The Human Microbiome and IVF Outcomes
Characterization of the Reproductive Tract and Gastrointestinal Tract Microbiome and Its Association With Pregnancy Outcomes Following Frozen Embryo Transfer
1 other identifier
observational
332
1 country
1
Brief Summary
Patients and partners undergoing an autologous IVF cycle will be recruited to participate in this prospective observational study investigating the microbiome and its association with IVF pregnancy outcomes. During the the controlled ovarian hyperstimulation cycle as well as the frozen embryo transfer cycle, a number of specimens will be collected for next generation sequencing of 16S rRNA to evaluate the microbiome profile of the reproductive and gastrointestinal tracts. Data on pregnancy outcomes will be collected prospectively and evaluated to identify associations with the microbiome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 9, 2018
CompletedStudy Start
First participant enrolled
August 13, 2018
CompletedFirst Posted
Study publicly available on registry
August 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2022
CompletedMay 3, 2023
May 1, 2023
4.2 years
August 9, 2018
May 2, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Live birth
Delivery of a live infant
10 months
Secondary Outcomes (1)
Ongoing pregnancy
2 months
Other Outcomes (3)
Number of oocytes retrieved
1 month
Fertilization rate
1 month
Blastulation rate
1 month
Interventions
Specimens collected from patients will be used for next generation sequencing of the bacteria-specific 16S rRNA gene
Eligibility Criteria
Patients and partners undergoing IVF
You may qualify if:
- Patients initiating an autologous IVF cycle
- Patient age 18-45; partner age 18-60
- Partner planning to provide fresh semen sample on day of oocyte retrieval
- Patients planning to undergo preimplantation genetic screening (PGS) of embryos with single embryo transfer (SET)
You may not qualify if:
- \> 1 prior failed IVF cycle
- Third party reproduction
- Planning to bank embryos
- Partner using cryo sperm or surgical sperm on day of retrieval
- Male or female partner antibiotic use within 1 month of IVF cycle start
- Mullerian anomalies, excluding arcuate uterus
- Submucosal fibroids
- History of uterine surgery, excluding polypectomy, D\&C, and Cesarean section
- Communicating hydrosalpinx without plans for surgical correction prior to embryo transfer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IVI RMA New Jersey
Basking Ridge, New Jersey, 07920, United States
Biospecimen
Serum, urine, buccal, cervical, vaginal, rectal, semen, embryo transfer catheter tip
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Franasiak, MD
Reproductive Medicine Associates of New Jersey
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2018
First Posted
August 20, 2018
Study Start
August 13, 2018
Primary Completion
October 11, 2022
Study Completion
December 15, 2022
Last Updated
May 3, 2023
Record last verified: 2023-05