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Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer

Primary Purpose

Infertility

Status

Unknown status

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Day 3 embryo transfer

Day 5 embryo transfer

About this trial

This is an interventional basic science trial for Infertility

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

Fundación IVIRecruiting
IVI ValenciaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Arm Label

Day 3 embryo-Own-above cutoff

Day 5 embryo-Own-above cutoff

Day 3 embryo-Donor-above cutoff

Day 5 embryo-Donor- above cutoff

Day 3 embryo-Donor-lower cutoff

Day 5 embryo-Donor-lower cutoff

Day 3 embryo-own-lower cutoff

Day 5 embryo-own-lower cutoff

Arm Description

Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates

Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates

Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates

Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates

Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates

Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates

Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates

Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates

Outcomes

Primary Outcome Measures

endometrial receptivity

The endometrial samples will be extracted 24 hours before the embryo transfer in order to analyze the quantity of prostaglandins.

Secondary Outcome Measures

Implantation rate

We will reffer a correlation between the prostaglandin results and the implantation rate.

Pregnancy rate

We will reffer a correlation between the prostaglandin results and the implantation rate.

Full Information

NCT ID

NCT02189369

First Posted

July 10, 2014

Last Updated

March 6, 2017

Sponsor

Igenomix

1. Study Identification

Unique Protocol Identification Number

NCT02189369

Brief Title

Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 2015 (undefined)

Primary Completion Date

September 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Igenomix

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Day 3 embryo-Own-above cutoff

Arm Type

Experimental

Arm Description

Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates

Arm Title

Day 5 embryo-Own-above cutoff

Arm Type

Experimental

Arm Description

Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with higher receptivty rates

Arm Title

Day 3 embryo-Donor-above cutoff

Arm Type

Experimental

Arm Description

Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates

Arm Title

Day 5 embryo-Donor- above cutoff

Arm Type

Experimental

Arm Description

Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with higher receptivty rates

Arm Title

Day 3 embryo-Donor-lower cutoff

Arm Type

Experimental

Arm Description

Day 3 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates

Arm Title

Day 5 embryo-Donor-lower cutoff

Arm Type

Experimental

Arm Description

Day 5 embryo transfer for IVF with donor oocytes, and prostaglandine levels with lower receptivty rates

Arm Title

Day 3 embryo-own-lower cutoff

Arm Type

Experimental

Arm Description

Day 3 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates

Arm Title

Day 5 embryo-own-lower cutoff

Arm Type

Experimental

Arm Description

Day 5 embryo transfer for IVF with own oocytes, and prostaglandine levels with lower receptivty rates

Intervention Type

Other

Intervention Name(s)

Day 3 embryo transfer

Intervention Description

Extraction of endometrial fluid, analysis of prostaglandine and Day 3 embryo transfer

Intervention Type

Other

Intervention Name(s)

Day 5 embryo transfer

Intervention Description

Extraction of endometrial fluid, analysis of prostaglandine and Day 5 embryo transfer

Primary Outcome Measure Information:

Title

endometrial receptivity

Description

The endometrial samples will be extracted 24 hours before the embryo transfer in order to analyze the quantity of prostaglandins.

Time Frame

24 hours before embryo transfer

Secondary Outcome Measure Information:

Title

Implantation rate

Description

We will reffer a correlation between the prostaglandin results and the implantation rate.

Time Frame

15 days

Title

Pregnancy rate

Description

We will reffer a correlation between the prostaglandin results and the implantation rate.

Time Frame

15 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Carlos Gómez, MA

Phone

+34670506469

carlos.gomez@igenomix.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos Simon, MD PhD

Organizational Affiliation

Fundación IVI

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fundación IVI

City

Valencia

ZIP/Postal Code

46015

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carlos Gómez, Ma

Phone

+34670506469

carlos.gomez@igenomix.com

First Name & Middle Initial & Last Name & Degree

Carlos Simón, MD, PhD

First Name & Middle Initial & Last Name & Degree

Felip Vilella, PhD

Facility Name

IVI Valencia

City

Valencia

ZIP/Postal Code

46015

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carlos Gómez, MA

carlos.gomez@igenomix.com

First Name & Middle Initial & Last Name & Degree

Carlos Simón, MD, PhD

First Name & Middle Initial & Last Name & Degree

Marcos Meseguer, PhD

First Name & Middle Initial & Last Name & Degree

Sergio Cabanillas, MD

12. IPD Sharing Statement

Learn more about this trial

Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer

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