Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer

Infertility Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02189369
• Other study ID #: 1311-FIVI-135-CS
• Status: Recruiting
• Phase: N/A
• First received: July 10, 2014
• Last updated: March 6, 2017
• Start date: February 2015
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: Igenomix
• Contact: Carlos Gómez, MA
• Phone: +34670506469
• Email: carlos.gomez[@]igenomix.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Infertility

Intervention

Other:
• Day 3 embryo transfer
Extraction of endometrial fluid, analysis of prostaglandine and Day 3 embryo transfer
• Day 5 embryo transfer
Extraction of endometrial fluid, analysis of prostaglandine and Day 5 embryo transfer

Locations

Country	Name	City	State
Spain	Fundación IVI	Valencia
Spain	IVI Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Igenomix

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Implantation rate	We will reffer a correlation between the prostaglandin results and the implantation rate.	15 days
Secondary	Pregnancy rate	We will reffer a correlation between the prostaglandin results and the implantation rate.	15 days