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Clinical Trials/NCT02189369
NCT02189369
Unknown
Not Applicable

Clinical Validation of a Diagnostic Test Which Measures the Endometrial Prostaglandins Liquid 24 Hours Before Embryo Transfer and That is Capable of Predicting a State of Endometrial Receptivity

Igenomix2 sites in 1 country120 target enrollmentFebruary 2015
ConditionsInfertility

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility
Sponsor
Igenomix
Enrollment
120
Locations
2
Primary Endpoint
endometrial receptivity
Last Updated
9 years ago

Overview

Brief Summary

This clinical validation study is being carried out to validate the efficacy of a test measuring the clinical application of prostaglandins present in the endometrial fluid in patients, 24 hours before the embryonic transfer. This test is capable of predicting endometrial receptivity without the need of performing a biopsy.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
December 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Igenomix
Responsible Party
Principal Investigator
Principal Investigator

Carlos Simon

Dr. Carlos Simón

Igenomix

Eligibility Criteria

Inclusion Criteria

  • Any IVF patient being treated for single or double embryo transfer
  • BMI: 20 - 30
  • Normal ovarian response (7 - 8 ovocitos) in IVF treatment with AFC ≥ 8, (AFC = Antral Follicle Count)
  • Elective embryo transfer
  • Normal uterine cavity
  • Age: ≤ 38 years old for patients with own oocytes; ≤ 50 years old for patients with donated oocytes.

Exclusion Criteria

  • Patients with recurrent miscarriages ( ≥ 2 biochemical miscarriages; ≥ 2 clinical miscarriage)
  • Patients with severe male factor ( ≥ 2\*106 espermatozoides/ml).

Outcomes

Primary Outcomes

endometrial receptivity

Time Frame: 24 hours before embryo transfer

The endometrial samples will be extracted 24 hours before the embryo transfer in order to analyze the quantity of prostaglandins.

Secondary Outcomes

  • Implantation rate(15 days)
  • Pregnancy rate(15 days)

Study Sites (2)

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