CClinicalTrials.gg
Status unknownNCT02189369Updated Mar 7, 2017

Diagnostic Test for Endometrial Receptivity 24 Hours Before Embryo Transfer

An interventional study of Day 3 embryo transfer and Day 5 embryo transfer in Infertility, sponsored by Igenomix. Status unknown at 2 sites in Spain. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2017-03-07.

Sponsored by Igenomix · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Non-randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Infertility

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03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's planned enrollment of 120 is close to the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Igenomix is the lead sponsor of 29 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with recurrent miscarriages ( ≥ 2 biochemical miscarriages; ≥ 2 clinical miscarriage)
  • Patients with severe male factor ( ≥ 2*106 espermatozoides/ml).
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Day 3 embryo-Own-above cutoff

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

    Other: Day 3 embryo transfer

  • Experimental
    Day 5 embryo-Own-above cutoff

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

    Other: Day 5 embryo transfer

  • Experimental
    Day 3 embryo-Donor-above cutoff

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

    Other: Day 3 embryo transfer

  • Experimental
    Day 5 embryo-Donor- above cutoff

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

    Other: Day 5 embryo transfer

  • Experimental
    Day 3 embryo-Donor-lower cutoff

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

    Other: Day 3 embryo transfer

  • Experimental
    Day 5 embryo-Donor-lower cutoff

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

    Other: Day 5 embryo transfer

  • Experimental
    Day 3 embryo-own-lower cutoff

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

    Other: Day 3 embryo transfer

  • Experimental
    Day 5 embryo-own-lower cutoff

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

    Other: Day 5 embryo transfer

Interventions

  • OtherDay 3 embryo transfer

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

  • OtherDay 5 embryo transfer

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

06

What researchers measure

Primary outcomes

  1. endometrial receptivity

    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 outcomes

  1. Implantation rate

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

    Time frame: 15 days

  2. Pregnancy rate

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

    Time frame: 15 days

07

Study locations

2 of 2 sites recruiting
  • Fundación IVI
    Valencia, 46015, Spain
    • Carlos Gómez, Ma · Contact · carlos.gomez@igenomix.com · +34670506469
    • Carlos Simón, MD, PhD · Principal investigator
    • Felip Vilella, PhD · Sub investigator
    Recruiting
  • IVI Valencia
    Valencia, 46015, Spain
    • Carlos Gómez, MA · Contact · carlos.gomez@igenomix.com
    • Carlos Simón, MD, PhD · Principal investigator
    • Marcos Meseguer, PhD · Sub investigator
    • Sergio Cabanillas, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02189369
Lead sponsor
Igenomix
Responsible party
Carlos Simon (Dr. Carlos Simón, Igenomix) — Principal investigator
First posted
Jul 14, 2014
Start date
Feb 2015
Primary completion
Sep 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Mar 7, 2017

Study contacts

Carlos Gómez, MA
Contact
carlos.gomez@igenomix.com
+34670506469
Carlos Simon, MD PhD
principal investigator · Fundación IVI

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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