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Clinical Outcomes in a Receptive Endometrium for Infertility

N/A
Recruiting
Led By Maria Ruiz, MSc
Research Sponsored by Igenomix
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-2 months
Awards & highlights

Study Summary

Women´s period comprises different hormonal stages, being one of them the stage for maximum receptivity and proper embryo implantation. This stage is named window of implantation (WOI), and is characterized by a specific molecular pattern than can be assessed by the Endometrial Receptivity Analysis (ERA® test), developed by Igenomix. Determining the WOI allows to schedule a personalized embryo transfer (pET) when the endometrium is most receptive for the implantation. The main objective of the present study is to improve our knowledge on the endometrial factor in an infertile population with previous implantation failures. To do so, a diagnosis of the endometrial receptivity to determine the WOI (ERA®) and the microbiome (EMMA®) of each participant will be performed, assessing its impact on deferred embryo transfers in terms of reproductive outcomes. Participants will follow their previously programmed IVF/ICSI treatment and, only when one embryo with no major anomalies is reported by PGT-A (Preimplantation Genetic Testing for Aneuploidies), they will be asked to attend to the specific study visit for endometrial fluid and biopsy samples collection. These samples will be used to determine the patient's WOI (ERA®) and endometrial microbiome (EMMA®). The results of neither of the tests will be disclosed to the patient or the doctor, being only used for the study purpose. After this visit, the patient will follow the pre-established schedule for an embryo transfer and pregnancy assessment.

Eligible Conditions
  • Implantation Failure
  • Infertility

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Refinement of the ERA® computational analysis
Secondary outcome measures
Biochemical pregnancy rate (BPR) in the FET
Biochemical pregnancy rate (BPR) in the pET
Clinical miscarriage rate (CMR) in the FET
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Clinical Outcomes in a Receptive EndometriumExperimental Treatment1 Intervention
Enrolled patients that according to the ERA® report are receptive. The only additional intervention that patients will undergo, apart from those already scheduled for their ART, is the collection of an endometrial biopsy and endometrial fluid. No drugs will be administered as per the study.
Group II: Clinical Outcomes in a Non-receptive EndometriumExperimental Treatment1 Intervention
Enrolled patients that according to the ERA® report have a displaced WOI and are non-receptive. The only additional intervention that patients will undergo, apart from those already scheduled for their ART, is the collection of an endometrial biopsy and endometrial fluid. No drugs will be administered as per the study.

Find a Location

Who is running the clinical trial?

IgenomixLead Sponsor
34 Previous Clinical Trials
13,693 Total Patients Enrolled
11 Trials studying Infertility
7,527 Patients Enrolled for Infertility
Maria Ruiz, MScPrincipal InvestigatorIgenomix

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~492 spots leftby Apr 2026