Microbiome and Endometrial Receptivity in Obese Infertile Women

October 23, 2023 updated by: Instituto Valenciano de Infertilidad, IVI VALENCIA
The objective of this project is the identification and quantification of the main bacterial communities present in the endometrial microbiota in obese infertile patients, to assess if there is an alteration of their composition dependent on the body mass index, and if such alteration it could influence the reduction of endometrial receptivity, demonstrated in obese women. If obese patients have an altered digestive microbiota and, at the same time, a lower endometrial receptivity, the investigator want to assess whether such reduction in receptivity may depend on an alteration in the endometrial microbiota, which in non-obese infertile patients has been shown to negatively influence the reproductive results

Study Overview

Status

Completed

Conditions

Detailed Description

The main objective of our study is to compare the composition of the endometrial microbiota between patients with normal weight and patients with obesity.

A. Secondary Objectives/research questions

  • To analyze the composition of the digestive microbiota through samples of saliva and feces in infertile patients with normal weight and obesity.
  • To assess whether there is a relationship between the body mass index (normal weight, obesity Class I, Class II, Class III) and the main bacterial species detected in endometrial fluid samples from infertile patients.
  • To evaluate the influence of the digestive microbiota on the composition of the endometrial microbiota according to the body mass index in infertile patients.
  • To evaluate if there is an influence of the endometrial microbiota on the results of endometrial receptivity analyzed with the non-invasive Endometrial Receptivity Array test (niERA)

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Valencia, Spain, 46015
        • IVI Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Infertile patients with normal weight (BMI: between 18.50 and 29.99) and obesity (Class I: BMI between 30 and 34.99 Kg / m2, Class II: BMI between 35 and 39.99 Kg / m2, Class III: BMI> 40 Kg / m2) subjected to Hormonal Replacement Therapy (HRT).

Description

Inclusion Criteria:

  • Infertile patients undergoing artificial cycle with HRT.
  • Normal uterus confirmed by ultrasound (absence of uterine pathology such as submucosal or intramural myomas> 4 cm that deform cavity, endometrial polyps or Müllerian anomalies, or adnexal as communicating hydrosalpinx).
  • Negative serological tests for HIV, HBV, HCV, RPR

Exclusion Criteria:

  • Taking prescribed antibiotics or using IUDs or contraceptives 3 months prior to taking the sample. NOTE: Patients who have taken prophylactic antibiotics for ovarian puncture may be included at least 1 month before taking the sample.
  • Age> 45 years
  • Uncorrected uterine pathology, uncorrected hydrosalpinx
  • Recurrent miscarriage (≥2 spontaneous abortions) or failure of implantation (transfer of 6 embryos in day 3 or 4 blastocysts in a cycle of IVF or donation of oocytes without gestation)
  • Existence of serious or uncontrolled bacterial, fungal or viral infections that, in the opinion of the principal investigator, could interfere with the participation of the patient in the study or in the evaluation of the results of the study.
  • Any disease or medical condition that is unstable or could endanger the patient's safety and compliance in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Normal Weight
BMI: Between 18.50 and 29.99 kg/m2
Obesity Clas I
BMI between 30 and 34.99 Kg/m2
Obesity Clas II
BMI between 35 and 39.99 Kg/m2
Obesity Clas III
BMI> 40 Kg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiological analysis of endometrial fluid samples through massive sequencing
Time Frame: 14 months
Identification and quantification of the main bacterial communities present in the endometrial microbiota of obese and normal-weight infertile patients through the analysis of the endometrial fluid.
14 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Microbiological analysis of saliva samples through massive sequencing.
Time Frame: 14 months
Identification and quantification of the main bacterial communities present in the oral microbiota of obese and normal-weight infertile patients through the analysis of saliva samples.
14 months
Microbiological analysis of feces samples through massive sequencing.
Time Frame: 14 months
Identification and quantification of the main bacterial communities present in the intestinal microbiota of obese and normal-weight infertile patients through the analysis of feces samples.
14 months
Analysis of endometrial receptivity using niERA
Time Frame: 13 months
Analysis of the optimal implantation window through the study of the expression of 238 genes involved in receptivity using endometrial fluid samples.
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Collaborators

IVI Barcelona
IVI Bilbao
Igenomix

Investigators

  • Principal Investigator: JOSE BELLVER PRADAS, MD, Ivirma Valencia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2018

Primary Completion (Actual)

September 16, 2021

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

March 8, 2018

First Submitted That Met QC Criteria

April 3, 2018

First Posted (Actual)

April 10, 2018

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1711-VLC-108-JB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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