Incidence of Non Receptive Endometrium in Obese Women

NCT ID: NCT02205866

Last Updated: 2019-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

Non Obese patients

Group Type ACTIVE_COMPARATOR

Endometrial Receptivity Array analysis of endometrial biopsy

Intervention Type 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 B

Obese patients

Group Type EXPERIMENTAL

Endometrial Receptivity Array analysis of endometrial biopsy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Endometrial Receptivity Array analysis of endometrial biopsy

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jose Bellver

Dr. Jose Bellver

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jose Bellver, MD PhD

Role: PRINCIPAL_INVESTIGATOR

IVI Valencia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stamford University

Palo Alto, California, United States

Site Status

Baylor College of Medicine

Houston, Texas, United States

Site Status

IVI Valencia

Valencia, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 27919438 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1403-VLC-012-JB

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.