Endometrial ReceptivityNCT03493529
Microbiome and Endometrial Receptivity in Obese Infertile Women
An observational study of Endometrial Receptivity, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Endometrial Receptivity
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 31 May 2018to 31 Dec 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- 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)
- Conditions
- Endometrial Receptivity
- Keywords
- Endometrial microbiome, Obesity, Bacterial pathogens, Dysbiosis, Endometrial receptivity
- Medical subject headings
- Obesity, Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 months
Secondary outcomes (3)
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.
Measured: 14 months
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.
Measured: 14 months
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.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start31 May 2018
- Primary completion16 Sep 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial ReceptivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Collaborators
- IVI Bilbao, IVI Barcelona, Igenomix
- Responsible party
- Sponsor
- Investigators
- JOSE BELLVER PRADAS, MD, Principal investigator, IVIRMA VALENCIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493529
- Sponsor's protocol ID
- 1711-VLC-108-JB
- Status last verified
- Oct 2023
- First submitted
- 8 Mar 2018
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome and Endometrial Receptivity in Obese Infertile Women
- ClinicalTrials.gov ID
- NCT03493529
- Acronym / sponsor ID
- 1711-VLC-108-JB
- Conditions
- Endometrial Receptivity
- Keywords
- Endometrial microbiome, Obesity, Bacterial pathogens, Dysbiosis, Endometrial receptivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Collaborators
- IVI Bilbao, IVI Barcelona, Igenomix
- Study start
- 31 May 2018 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Microbiological analysis of saliva samples through massive sequencing.
Time frame: 14 months
Microbiological analysis of feces samples through massive sequencing.
Time frame: 14 months
Analysis of endometrial receptivity using niERA
Time frame: 13 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOSE BELLVER PRADAS, MD principal investigator
IVIRMA VALENCIA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrial Receptivity, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological analysis of endometrial fluid samples through massive sequencing (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.