Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Infertility

Intervention / Treatment
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* Other: Day 3 embryo transfer
* Other: Day 5 embryo transfer


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Day 3 embryo-Own-above cutoff<br>Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates | Other: Day 3 embryo transfer<br>* Extraction of endometrial fluid, analysis of prostaglandine and Day 3 embryo transfer<br>|
| Experimental: Day 5 embryo-Own-above cutoff<br>Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates | Other: Day 5 embryo transfer<br>* Extraction of endometrial fluid, analysis of prostaglandine and Day 5 embryo transfer<br>|
| Experimental: Day 3 embryo-Donor-above cutoff<br>Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates | Other: Day 3 embryo transfer<br>* Extraction of endometrial fluid, analysis of prostaglandine and Day 3 embryo transfer<br>|
| Experimental: Day 5 embryo-Donor- above cutoff<br>Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates | Other: Day 5 embryo transfer<br>* Extraction of endometrial fluid, analysis of prostaglandine and Day 5 embryo transfer<br>|
| Experimental: Day 3 embryo-Donor-lower cutoff<br>Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates | Other: Day 3 embryo transfer<br>* Extraction of endometrial fluid, analysis of prostaglandine and Day 3 embryo transfer<br>|
| Experimental: Day 5 embryo-Donor-lower cutoff<br>Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates | Other: Day 5 embryo transfer<br>* Extraction of endometrial fluid, analysis of prostaglandine and Day 5 embryo transfer<br>|
| Experimental: Day 3 embryo-own-lower cutoff<br>Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates | Other: Day 3 embryo transfer<br>* Extraction of endometrial fluid, analysis of prostaglandine and Day 3 embryo transfer<br>|
| Experimental: Day 5 embryo-own-lower cutoff<br>Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates | Other: Day 5 embryo transfer<br>* Extraction of endometrial fluid, analysis of prostaglandine and Day 5 embryo transfer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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