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ERA Test in Patients With Recurrent Implantation Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Igenomix
Sponsor:
Information provided by (Responsible Party):
Carlos Simon, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01668693
First received: August 13, 2012
Last updated: July 10, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to demonstrate the clinical efficiency of the Endometrial Receptivity Array (ERA) diagnostic tool in patients with repetitive implantation failure (RIF), leading to the new concept of the personalized window of implantation (pWOI) as diagnostic and treatment of patients with RIF of endometrial origin.


Condition Intervention
Repetitive Implantation Failure
Other: ERA (Endometrial Receptivity Array)
Other: Personalized Embryo Transfer
Other: Second ERA

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Endometrial Receptivity Array (ERA) as Diagnosis and Personalized Embryo Transfer (pET) as Treatment in Patients With Receptive Implantation Failure (RIF).

Resource links provided by NLM:


Further study details as provided by Igenomix:

Primary Outcome Measures:
  • Detection of the Receptive or Non Receptive endometrial status according to the ERA test. [ Time Frame: 1 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Implantation [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RIF ERA Receptive 1
With the "receptive" results from the first Endometrial Receptivity Array (ERA), the patients will undergo embryo transfer on Day 5 of Progesterone administration in the cycle following the ERA diagnosis.
Other: ERA (Endometrial Receptivity Array)
The diagnostic tool ERA will be performed on all of the patients in order to allocate them in the group "Receptive" or "Non Receptive" and to predict the number of days of Progesterone administration necesary to obtain the "Receptive" prediction.
Other: Personalized Embryo Transfer
When the ERA indicates receptivity, the patient will undergo the embryo transfer on the day indicated by the diagnostic tool.
Experimental: RIF ERA Non Receptive
The "Non Receptive" results of the ERA diagnotic tool will indicate how many more days of Progesterone are necesary in order to obtain the "Receptive" daignosis. A second ERA will take place to confirm receptivity and in the following cycle, the personalized embryo transfer will take place on the day predicted by this diagnostic tool.
Other: ERA (Endometrial Receptivity Array)
The diagnostic tool ERA will be performed on all of the patients in order to allocate them in the group "Receptive" or "Non Receptive" and to predict the number of days of Progesterone administration necesary to obtain the "Receptive" prediction.
Other: Personalized Embryo Transfer
When the ERA indicates receptivity, the patient will undergo the embryo transfer on the day indicated by the diagnostic tool.
Other: Second ERA
A second ERA will be performed to confirm receptivity after further administration of Progesterone.

Detailed Description:

Intervention(s): Endometrial sampling, either at LH+7 in a natural cycle or after 5 days of progesterone in a hormonal replacement cycle (HRT) and personalized embryo transfer (pET) on the designated day guided by the ERA prediction.

Repeated implantation failure (RIF) is an unsolved not well characterized major cause of infertility in otherwise healthy women. Although various definitions of RIF exist, the clinical community agrees that after failure of three IVF cycles, in which one to two morphologically high-grade embryos have been transferred, special protocols must be enforced, although no hard data from RCTs demonstrates that any of the current approaches in RIF have a significant clinical value .

Based on the large amount of information generated about the regulation and deregulation of the genes implicated in the endometrial window of receptivity (WOR), our group has developed a molecular diagnostic tool based on the specific transcriptomic signature that identifies the receptive endometrium at LH+7 in a natural cycle or on day 5 of progesterone impregnation (P+5) after proper estradiol priming in a hormonal replacement therapy (HRT) cycle. The endometrial receptivity array (ERA) consists of a customized array containing 238 genes differentially expressed that is coupled to a computational predictor able to diagnose the personalized endometrial WOI of a given patient, regardless of its histological appearance. The accuracy of the diagnostic tool ERA has been demonstrated to be superior to endometrial histology and results are completely reproducible 29 to 40 months later.

Compelling evidence indicates the existence of an endometrial receptivity alteration in patients with RIF.

The aim of this study is to demonstrate the diagnostic efficiency of the ERA test in RIF patients by identifying putative alterations related to the displacement of their personalized window of receptivity, and the therapeutic implications through personalization of the day of embryo transfer (pET), following the diagnosis obtained by this molecular diagnostic tool. An endometrial biopsy on day LH+7 in a natural cycle or on day P+5 in an HRT cycle and ERA diagnosis of receptive or non-receptive is informed. In receptive cases, embryo transfer (ET) will be performed in subsequent cycles on the indicated day. In non-receptive ERA, the test is to be repeated on the dayindicated by the predictor, and personalized ET guided in subsequent cycles according to ERA diagnosis.

  Eligibility

Ages Eligible for Study:   20 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women ≤38 years old
  • Normal ovarian reserve
  • FSH <8mIU/mL
  • Cycle with ≥6 MII oocytes/oocyte retrieval
  • ≥3 implantation failures in previous IVF/ICSI cycles with transfer of atleast two good quality embryos in each cycle Inclusion Criteria for ovum donation recipients
  • ≥3 implantation failures with transfer of atleast two good quality embryos in each cycle
  • Endometrial thickness ≥ 6 mm
  • Trilaminar pattern after proper progesterone priming

Exclusion Criteria:

  • Existance of hydrosalpinx
  • Atrophic endometrium < 6 mm
  • Previous ectopic or uterine miscarriages
  • Presence of myomas or polyps
  • Previous embryo transfer with high difficulty and/or bleeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01668693

Contacts
Contact: Carlos Simón, MD PhD 34963050900 carlos.simon@ivi.es
Contact: Cristina Caruana, MA 34670506469 cristina.caruana@iviomics.com

Locations
Spain
IVI Recruiting
Valencia, VAencia, Spain
Contact: Carlos Simon         
Sponsors and Collaborators
Igenomix
Investigators
Principal Investigator: Carlos Simón, MD PhD IVIOMICS / IVI Valencia
  More Information

No publications provided

Responsible Party: Carlos Simon, MD PhD, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier: NCT01668693     History of Changes
Other Study ID Numbers: 0600-E-905-JH
Study First Received: August 13, 2012
Last Updated: July 10, 2014
Health Authority: Spain: Ministry of Health

Keywords provided by Igenomix:
Endometrial receptivity
recurrent implantation failure
predictor tool
ERA
customized microarray
personalized embryo transfer

Additional relevant MeSH terms:
Progesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Progestins

ClinicalTrials.gov processed this record on November 20, 2014