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Completed

NCT Number: NCT02205866

Incidence of Non Receptive Endometrium in Obese Women

This study evaluates the incidence of Non Receptive endometrium in obese infertile women compared to infertile normal weight women using Endometrial Receptivity Array (ERA) test, containing 238 genes, identifying the receptivity status of an endometrial sample and diagnosing the patient's Window of Implantation, regardless of the histological appearance of the sample. An endometrial biopsy is collected from the uterine fundus, either in a natural cycle or in a hormonal replacement therapy (HRT) cycle and the test is performed.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IVI Valencia, Valencia, Spain

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infertile women: > 1 year of regular unprotected intercourse without evidence of pregnancy.
  • Normal uterus by 2D/3D ultrasound scan and/or hysteroscopy
  • No endometriosis
  • Presence of both ovaries
  • < 45 years old (in ovum donation, outcome parameters are not affected until this age in all the current published studies).

Exclusion criteria

  • Hydrosalpinx
  • Stage 3-4 endometriosis diagnosed with ultrasound, laparoscopy/ laparotomy.
  • Implantation failure (≥ 4 pre-embryos of good quality transferred without pregnancy)
  • Recurrent pregnancy loss (≥ 2 pregnancies biochemical / clinical)

Treatment and study plan

Endometrial Receptivity Array analysis of endometrial biopsy

Other

A biopsy of endometrium is peformed and Endometrial Receptivity Array analysis is carried out, as well as analysis of fat distribution and risk factors of Metabolic Syndrome.

Primary outcomes

  1. Non Receptive Endometrium

    Time frame: 25 days

    To evaluate the incidence of Not Receptive endometrium in obese infertile women compared to infertile normal weight women using an adequate sample size.

Secondary outcomes

  1. Distribution of fat and risk factors

    Time frame: 4 months

    Carry out a subanalysis concerning the distribution of central and peripheric fat and risk factors of metabolic syndrome including: Age (years); Height (m); Weight (kg) ; BMI (kg/m2); Waist (cm) ; Hip (cm); Index waist-hip ratio (WHR) waist (cm) / hip (cm); Blood pressure; insulinemia Fasting blood glucose (mmol / L); PTG ( tolerance oral glucose ) (mmol / L), Total cholesterol and fractions; Triglycerides Microalbuminuria; bA1C, HC-reactive protein.

  2. Look for specific endometrial gene patterns.

    Time frame: 25 days

    Find patterns of expression of specific genes in endometrial obese women: we will by analyzing the expression of 238 genes obtained after endometrial endometrial biopsy.

  3. Evaluate the result of assisted reproduction treatment.

    Time frame: 12 months

    Relate if the displacement of the WOI induced by the obesity is clinically relevant after the personalized embryo transfer.

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Official study title

Incidence of Not Receptive Endometrium During the Window of Implantation as Body Mass Index by Testing ERA.

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 31, 2014
Registry last updated
Jun 28, 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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