Characterization of the Reproductive Tract and Gastrointestinal Tract Microbiome and Its Association With Pregnancy Outcomes Following Frozen Embryo Transfer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 332
- Locations
- 1
- Primary Endpoint
- Live birth
Study Overview
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.
Detailed Description
PURPOSE OF STUDY
To characterize the microbiome of the female reproductive tract and gastrointestinal tract as well as the male reproductive tract in patients and partners undergoing IVF and determine if there are any associations with pregnancy outcomes.
The Clinical Problem
The microbiome of the reproductive tract and its association with reproductive outcomes is a topic of evolving interest. Alterations in the vaginal microbiome have been linked to obstetric complications including miscarriage and preterm birth. More recent data have emerged linking the vaginal microbiome to assisted reproductive technology (ART) outcomes. A prospective observational study consisting of 30 patients who had swabs collected at various time points during the in vitro fertilization-embryo transfer (IVF-ET) cycle for sequencing of the 16S ribosomal RNA gene concluded that the species diversity of the vaginal microbiome distinguished women who had a live birth from those who did not with increased diversity being associated with poorer outcomes; however, the patient population was heterogeneous and small.
Limited information is available regarding the microbiome of the upper genital tract and its association with reproductive outcomes, particularly in the setting of ART. Studies done solely for the purpose of characterizing the upper genital tract microbiome have relied on hysterectomy specimens to assess colonization, thus precluding evaluation of any association with reproductive outcomes. Perhaps the first study to investigate the association between the microbiome of the upper reproductive tract and ART outcomes utilized culture-based technology on embryo transfer catheter tips. However, this study utilized culture-based technology, with only four major bacteria were reported. Subsequent studies have highlighted the limitations of culture-based technology, namely that it is reliant upon successful culture, often resulting in an underestimate of the diversity of organisms.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Exclusion Criteria
- •> 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
Outcomes
Primary Outcomes
Live birth
Time Frame: 10 months
Delivery of a live infant
Secondary Outcomes
- Ongoing pregnancy(2 months)