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Microbiome and Endometrial Receptivity in Obese Infertile Women

Microbiome and Endometrial Receptivity in Obese Infertile Women

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03493529
Enrollment
80
Registered
2018-04-10
Start date
2018-05-31
Completion date
2022-12-31
Last updated
2023-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Receptivity

Keywords

Endometrial microbiome, Obesity, Bacterial pathogens, Dysbiosis, Endometrial receptivity

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

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)

Interventions

None listed

Sponsors

IVI Bilbao
CollaboratorOTHER
IVI Barcelona
CollaboratorOTHER
Igenomix
CollaboratorINDUSTRY
Instituto Valenciano de Infertilidad, IVI VALENCIA
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Microbiological analysis of endometrial fluid samples through massive sequencing14 monthsIdentification 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

MeasureTime frameDescription
Microbiological analysis of saliva samples through massive sequencing.14 monthsIdentification 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.
Microbiological analysis of feces samples through massive sequencing.14 monthsIdentification 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.
Analysis of endometrial receptivity using niERA13 monthsAnalysis of the optimal implantation window through the study of the expression of 238 genes involved in receptivity using endometrial fluid samples.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026