Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer
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
1 other identifier
interventional
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2015
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2014
CompletedFirst Posted
Study publicly available on registry
July 14, 2014
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 7, 2017
March 1, 2017
2.6 years
July 10, 2014
March 6, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
endometrial receptivity
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 Outcomes (2)
Implantation rate
15 days
Pregnancy rate
15 days
Study Arms (8)
Day 3 embryo-Own-above cutoff
EXPERIMENTALDay 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates
Day 5 embryo-Own-above cutoff
EXPERIMENTALDay 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates
Day 3 embryo-Donor-above cutoff
EXPERIMENTALDay 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates
Day 5 embryo-Donor- above cutoff
EXPERIMENTALDay 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates
Day 3 embryo-Donor-lower cutoff
EXPERIMENTALDay 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates
Day 5 embryo-Donor-lower cutoff
EXPERIMENTALDay 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates
Day 3 embryo-own-lower cutoff
EXPERIMENTALDay 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates
Day 5 embryo-own-lower cutoff
EXPERIMENTALDay 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates
Interventions
Extraction of endometrial fluid, analysis of prostaglandine and Day 3 embryo transfer
Extraction of endometrial fluid, analysis of prostaglandine and Day 5 embryo transfer
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with recurrent miscarriages ( ≥ 2 biochemical miscarriages; ≥ 2 clinical miscarriage)
- Patients with severe male factor ( ≥ 2\*106 espermatozoides/ml).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Igenomixlead
Study Sites (2)
Fundación IVI
Valencia, Valencia, 46015, Spain
IVI Valencia
Valencia, Valencia, 46015, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Simon, MD PhD
Fundación IVI
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Carlos Simón
Study Record Dates
First Submitted
July 10, 2014
First Posted
July 14, 2014
Study Start
February 1, 2015
Primary Completion
September 1, 2017
Study Completion
December 1, 2017
Last Updated
March 7, 2017
Record last verified: 2017-03