Serum and Uterine Progesterone Levels and ERA Test.
Correlation Between Serum Progesterone Levels and the Endometrial Gene Expression Profile of 238 Genes Related With Endometrial Receptivity (Through Patented ERA Test), as Well as Correlation With Endometrial Progesterone Levels.
1 other identifier
observational
75
1 country
1
Brief Summary
Since the implantation is related with endometrial receptivity, the patient specific plasma progesterone concentration influences this pattern. Following this hypothesis, the study establishes a correlation between the serum progesterone measured on the day of the endometrial biopsy and the endometrial receptivity with the ERA test.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2018
CompletedFirst Posted
Study publicly available on registry
March 7, 2018
CompletedStudy Start
First participant enrolled
March 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2019
CompletedApril 3, 2019
April 1, 2019
1 year
February 22, 2018
April 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progesterone plasma levels and Endometrial receptivity analysis result
To evaluate correlation between progesterone plasma levels and endometrial receptivity through ERA test in infertile women.
7 months
Secondary Outcomes (1)
Relationship between progesterone levels in uterus and in plasma
8 months
Other Outcomes (1)
Relationship between progesterone uterine levels and Endometrial receptivity
8 months
Eligibility Criteria
Infertile patients with background of failed IVF cycles in which an endometrial receptivity test (ERA test) is performed in the context of an artificial cycle.
You may qualify if:
- Infertile women \<50 years
- One or more failed IVF treatments
- Undergoing an artificial endometrial preparation cycle with hormonal replacement therapy in order to perform an endometrial receptivity analysis through ERA test.
- Endometrial thickness after estrogen treatment \> 6.5 mm with trilaminar structure
You may not qualify if:
- Uterine alterations (fibroids, polyps or Müllerian abnormalities)
- Adnexal pathology
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IVI RMA Valencia
Valencia, 46117, Spain
Related Publications (1)
Labarta E, Sebastian-Leon P, Devesa-Peiro A, Celada P, Vidal C, Giles J, Rodriguez-Varela C, Bosch E, Diaz-Gimeno P. Analysis of serum and endometrial progesterone in determining endometrial receptivity. Hum Reprod. 2021 Oct 18;36(11):2861-2870. doi: 10.1093/humrep/deab184.
PMID: 34382075DERIVED
Biospecimen
Endometrial biopsies, Blood sample
Study Officials
- PRINCIPAL INVESTIGATOR
Elena Labarta, MD
IVI Vakencia
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2018
First Posted
March 7, 2018
Study Start
March 13, 2018
Primary Completion
March 15, 2019
Study Completion
March 15, 2019
Last Updated
April 3, 2019
Record last verified: 2019-04