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CompletedNCT03456375Updated Apr 3, 2019

Serum and Uterine Progesterone Levels and ERA Test.

An observational study in Endometrial Receptivity, sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA. Completed at 1 site in Spain. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2019-04-03.

Sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
75
Ages
18 Years to 50 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Endometrial Receptivity

Keywords

  • progesterone
  • artificial endometrial preparation cycle
  • endometrial receptivity
03

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • Uterine alterations (fibroids, polyps or Müllerian abnormalities)
  • Adnexal pathology
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
75 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

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.

    Time frame: 7 months

Secondary outcomes

  1. Relationship between progesterone levels in uterus and in plasma

    To evaluate correlation between progesterone uterine levels and progesterone plasma levels

    Time frame: 8 months

Other outcomes

  1. Relationship between progesterone uterine levels and Endometrial receptivity

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

    Time frame: 8 months

06

Study locations

1 site
  • IVI RMA Valencia
    Valencia, 46117, Spain
07

References and documents

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. PubMed 34382075 ↗
08

Registry details

Key details

Study ID
NCT03456375
Lead sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Responsible party
Sponsor
First posted
Mar 7, 2018
Start date
Mar 13, 2018
Primary completion
Mar 15, 2019
Completion
Mar 15, 2019
Last update
Apr 3, 2019

Study contacts

Elena Labarta, MD
principal investigator · IVI Vakencia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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