Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer

March 6, 2017 updated by: Carlos Simon, Igenomix

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46015
        • Recruiting
        • IVI Valencia
        • Principal Investigator:
          • Carlos Simón, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Marcos Meseguer, PhD
        • Sub-Investigator:
          • Sergio Cabanillas, MD
      • Valencia, Spain, 46015
        • Recruiting
        • Fundacion IVI
        • Contact:
        • Principal Investigator:
          • Carlos Simón, MD, PhD
        • Sub-Investigator:
          • Felip Vilella, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours before embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation rate
Time Frame: 15 days
We will reffer a correlation between the prostaglandin results and the implantation rate.
15 days
Pregnancy rate
Time Frame: 15 days
We will reffer a correlation between the prostaglandin results and the implantation rate.
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Igenomix

Investigators

  • Principal Investigator: Carlos Simon, MD PhD, Fundacion IVI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

July 10, 2014

First Submitted That Met QC Criteria

July 11, 2014

First Posted (Estimate)

July 14, 2014

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 6, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1311-FIVI-135-CS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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