Development of a Microbiome Non-invasive Diagnosis Tool
Completed
Conditions studied: Infertility of Uterine Origin
In brief
Although the endometrium tissue has been traditionally considered free of bacteria, recent studies have documented the presence of an endometrial microbiome. In a pilot study conducted by our research team, the microorganisms present in the endometrium were analysed in samples of endometrial fluid (EF) using next generation sequencing (NGS).Consistent with previously published studies, in normal conditions the endometrium is mainly composed of different species of the genus Lactobacillus. It was further noted that the presence of other pathogenic bacteria such as Streptococcus, and/or Gardnerella may alter the endometrial microbiome and can disrupt the uterine environment, affecting implantation rates and pregnancy success. This project aims to validate the microbiome found in the endometrium of women of reproductive age and try to corroborate the relationship between the endometrial microbiome and the reproductive outcomes in patients undergoing assisted reproduction treatment (ART). The use of Endometrial Receptivity Analysis (ERA) tool, together with the analysis of the endometrial flora before the embryo transfer will allow to evaluate the impact of the presence of endometrial pathogens on implantation in receptive patients. Therefore, the focus of this project is the development and clinical validation of a non-invasive diagnosis tool to analyse the microbiota, adding the microbiome study to the ERA analysis.
Key facts
- Study ID
- NCT03330444
- Run by
- Igenomix
- People needed
- 452
- Starts
- 2017-08-04
- Expected to finish
- 2020-06-25
- Last updated by the study team
- 2020-10-09
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Patients in In Vitro Fertilization (IVF) / IntraCytoplasmic Sperm Injection (ICSI) or OVODON with indication of ERA, with or without Preimplantation genetic screening (PGS) indication, which receive embryo transfer with frozen blastocyst stage embryos (day 5/day 6) on a hormone replacement therapy (HRT) cycle.
- Maternal Age: ≤40 years (IVF/ICSI patients)
- Maternal Age: ≤50 years (OVODONATION patients)
- Body Mass Index (BMI): 18.5 - 30 kg / m2 (both inclusive)
- Negative serological tests for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), Rapid plasma reagin (RPR) for syphilis
- Women with regular menstrual formula (3-4 / 26- 35 days)
- Sperm concentration: > 2 million spermatozoa/ml
You may not qualify if…
- Patients who are Intra-Uterine Device (IUD) carriers in the last 3 months
- Patients who have taken prescribed antibiotics in the last 3 months before the sample collection. (May be accepted those cases where the patient has received previous prophylactic antibiotics to ovarian puncture in the stimulation cycle, according to the standard clinical practice of the centre. The administration of this antibiotic should be at least 1 month before the sample collection).
- Adnexal or uterine pathologies as uterine malformations that may affect the implantation rate (e.g: Polyps, intramural myoma ≥ 4cm or submucosal, septum, hydrosalpinx, etc). Patients affected (before or after of their inclusion) with any of the previously described pathologies, will be allowed to participate in this study as long as they are surgically treated before any study procedure.
- Existence of bacterial, fungal or viral infections severe or uncontrolled that, in the opinion of the principal investigator, could interfere with the patient's participation in the study or the assessments of the study results.
- Any illness or medical condition that is unstable or can put patient safety at risk and compliance in the study.
Where it is running
- RMA Connecticut — Norwalk, Connecticut, United States
- IVF Florida — Margate, Florida, United States
- Missouri Center for Reproductive Medicine (MCRM Fertility) — Chesterfield, Missouri, United States
- Dominion Fertility — Arlington, Washington, United States
- Gestanza Medicina Reproductiva — Rosario, Santa Fe Province, Argentina
- Pregna Medicina Reproductiva — Buenos Aires, Argentina
- Pacific Center for Reproductive Medicine — Burnaby, British Columbia, Canada
- oak Clinic Sumiyoshi — Osaka, Osaka, Japan
- Alpha Fertility Center — Petaling Jaya, Selangor, Malaysia
- New Hope Fertility Center — Mexico City, Mexico
- Clinica Fertia — Fuengirola, Malaga, Spain
- ProcreaTec — Madrid, Spain
- Bahçeci Fulya IVF Center — Istanbul, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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