Development of a Microbiome Non-invasive Diagnosis Tool

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03330444
• Date of registration: 24/10/2017
• Prospective Registration: No
• Primary sponsor: Igenomix
• Public title: Development of a Microbiome Non-invasive Diagnosis Tool ERA-niMIC
• Scientific title: Development of a Non-invasive Diagnosis Tool for the Analysis of the Microbiota to Improve Reproductive Outcomes in Infertile Patients.
• Date of first enrolment: August 4, 2017
• Target sample size: 452
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03330444
• Study type: Observational

Countries of recruitment

Argentina, Canada, Japan, Malaysia, Mexico, Spain, Turkey, United Kingdom, United States

Contacts

• Name: Carlos Simón, MD PhD
• Affiliation: Igenomix

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

- 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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Infertility of Uterine Origin

Intervention(s)

Procedure: Endometrial biopsy and endometrial fluid collection

Primary Outcome(s)

Development of a new non-invasive diagnosis test of Endometrial Microbiome (EM) in infertile patients [Time Frame: 24 months]

Secondary Outcome(s)

Biochemical pregnancies [Time Frame: 20 weeks]

Ectopic pregnancies [Time Frame: 20 weeks]

Ongoing pregnacy rate [Time Frame: 40 weeks]

Clinical miscarriages [Time Frame: 20 weeks]

Live birth rate [Time Frame: 40 weeks]

Implantation rate [Time Frame: 12 weeks]

Pregnancy rate [Time Frame: 20 weeks]

Secondary ID(s)

IGX1-MIC-CS-17-05

Source(s) of Monetary Support

Please refer to primary and secondary sponsors