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OpenTrials
Completed

NCT Number: NCT03456375

Serum and Uterine Progesterone Levels and ERA Test.

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.

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Key information

Conditions

ENDOMETRIAL RECEPTIVITY

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

IVI RMA Valencia

Valencia, 46117, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Progesterone plasma levels and Endometrial receptivity analysis result

    Time frame: 7 months

    To evaluate correlation between progesterone plasma levels and endometrial receptivity through ERA test in infertile women.

Secondary outcomes

  1. Relationship between progesterone levels in uterus and in plasma

    Time frame: 8 months

    To evaluate correlation between progesterone uterine levels and progesterone plasma levels

Other outcomes

  1. Relationship between progesterone uterine levels and Endometrial receptivity

    Time frame: 8 months

    To evaluate correlation between progesterone uterine levels and endometrial receptivity through ERA test.

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2018
Registry last updated
Apr 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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