Microbiome and Endometrial Receptivity in Obese Infertile Women

NCT03493529 | Completed

• 1 other identifier: 1711-VLC-108-JB
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometrial Receptivity

Keywords

Endometrial microbiome; Obesity; Bacterial pathogens; Dysbiosis; Endometrial receptivity

Outcome Measures

Primary Outcomes (1)

• Microbiological analysis of endometrial fluid samples through massive sequencing

  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 Outcomes (3)

• Microbiological analysis of saliva samples through massive sequencing.

  14 months

• Microbiological analysis of feces samples through massive sequencing.

  14 months

• Analysis of endometrial receptivity using niERA

  13 months

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Valenciano de Infertilidad, IVI VALENCIA: lead
• IVI Bilbao: collaborator
• IVI Barcelona: collaborator
• Igenomix: collaborator

Study Sites (1)

Ivi Valencia

Valencia, 46015, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples of saliva, feces and endometrial fluid.

MeSH Terms

Conditions

Obesity; Dysbiosis

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• JOSE BELLVER PRADAS, MD

  IVIRMA VALENCIA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2018
• First Posted: April 10, 2018
• Study Start: May 31, 2018
• Primary Completion: September 16, 2021
• Study Completion: December 31, 2022
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)