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Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer

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ClinicalTrials.gov Identifier: NCT02189369
Recruitment Status : Unknown
Verified March 2017 by Carlos Simon, Igenomix.
Recruitment status was:  Recruiting
First Posted : July 14, 2014
Last Update Posted : March 7, 2017
Sponsor:
Information provided by (Responsible Party):
Carlos Simon, Igenomix

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infertility Other: Day 3 embryo transfer Other: Day 5 embryo transfer Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : February 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Day 3 embryo-Own-above cutoff
Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates
 Other: Day 3 embryo transfer
Extraction of endometrial fluid, analysis of prostaglandine and Day 3 embryo transfer
Experimental: Day 5 embryo-Own-above cutoff
Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates
 Other: Day 5 embryo transfer
Extraction of endometrial fluid, analysis of prostaglandine and Day 5 embryo transfer
Experimental: Day 3 embryo-Donor-above cutoff
Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates
 Other: Day 3 embryo transfer
Extraction of endometrial fluid, analysis of prostaglandine and Day 3 embryo transfer
Experimental: Day 5 embryo-Donor- above cutoff
Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates
 Other: Day 5 embryo transfer
Extraction of endometrial fluid, analysis of prostaglandine and Day 5 embryo transfer
Experimental: Day 3 embryo-Donor-lower cutoff
Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates
 Other: Day 3 embryo transfer
Extraction of endometrial fluid, analysis of prostaglandine and Day 3 embryo transfer
Experimental: Day 5 embryo-Donor-lower cutoff
Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates
 Other: Day 5 embryo transfer
Extraction of endometrial fluid, analysis of prostaglandine and Day 5 embryo transfer
Experimental: Day 3 embryo-own-lower cutoff
Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates
 Other: Day 3 embryo transfer
Extraction of endometrial fluid, analysis of prostaglandine and Day 3 embryo transfer
Experimental: Day 5 embryo-own-lower cutoff
Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates
 Other: Day 5 embryo transfer
Extraction of endometrial fluid, analysis of prostaglandine and Day 5 embryo transfer


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Implantation rate [ Time Frame: 15 days ]
    We will reffer a correlation between the prostaglandin results and the implantation rate.

  2. Pregnancy rate [ Time Frame: 15 days ]
    We will reffer a correlation between the prostaglandin results and the implantation rate.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189369


Contacts
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Contact: Carlos Gómez, MA +34670506469 carlos.gomez@igenomix.com

Locations
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Spain
Fundación IVI Recruiting
Valencia, Spain, 46015
Contact: Carlos Gómez, Ma    +34670506469    carlos.gomez@igenomix.com   
Principal Investigator: Carlos Simón, MD, PhD         
Sub-Investigator: Felip Vilella, PhD         
IVI Valencia Recruiting
Valencia, Spain, 46015
Contact: Carlos Gómez, MA       carlos.gomez@igenomix.com   
Principal Investigator: Carlos Simón, MD, PhD         
Sub-Investigator: Marcos Meseguer, PhD         
Sub-Investigator: Sergio Cabanillas, MD         
Sponsors and Collaborators
Igenomix
Investigators
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Principal Investigator: Carlos Simon, MD PhD Fundación IVI
More Information
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Responsible Party: Carlos Simon, Dr. Carlos Simón, Igenomix
ClinicalTrials.gov Identifier: NCT02189369    
Other Study ID Numbers: 1311-FIVI-135-CS
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: March 7, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female