Serum and Uterine Progesterone Levels and ERA Test.

Endometrial Receptivity Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03456375
• Other study ID #: 1706-VLC-051-EL
• Status: Completed
• Start date: March 13, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: April 2019
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Receptivity

Locations

Country	Name	City	State
Spain	IVI RMA Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Relationship between progesterone uterine levels and Endometrial receptivity	To evaluate correlation between progesterone uterine levels and endometrial receptivity through ERA test.	8 months
Primary	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	Relationship between progesterone levels in uterus and in plasma	To evaluate correlation between progesterone uterine levels and progesterone plasma levels	8 months