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Incidence of Non Receptive Endometrium in Obese Women

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Endometrial Receptivity Array analysis of endometrial biopsy
Sponsored by
Instituto Valenciano de Infertilidad, IVI VALENCIA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Stamford University
  • Baylor College of Medicine
  • IVI Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A

Group B

Arm Description

Non Obese patients

Obese patients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Distribution of fat and risk factors
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.
Look for specific endometrial gene patterns.
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.
Evaluate the result of assisted reproduction treatment.
Relate if the displacement of the WOI induced by the obesity is clinically relevant after the personalized embryo transfer.

Full Information

First Posted
July 25, 2014
Last Updated
June 26, 2019
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
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1. Study Identification

Unique Protocol Identification Number
NCT02205866
Brief Title
Incidence of Non Receptive Endometrium in Obese Women
Official Title
Incidence of Not Receptive Endometrium During the Window of Implantation as Body Mass Index by Testing ERA.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Non Obese patients
Arm Title
Group B
Arm Type
Experimental
Arm Description
Obese patients
Intervention Type
Other
Intervention Name(s)
Endometrial Receptivity Array analysis of endometrial biopsy
Intervention Description
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 Outcome Measure Information:
Title
Non Receptive Endometrium
Description
To evaluate the incidence of Not Receptive endometrium in obese infertile women compared to infertile normal weight women using an adequate sample size.
Time Frame
25 days
Secondary Outcome Measure Information:
Title
Distribution of fat and risk factors
Description
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.
Time Frame
4 months
Title
Look for specific endometrial gene patterns.
Description
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.
Time Frame
25 days
Title
Evaluate the result of assisted reproduction treatment.
Description
Relate if the displacement of the WOI induced by the obesity is clinically relevant after the personalized embryo transfer.
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Bellver, MD PhD
Organizational Affiliation
IVI Valencia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stamford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305-5101
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
IVI Valencia
City
Valencia
ZIP/Postal Code
46015
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27919438
Citation
Comstock IA, Diaz-Gimeno P, Cabanillas S, Bellver J, Sebastian-Leon P, Shah M, Schutt A, Valdes CT, Ruiz-Alonso M, Valbuena D, Simon C, Lathi RB. Does an increased body mass index affect endometrial gene expression patterns in infertile patients? A functional genomics analysis. Fertil Steril. 2017 Mar;107(3):740-748.e2. doi: 10.1016/j.fertnstert.2016.11.009. Epub 2016 Dec 2.
Results Reference
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Incidence of Non Receptive Endometrium in Obese Women

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