An observational study in Infertility of Uterine Origin, sponsored by Igenomix. Completed at 13 sites in 8 countries. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-09.
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Among 44 studies in Dysbiosis with a site in United States — 14 open to participants now, 20 under way, none of them phase 3. Dysbiosis · United States.
Among the 44 studies in Dysbiosis with a site in United States, this one is one of 2 that started in 2017, is one of 8 observational ones, and was the 6th registered.
188 studies on the registry are indexed under Dysbiosis; 65 are open to participants now.
Browse Dysbiosis studies →14 of the 44 studies in Dysbiosis with a site in United States are open now. Recruiting first, the newest first:
Florida State University · Sites in United States
Ages 6–13 · Healthy volunteers
Florida State University · Sites in United States
Ages 6–13 · Healthy volunteers
Freya Biosciences ApS · Sites in United States
Ages 18–45 · Women only
University of California, Davis · Sites in United States
Ages 45–70 · Healthy volunteers
Florida State University · Sites in United States
Ages 6–13 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 42 Dysbiosis studies recruiting now, 14 (33%) set no upper age limit and 25 (60%) stop at 75 or younger; 11 take children under 18; 19 take healthy volunteers.
This study: 18 Years to 50 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
44 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 5 · Phase 4 5
First in 2009; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 452 is above the median of 86 across 52 observational studies indexed under Dysbiosis.
Median enrollment 48 across the 35 interventional studies, 58 across the 8 observational. Of the 21 that completed or were terminated, 6 (29%) have results posted.
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4 of 44 have an industry lead sponsor. The 10 most frequent:
This study is registered under Igenomix, one of the names counted as Vitrolife. Under that name alone:
Igenomix is the lead sponsor of 31 studies on the registry; 3 are open to participants now.
Vitrolife has 2 studies filed under Dysbiosis — fewer than ten, so there is no comparison to draw.
8 of the studies in Dysbiosis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06544954University of California, DavisPrebiotic Effects of California Grapes on Gut Health and Cardiometabolic Health in Overweight Men and Women | 2026-11 |
| NCT06588218Florida State UniversityEffect of Watermelon on Gut and Cardiometabolic Health | 2026-12 |
| NCT05288790Vanderbilt University Medical CenterMicrobiome Metabolites and Alcohol in HIV to Reduce CVD RCT | 2027-03-31 |
| NCT06916936Florida State UniversityEffect of Peanut Butter on Gut and Metabolic Health | 2027-05 |
| NCT06636669Boston Medical CenterProbiotics in the Prevention of Recurrent Prosthetic Joint Infection of the Hip and Knee | 2027-06 |
Add all 8 to your calendar (.ics) → With an account.
Among the 44 studies in Dysbiosis with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
Although the endometrium tissue has been traditionally considered free of bacteria, recent studies have documented the presence of an endometrial microbiome. In a pilot study conducted by our research team, the microorganisms present in the endometrium were analysed in samples of endometrial fluid (EF) using next generation sequencing (NGS).Consistent with previously published studies, in normal conditions the endometrium is mainly composed of different species of the genus Lactobacillus. It was further noted that the presence of other pathogenic bacteria such as Streptococcus, and/or Gardnerella may alter the endometrial microbiome and can disrupt the uterine environment, affecting implantation rates and pregnancy success.
This project aims to validate the microbiome found in the endometrium of women of reproductive age and try to corroborate the relationship between the endometrial microbiome and the reproductive outcomes in patients undergoing assisted reproduction treatment (ART). The use of Endometrial Receptivity Analysis (ERA) tool, together with the analysis of the endometrial flora before the embryo transfer will allow to evaluate the impact of the presence of endometrial pathogens on implantation in receptive patients.
Therefore, the focus of this project is the development and clinical validation of a non-invasive diagnosis tool to analyse the microbiota, adding the microbiome study to the ERA analysis.
Embryonic implantation is a critical process to the survival of the species that is relatively inefficient, especially in humans. Key elements are the embryo, the maternal endometrium, and the cross-communication between them using different scientific perspectives. Endometrial receptivity describes the phenotype that allows embryo adhesion and placentation to occur. Due to the need of an accurate and objective molecular diagnostic test for the receptivity status of endometrium, the Endometrial Receptivity Analysis (ERA) was developed. ERA test is a customized expression microarray that identifies the transcriptomic expression profile signature of the personalized window of implantation (WOI). Its clinical usefulness has been demonstrated in patients with implantation failure in whom 25% of them have a displaced WOI becoming pregnant once the embryo transfer is performed at the proper WOI predicted by ERA. However, this procedure requires an endometrial biopsy (EB), which is the major drawback of this diagnosis test, because embryo transfer has to be delayed to the next cycle, and also the possible discomforts caused to the patients. For this reason, a previous pilot study was conducted in order to confirm whether endometrial receptivity can be predicted through non-invasive methods in endometrial fluid (EF) samples. The gene panel of ERA test was interrogated on epithelial and stromal cells from endometrial biopsies and cells isolated from the EF at the single cell level, demonstrating that the major cells on the EF classifies together with the epithelial population.
On the other hand, to try to better understand the mechanisms that connect endometrial receptivity and/or implantation of the embryo with an altered endometrial microbiome, another pilot study was conducted to determine the composition of the endometrial microbiome after the analysis of the bacterial 16S ribosomal RNA by NGS. Interestingly, in patients with receptive endometrium, diagnosed by Endometrial Receptivity Array (ERA) who had endometrial microbiome with pathogens, or not dominated by bacteria of the genus Lactobacillus (NLD) showed significantly lower implantation (23.1% vs 60.7% p = 0.02), pregnancy (33.3% vs 70.6%, p = 0.03), ongoing pregnancy per embryo transfer (13.3% vs 58.8%, p = 0.03), and live birth (6.7% vs 58.8%, p = 0.002) rates than those with a healthy endometrial microbiome dominated by Lactobacillus (LD). Moreover, this relationship was much more significant when pathogenic species found belonged to the genus Gardnerella and Streptococcus. This is in line with other published studies that analyze the impact of endometrial pathogens in IVF treatments, highlighting the importance of the study of bacterial communities for reproductive health.
Given these preliminary results, the present study aims to validate in a larger sample set, the relationship between the imbalance of endometrial microbiome and the decline in reproductive success in patients undergoing ART. To do this, the experimental design will be improved in the following areas: (i) a higher sample size will be analysed to validate the previous results obtained in the previous pilot study on endometrial microbiome, (ii) paired samples from endometrial fluid and endometrial biopsy will be analysed for the microbial profile to study whether there is bacterial variability associated to the sample type, (iii) the endometrial microbiota will be simultaneously assessed with ERA as a supplementary diagnosis for this tool, and (iv) the analysis of the endometrial microbiota will be performed using the most advanced technology on bacterial metagenome sequencing to widen the information of the microorganisms identified in each sample.
ART patients, with indication of diagnosis of endometrial receptivity by ERA that will receive embryo transfer with frozen blastocyst stage embryos (day 5/day 6).
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.
Exclusion Criteria:
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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 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 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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Receptive patients by the ERA test with an endometrial microbiota mainly composed of different species of the genus Lactobacillus, determined by NGS sequencing.
Procedure: Endometrial biopsy and endometrial fluid collection
Receptive patients by the ERA test with an endometrial microbiota composed of different pathogenic bacteria such as Streptococcus and Gardnerella, or not dominated by bacteria of the genus Lactobacillus, determined by NGS sequencing.
Procedure: Endometrial biopsy and endometrial fluid collection
On the same day that the EB for ERA is indicated, in day 5 of a HRT cycle with 5 days of progesterone, according to the common clinical practice, a sample of EF will be aspirated immediately prior to EB for ERA. This EF sample will be used for the non-invasive diagnosis of the microbiome, also a small portion of the endometrial tissue obtained for the endometrial receptivity diagnosis by ERA will be used as a control for the study of the endometrial microbiome. Those patients with a receptive endometrium will continue their ART according to the standard clinical protocol. Those patients with non-receptive endometrium will follow the recommendation derived of the ERA test for the election of the day for a second EB sample, in which the collection of EF sample will be repeated. Finally, the receptivity and microbiome results in EF will be correlated with that on the endometrial tissue, and with the reproductive outcomes of these patients after the embryo transfer.
Development of a new non-invasive diagnosis test of Endometrial Microbiome (EM) in infertile patients
Bacterial DNA analysis by Next Generation Sequencing (NGS) using endometrial fluid for the EM diagnose. This will be measured by the percentage of each bacterial DNA in EF samples
Time frame: 24 months
Live birth rate
Number of babies born per embryo transfer
Time frame: 40 weeks
Implantation rate
Number of implanted embryos per total number of embryos transferred
Time frame: 12 weeks
Pregnancy rate
Number of pregnancies per embryo transfer
Time frame: 20 weeks
Biochemical pregnancies
Number of biochemical pregnancies per total number of pregnancies
Time frame: 20 weeks
Ectopic pregnancies
Number of ectopic pregnancies per total number of pregnancies
Time frame: 20 weeks
Clinical miscarriages
Number of clinical miscarriages per total number of pregnancies
Time frame: 20 weeks
Ongoing pregnacy rate
Number of ongoing pregnancies per embryo transfer
Time frame: 40 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2017 to primary completion in May 2019, 21 months.
Of 29 observational studies under Dysbiosis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's 21 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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