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.

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.

Study Overview

• Status: Completed
• Conditions: Endometrial Receptivity

Detailed Description

In patients who have had problems of assisted reproduction it is essential to establish the factors that contribute to the success of a cycle: correcting these factors means increasing the possibility of the cycle culminating in pregnancy.

In patients with embryonic implantation failures, a prevalence of non-receptive endometrium has been described after performing the ERA test of around 20%. On the other hand, a study that shows embryonic generation values below a certain threshold (25th percentile), presents a rate of evolutionary clinical gestation and lower embryo implantation.

It is logical to think that progesterone levels are lower than the state of endometrial receptivity, since the hormone is responsible for the endothelial changes that prepare the uterus for implantation. It is ERA. The result of this study is the result of the evaluation of the lifetime of the endometrial biopsy is related to the result of the same.

If desired, the determination of the probability of the day of the transfer is predictive of the pregnancy rate through the impact that the hormone has on the endometrial receptivity. This would allow to decide in the same cycle, if the patient should be in a transfer to another dimension, or should it defer to another cycle where obtain the optimal values of progesterone.

Nowadays, there are no publications in the literature that have related the concentration of progesterone with endometrial receptivity through ERA. This is the first prospective study that analyzes this relationship.

The ERA test has been chosen for the evaluation of endometrial receptivity, which is a tool that has been widely used and used in the usual clinical practice of our clinic.

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain, 46117
    • IVI RMA Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Uterine alterations (fibroids, polyps or Müllerian abnormalities)
• Adnexal pathology

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between progesterone levels in uterus and in plasma	To evaluate correlation between progesterone uterine levels and progesterone plasma levels	8 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between progesterone uterine levels and Endometrial receptivity	To evaluate correlation between progesterone uterine levels and endometrial receptivity through ERA test.	8 months

Collaborators and Investigators

• Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Investigators: Principal Investigator: Elena Labarta, MD, IVI Vakencia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2018
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: February 28, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Actual): April 3, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: progesterone; endometrial receptivity; artificial endometrial preparation cycle
• Other Study ID Numbers: 1706-VLC-051-EL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No