA method is allowed). * ≥1 PGT-A tested euploid/low-range mosaic blastocyst (day 5/6) available to be transferred (SET or DET according to medical recommendation). * BMI 18.0 - 30.0 Kg/m2. * Negative serological tests for HIV, HBV, HCV, RPR. Exclusion Criteria: * No HRT in the biopsy and/or the embryo transfer cycle. * Intrauterine device (IUD) carriers within 3 months before sample collection. * Surrogate pregnancy (in those countries where it is allowed). * Adenomyosis or any pathological finding affecting the endometrial cavity such as polyps/sub-mucosal myomas, intramural myomas \> 4 cm, or hydrosalpinx. (Note: Patients are allowed to participate if the pathology is previously operated at least 3 months before the endometrial samples are obtained). * Recurrent Pregnancy Loss (RPL ≥2 previous intrauterine miscarriages). * Active endometritis and salpingitis at the moment of the inclusion. * Endometriosis stage \> I (stages II, III and IV) according to ASRM classification. * Atrophic endometrium (\< 6 mm) in the ERA® and/or embryo transfer cycle. * Endometrial receptivity test and/or microbiome test done before ICF signature. * Preimplantation Genetic Testing for Chromosomal Structural Rearrangements (PGT-SR) or Preimplantation Genetic Testing for Monogenic Disorders (PGT-M) concomitant indications. * DuoStim IVF protocol (double ovarian stimulation and two egg retrievals in the same ovarian cycle). * Any illness or medical condition that is unstable or which, according to medical criteria, may put at risk the patient's safety and her compliance in the study.
Where this trial is running
Phoenix, Arizona and 11 other locations
- Arizona Center for Fertility Studies — Phoenix, Arizona, United States (Recruiting)
- In Vitro Buenos Aires — Buenos Aires, Argentina (Recruiting)
- Number 1 Fertility — Melbourne, Victoria, Australia (Not_yet_recruiting)
- Nilo Frantz - Centro de Reprodução Humana — Boa Vista, Porto Alegre, Brazil (Not_yet_recruiting)
- The Fertile Group — Panama City, Panama (Recruiting)
- Inmater — San Borja, Lima, Peru (Recruiting)
- Ovoclinic Marbella — Marbella, Málaga, Spain (Recruiting)
- Ovoclinic Madrid — Madrid, Spain (Recruiting)
- URE Centro Gutenberg — Málaga, Spain (Recruiting)
- Vida Recoletas Sevilla — Sevilla, Spain (Not_yet_recruiting)
- Vida Recoletas Valladolid — Valladolid, Spain (Recruiting)
- Lister Fertility Clinic at The Portland Hospital — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Maria Ruiz, MSc — Igenomix
- Study coordinator: Carlos Gomez, BSc MSc
- Email: carlos.gomez@igenomix.com
- Phone: +34963905310
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.