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The Human Microbiome and IVF Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03637777
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

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.

Condition or disease Intervention/treatment
Infertility Diagnostic Test: 16S rRNA gene sequencing

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of the Reproductive Tract and Gastrointestinal Tract Microbiome and Its Association With Pregnancy Outcomes Following Frozen Embryo Transfer
Actual Study Start Date : August 13, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Intervention Details:
  • Diagnostic Test: 16S rRNA gene sequencing
    Specimens collected from patients will be used for next generation sequencing of the bacteria-specific 16S rRNA gene

Primary Outcome Measures :
  1. Live birth [ Time Frame: 10 months ]
    Delivery of a live infant

Secondary Outcome Measures :
  1. Ongoing pregnancy [ Time Frame: 2 months ]
    Presence of fetal heart beat at 8 weeks' gestation

Other Outcome Measures:
  1. Number of oocytes retrieved [ Time Frame: 1 month ]
    Number of oocytes retrieved

  2. Fertilization rate [ Time Frame: 1 month ]
    Number of 2PNs/number of inseminated M2s

  3. Blastulation rate [ Time Frame: 1 month ]
    Number of blastocysts/number of 2PNs

Biospecimen Retention:   Samples With DNA
Serum, urine, buccal, cervical, vaginal, rectal, semen, embryo transfer catheter tip

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients and partners undergoing IVF

Inclusion Criteria:

  1. Patients initiating an autologous IVF cycle
  2. Patient age 18-45; partner age 18-60
  3. Partner planning to provide fresh semen sample on day of oocyte retrieval
  4. Patients planning to undergo preimplantation genetic screening (PGS) of embryos with single embryo transfer (SET)

Exclusion Criteria:

  1. > 1 prior failed IVF cycle
  2. Third party reproduction
  3. Planning to bank embryos
  4. Partner using cryo sperm or surgical sperm on day of retrieval
  5. Male or female partner antibiotic use within 1 month of IVF cycle start
  6. Mullerian anomalies, excluding arcuate uterus
  7. Submucosal fibroids
  8. History of uterine surgery, excluding polypectomy, D&C, and Cesarean section
  9. Communicating hydrosalpinx without plans for surgical correction prior to embryo transfer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03637777

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Contact: Christine Whitehead, BSN, RN 973-656-2841

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United States, New Jersey
IVI RMA New Jersey Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Christine V Whitehead, BSN,RN    973-656-2841   
Principal Investigator: Jason M Franasiak, MD         
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
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Principal Investigator: Jason Franasiak, MD Reproductive Medicine Associates of New Jersey

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Responsible Party: Reproductive Medicine Associates of New Jersey Identifier: NCT03637777     History of Changes
Other Study ID Numbers: RMA-2017-03
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: August 20, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Genital Diseases, Male
Genital Diseases, Female