We're launching a study to better understand how the microbiome may impact IVF treatment.
Going through IVF? Your participation could contribute to science to better understand how the vaginal and gut microbiome may impact IVF treatment. In partnership with Matthew Foley, Ph.D., we intend to publish our findings when the study concludes.
19-26% of women face challenges related to reproductive and fertility outcomes.
12% of women experiencing infertility turn to assisted reproductive treatments, predominantly in vitro fertilization (IVF). This results in an astounding 400,000 IVF cycles per year nationwide[1].
Research has shown an association between the gut and vaginal microbiomes and a variety of pregnancy complications such as gestational diabetes, pre-term labor, and preeclampsia[2]. An imbalance in the delicate vaginal ecosystem can also impact fertility outcomes and IVF success[3], various studies have found that a vaginal microbiome dominated by Lactobacillus species to be significantly associated with successful conception and healthy pregnancies[4],[5],[6].
The goal of this study is to assess how the vaginal and gut microbiome may impact IVF outcomes. Adult participants, who are undergoing IVF treatment and purchase a Tiny Health vaginal or vaginal + gut test, may consent to have their data used in this study. Each participant will agree to fill out a survey on pregnancy outcomes after implantation results are known.
By Matthew Foley, Ph.D.
IRB ID: 12035
Read more about current research surrounding the microbiome and IVF success in our latest Tiny Blog Post: The Unexpected Role of the Vaginal and Endometrial Microbiomes in Fertility and IVF Success
Help Contribute to Advance Fertility Research
Get the valuable insights of vaginal microbiome testing and help us to better understand the connection between vaginal health and IVF success.
Am I eligible to participate?
Inclusion criteria
- Open to Tiny Health Customers
- Participants are qualified for this study if they are 18+ at the time of enrollment and under the age of 39
- Participants must be residents of the United States with US postal service
- Participants must be transferring a screened euploid embryo
- Microbiome testing must be within 3 months of the embryo transfer
Exclusion criteria
- Participants cannot have had any fertility factors identified
- Participants cannot have taken any antibiotics within the last 6 months
- Participants cannot have any existing health conditions:
- Pre-existing vaginal conditions
- Pre-existing gut conditions (IBS, IBD, Celiac's, etc)
- Immune or auto-immune conditions (severe combined immunodeficiency (SCID), human immunodeficiency virus (HIV))
- Participants must not smoke
Track your baby's microbiome development over time
You can learn the most about your baby’s health and protect against chronic conditions by tracking changes on their gut health over their first 1000 days.
We recommend testing at 7 days old, and every 3 months until your baby is 18 months old.
A Tiny Health subscription gets you:
- Exclusive $30 discount off each test kit
- Your kits delivered when you need them
- Enter your payment details only once
- Pay only when the tests are shipped
- Free shipping
- Skip or cancel anytime
How to Join the Study
If you are interested, please complete the survey. This study is only open to Tiny Health customers. Qualified individuals can enroll and consent to the study when registering their kit.
- 1x Mess-free vaginal microbiome health test
- Vaginal CST identity to assess vaginal health
- Vaginal health report with personalized recommendations (delivered in 4-5 weeks)
- 1x Mess-free vaginal microbiome health test
- 1x Mess-free gut microbiome health test to further understand how gut health relates to fertility and IVF success
- Vaginal CST identity to assess vaginal health
- Track essential bacteria that you should pass during birth to your baby and levels of bacteria that support metabolic health and fight inflammation
- Vaginal Health Report and Gut Health Report with personalized recommendations (delivered in 4-5 weeks)
Track your baby's microbiome development over time
You can learn the most about your baby’s health and protect against chronic conditions by tracking changes on their gut health over their first 1000 days.
We recommend testing at 7 days old, and every 3 months until your baby is 18 months old.
A Tiny Health subscription gets you:
- Exclusive $30 discount off each test kit
- Your kits delivered when you need them
- Enter your payment details only once
- Pay only when the tests are shipped
- Free shipping
- Skip or cancel anytime
How to Join the Study
If you are interested, please complete the survey. This study is only open to Tiny Health customers. Qualified individuals can enroll and consent to the study when registering their kit.
- 1x Mess-free vaginal microbiome health test
- Vaginal CST identity to assess vaginal health
- Vaginal health report with personalized recommendations (delivered in 4-5 weeks)
- 1x Mess-free vaginal microbiome health test
- 1x Mess-free gut microbiome health test to further understand how gut health relates to fertility and IVF success
- Vaginal CST identity to assess vaginal health
- Track essential bacteria that you should pass during birth to your baby and levels of bacteria that support metabolic health and fight inflammation
- Vaginal Health Report and Gut Health Report with personalized recommendations (delivered in 4-5 weeks)
How to join the study
If you are interested, please complete the survey. If you qualify for the study, a clinical coordinator will meet with you virtually to enrol you in the study and sign consent forms.
Tiny Health was created for mom and baby
Tiny Health offers at-home gut tests for the whole family. We focus on a baby’s first 1,000 days to address imbalances that may cause chronic conditions such as allergies. Processed in a CLIA-certified lab and using comprehensive shotgun metagenomics sequencing, Tiny Health gives parents personalized insights and evidence-based recommendations to improve a baby’s lifelong health.
Tiny Health’s mission is to improve health outcomes of future generations through evidence-based insights.
Our research partner develops virome therapeutics
It's not only about the bacteria...
At least half of the microbiome is made up of viruses, which can infect and kill beneficial bacteria, contributing to dysbiosis and disease. The "virome" is the term coined for the collection of all viruses within your microbiome.
Our research partner, Dr. Foley, represents a virome therapeutics company that seeks to investigate which viral profiles shape the bacterial community and impact IVF outcomes.
IRB ID# 12035
How does the Research Edition work?
Purchase the kits, sample, and complete surveys
This study is open to people who have purchased a Tiny Health Vaginal Test or Gut Health Test.
Complete the qualification survey via the button on this page to see if you qualify.
If you qualify for the study, you will receive a link to purchase a Research Edition Tiny Health Vaginal Health test or a combination Tiny Health Vaginal Health and Tiny Health Gut Health test at a discount.
To investigate the important connection between IVF success and gut health, participants must also agree to complete a short survey approximately 4-8 weeks after embryo transfer to share pregnancy results.
Both vaginal and gut samples can be taken at home by using our swab method. Samples will be mailed in using a prepaid envelope provided with the kit.
You will fill out health history and sample surveys upon sampling.
Processed in a CLIA-certified lab and using proprietary technology, Tiny Health’s vaginal health test and gut health test provides strain-level precision and a complete list of all microbes in the vaginal and gut microbiome including bacteria, fungi, virus, parasites, and archaea. Results will take 4-5 weeks to arrive.
Consent to the study
The Fertility Study research edition is suitable for individuals who are undergoing IVF treatment with a clinic (must provide supporting documentation).
- Participants should take microbiome samples within 3 months BEFORE transferring a screened euploid embryo.
- Participants must have no known male or other fertility factor identified.
Receive test results & complete the survey
Every report includes key insights and metrics that are reviewed by a team of microbiome experts.
- Tiny Health also provides actionable and evidence-based recommendations to people trying to conceive, are currently pregnant, or postpartum.
- The microbiome result report and action plan are a part of the regular Tiny Health Vaginal and Gut Health Test product and not associated with the research study.
To study important connections between the microbiome and IVF success, it is critical that participants complete a follow up survey after embryo transfer on pregnancy results.
Participants who have consented to the study will receive a link to this follow up survey via email.
How do we look at the microbiome?
High resolution analysis
We use shotgun metagenomics, a technology used in microbiome research. Make informed decisions with a comprehensive list of microbes found in your sample.
Functional insights
Through functional profiling, we tell you what microbes are present, how much of them are there, and what they’re actually doing.
Targeted suggestions
Get actionable advice tailored to your age and unique test results. Our at-home tests empower you with strain-level detail and precision science.
Your privacy comes first
We are dedicated to safeguarding your personal information at every turn and we will never sell your personal information. Your data is encrypted with high security standards to ensure complete confidentiality.
CLIA & CAP certified lab
Your samples are processed at a U.S. clinical-grade lab to ensure the accuracy, reliability, and timeliness of test results.
Meet our supporters:
Medical Advisors
Professor Emeritus of Microbiology & Immunology, Cornell University
Assistant Professor of Medicine, Center for Individualized Medicine Microbiome Program, Mayo Clinic, Rochester, MN
Medical Advisor; Practicing OB/GYN Hospitalist Physician, Creator and Host of The All About Pregnancy & Birth Podcast
Associate Professor of Pediatrics and Child Health at the University of Manitoba; Co-Director, Manitoba Interdisciplinary Lactation Center (MILC); Deputy Director, CHILD Cohort Study
Associate Clinical Professor, UCSF; Pediatrician and former Chief Innovation Officer, Kaiser Permanente
Board-Certified Pediatrician, Creator of Raising Amazing Podcast
Integrative Pediatrician and Pediatric Functional Medicine Expert
Founder, Healthy Kids Happy Kids
Instituto de Medicina Molecular Faculty of Medicine, University of Lisbon
Associate Professor of Epidemiology, Johns Hopkins University
Interested? Join this study
If you are interested, please complete the survey. Qualified individuals will be contacted by the study coordinator to provide consent and enroll in the study.
Frequently Asked Questions
Data exposure: Tiny Health will collect personal identification information such as names, emails, addresses, and health information via online surveys. The risk of personal information or microbiome data being exposed is a possibility. To prevent this risk, all personal information is stored in encrypted databases with access limited to dual authentication select employees. Stool samples are de-identified using a kit id before being sent to partners for DNA extraction and sequencing.
While microbiome testing does not diagnose fertility factors, we can show associations between your vaginal microbiome and vaginal health.
How do we do this? We use the relative abundance of key bacteria as indicators of vaginal health. These evaluations are developed through research. The Tiny Health Bioinformatics Pipeline uses a custom built database of over 120K complete microbial genomes. We sift through the research surrounding the microbiome and use this information to develop a list of bacteria that we feel are important to vaginal health.
Beyond the vaginal and gut microbiome, there are a lot of factors that can contribute to fertility status.
It's important to the study that vaginal and gut samples are taken within 3 months BEFORE embryo transfer. However, this study will continue until June 2025, so please return when qualified to be eligible for this research edition discounted kit.