ClinicalTrials.gg
CompletedNCT03493529Updated Oct 24, 2023

Microbiome and Endometrial Receptivity in Obese Infertile Women

An observational study in Endometrial Receptivity, sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA. Completed at 1 site in Spain. Open to female participants aged 18 Years to 44 Years. Per ClinicalTrials.gov, last updated 2023-10-24.

Sponsored by Instituto Valenciano de Infertilidad, IVI VALENCIA · Observational

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Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 44 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 387 studies in Obesity with a site in Spain — 92 open to participants now, 131 under way, 43 of them phase 3. Obesity · Spain.

Enrollment
39th of 57
80 · median 128
Started
2018
with 25 others
Observational
57 of 387
19 open now
Registered
108th of 387
by date

Among the 387 studies in Obesity with a site in Spain, this one is the 39th largest by enrollment of the 57 observational ones that give a count, is one of 26 that started in 2018, is one of 57 observational ones, and was the 108th registered.

Obesity

11,536 studies on the registry are indexed under Obesity; 2,042 are open to participants now.

Browse Obesity studies →

Open to participants now

92 of the 387 studies in Obesity with a site in Spain are open now. Recruiting first, the newest first:

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All 92 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 1,339 Obesity studies recruiting now, 377 (28%) set no upper age limit and 859 (64%) stop at 75 or younger; 167 take children under 18; 490 take healthy volunteers.

This study: 18 Years to 44 Years · female · no healthy volunteers.

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02

Study 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

Read the 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)
03

Conditions studied

  • Endometrial Receptivity

Keywords

  • Endometrial microbiome
  • Obesity
  • Bacterial pathogens
  • Dysbiosis
  • Endometrial receptivity
04

Who can participate

Ages eligible
18 Years to 44 Years
Sexes eligible
Female
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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 , , , RPR

Exclusion criteria

Exclusion Criteria:

  • Taking prescribed antibiotics or using IUDs or 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (actual)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

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.

    Time frame: 14 months

Secondary outcomes

  1. Microbiological analysis of saliva samples through massive sequencing.

    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.

    Time frame: 14 months

  2. Microbiological analysis of feces samples through massive sequencing.

    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.

    Time frame: 14 months

  3. Analysis of endometrial receptivity using niERA

    Analysis of the optimal implantation window through the study of the expression of 238 genes involved in receptivity using endometrial fluid samples.

    Time frame: 13 months

07

Study locations

1 site
  • Ivi Valencia
    Valencia, 46015, Spain
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2018 to primary completion in Sep 2021, 39 months.

Of 793 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's 39 months is close to that.

Counting every sponsor, half of 838 studies reached it within 39 months; a quarter within 17 and three quarters within 96.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 8, 2018
First posted
Apr 10, 2018
StartActual
May 31, 2018
Primary completionActual
Sep 16, 2021
CompletionActual
Dec 31, 2022
Last update
Oct 24, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03493529
Lead sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Collaborators
IVI Bilbao, IVI Barcelona, Igenomix
Responsible party
Sponsor
First posted
Apr 10, 2018
Start date
May 31, 2018
Primary completion
Sep 16, 2021
Completion
Dec 31, 2022
Last update
Oct 24, 2023

Study contacts

JOSE BELLVER PRADAS, MD
principal investigator · IVIRMA VALENCIA

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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