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Completed

NCT Number: NCT03493529

Microbiome and Endometrial Receptivity in Obese Infertile Women

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

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Key information

Conditions

ENDOMETRIAL RECEPTIVITY Body Weight Dysbiosis Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–44 year

Sex eligibility

Female

Study type

Observational

Primary location

Ivi Valencia

Valencia, 46015, Spain

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Collaborators

  • IVI Barcelona
  • IVI Bilbao
  • Igenomix

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Apr 10, 2018
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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