Status:
COMPLETED
Development of a Microbiome Non-invasive Diagnosis Tool
Lead Sponsor:
Igenomix
Conditions:
Infertility of Uterine Origin
Eligibility:
FEMALE
18-50 years
Brief Summary
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...
Detailed Description
Embryonic implantation is a critical process to the survival of the species that is relatively inefficient, especially in humans. Key elements are the embryo, the maternal endometrium, and the cross-c...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 4 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 25 2020
Estimated Enrollment :
452 Patients enrolled
Trial Details
Trial ID
NCT03330444
Start Date
August 4 2017
End Date
June 25 2020
Last Update
October 9 2020
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
RMA Connecticut
Norwalk, Connecticut, United States, 06861
2
IVF Florida
Margate, Florida, United States, 33063
3
Missouri Center for Reproductive Medicine (MCRM Fertility)
Chesterfield, Missouri, United States, 63005
4
Dominion Fertility
Arlington, Washington, United States, 22203