Incidence of Non Receptive Endometrium in Obese Women

NCT02205866 | Completed

• 1 other identifier: 1403-VLC-012-JB
• Study Type: interventional
• Target: 183
• Locations: 2 countries
• Sites: 3

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• 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.

  25 days

Secondary Outcomes (3)

• Distribution of fat and risk factors

  4 months

• Look for specific endometrial gene patterns.

  25 days

• Evaluate the result of assisted reproduction treatment.

  12 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

Non Obese patients

Other: Endometrial Receptivity Array analysis of endometrial biopsy

Group B

EXPERIMENTAL

Obese patients

Other: Endometrial Receptivity Array analysis of endometrial biopsy

Interventions

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.

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Instituto Valenciano de Infertilidad, IVI VALENCIA: lead

Study Sites (3)

Stamford University

Palo Alto, California, 94305-5101, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

IVI Valencia

Valencia, 46015, Spain

Location

Related Publications (1)

• 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.

  PMID: 27919438 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Jose Bellver, MD PhD

  IVI Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Jose Bellver

Study Record Dates

• First Submitted: July 25, 2014
• First Posted: July 31, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 31, 2017
• Last Updated: June 28, 2019

Record last verified: 2019-06

Locations

US (2); ES (1)