Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer

Not Applicable

• Conditions: Infertility
• Interventions: Other: Day 3 embryo transfer; Other: Day 5 embryo transfer

• Registration Number: NCT02189369
• Lead Sponsor: Igenomix

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-10
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-14
• Study Start: 2015-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-06
• Last Update Posted: 2017-03-07
• Primary Completion: 2017-09
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Day 3 embryo-Own-above cutoff	Day 3 embryo transfer	Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates
Day 5 embryo-Own-above cutoff	Day 5 embryo transfer	Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates
Day 3 embryo-Donor-lower cutoff	Day 3 embryo transfer	Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates
Day 3 embryo-own-lower cutoff	Day 3 embryo transfer	Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates
Day 3 embryo-Donor-above cutoff	Day 3 embryo transfer	Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates
Day 5 embryo-Donor-lower cutoff	Day 5 embryo transfer	Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates
Day 5 embryo-Donor- above cutoff	Day 5 embryo transfer	Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates
Day 5 embryo-own-lower cutoff	Day 5 embryo transfer	Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates

Primary Outcome Measures

Name	Time	Method
endometrial receptivity	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

Name	Time	Method
Implantation rate	15 days	We will reffer a correlation between the prostaglandin results and the implantation rate.
Pregnancy rate	15 days	We will reffer a correlation between the prostaglandin results and the implantation rate.

Trial Locations

Locations (2)

Fundación IVI; 🇪🇸 Valencia, Spain

IVI Valencia; 🇪🇸 Valencia, Spain