Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer

NCT ID: NCT02189369

Last Updated: 2017-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-12-31

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.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Day 3 embryo-Own-above cutoff

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

Group Type EXPERIMENTAL

Day 3 embryo transfer

Intervention Type OTHER

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

Day 5 embryo-Own-above cutoff

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

Group Type EXPERIMENTAL

Day 5 embryo transfer

Intervention Type OTHER

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

Day 3 embryo-Donor-above cutoff

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

Group Type EXPERIMENTAL

Day 3 embryo transfer

Intervention Type OTHER

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

Day 5 embryo-Donor- above cutoff

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

Group Type EXPERIMENTAL

Day 5 embryo transfer

Intervention Type OTHER

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

Day 3 embryo-Donor-lower cutoff

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

Group Type EXPERIMENTAL

Day 3 embryo transfer

Intervention Type OTHER

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

Day 5 embryo-Donor-lower cutoff

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

Group Type EXPERIMENTAL

Day 5 embryo transfer

Intervention Type OTHER

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

Day 3 embryo-own-lower cutoff

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

Group Type EXPERIMENTAL

Day 3 embryo transfer

Intervention Type OTHER

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

Day 5 embryo-own-lower cutoff

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

Group Type EXPERIMENTAL

Day 5 embryo transfer

Intervention Type OTHER

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

Interventions

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Day 3 embryo transfer

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

Intervention Type OTHER

Day 5 embryo transfer

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

Intervention Type OTHER

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Igenomix

INDUSTRY

Sponsor Role lead

Responsible Party

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Carlos Simon

Dr. Carlos Simón

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos Simon, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Fundación IVI

Locations

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Fundación IVI

Valencia, Valencia, Spain

Site Status RECRUITING

IVI Valencia

Valencia, Valencia, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Carlos Gómez, MA

Role: CONTACT

+34670506469

Facility Contacts

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Carlos Gómez, Ma

Role: primary

+34670506469

Carlos Gómez, MA

Role: primary

Other Identifiers

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1311-FIVI-135-CS

Identifier Type: -

Identifier Source: org_study_id

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