Vaginal Microbiome and IVF Pregnancy Outcome

Associations Between the Vaginal Microbiome, Inflammatory Status and Pregnancy Outcome - a Prospective, Observational Study in Women Undergoing Frozen Embryo Transfers.

The aim of this prospective, observational study is to investigate the prevalence of vaginal dysbiosis among women undergoing IVF procedures in the US. And to investigate the associations between the vaginal microbiome and the pregnancy outcome following IVF.

Study Overview

• Status: Recruiting
• Conditions: Vaginal Flora Imbalance
• Intervention / Treatment: Other: IVF

Detailed Description

The present study will evaluate differences in vaginal microbiome composition in pregnant and non pregnant women who have undergone IVF treatment with frozen embryo transfer. Concurrently we aim to identify whether menstrual tissue and Cervicovaginal secretion possess complimentary biomarker information reflecting the immune/inflammatory status of the reproductive tract to determine its impact on pregnancy success following frozen embryo transfer IVF procedure.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Kristin Rooney; Phone Number: 781 4346470; Email: kRooney@bostonivf.com
• Study Contact Backup: Name: Denny Sakkas, PhD; Phone Number: 781 4346500; Email: DSakkas@BOSTONIVF.com

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • Recruiting
      • Boston IVF The Waltham Center
      • Contact: Kristin Rooney; Phone Number: 781 781-434-6470; Email: kRooney@bostonivf.com
      • Contact: Denny Sakkas, PhD; Phone Number: 781 7814346500; Email: DSakkas@BOSTONIVF.com
      • Principal Investigator: Denny Sakkas, PhD
      • Principal Investigator: Denis Vaughan, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Women planning to undergo frozen embryo transfer IVF treatment at Boston IVF fertility clinic in Boston, US.

Description

Inclusion Criteria:

• Age 18-44 years
• Patients whose written informed consent approved by the Institutional Review Board (IRB) has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.
• Women undergoing a planned frozen embryo transfer
• BMI between 18.5-35 kg/m2 (both included)
• Must be able to understand and read the informed consent form in English.

Exclusion Criteria:

• Current diagnosis of pathologies or malformations that affect the uterine cavity such as polyps, intramural myoma, adhesions, fibroids or hydrosalpinx.
• Any illness or medical condition that is unstable or which, according to medical criteria and Investigator's discretion may put at risk the patient's safety and her compliance in the study.
• Participants currently taking antibiotics or with any known condition requiring regular use of antibiotics, that would suggest the participant is likely to need antibiotic treatment during the observational period of this study.
• Systemic and/or vaginally applied antibiotic use within the last month prior to screening (except for prophylactic antibiotics related to egg retrieval).
• Patients utilizing oral contraceptive pills in the past month
• Latex or silicone allergy (Diva Cup and Vaginal Disc)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of vaginal dysbiosis	The prevalence (evaluated as % of included population) of vaginal dysbiosis in women undergoing frozen embryo transfer IVF treatment in the US	Evaluated from sample collected 1 week prior to frozen embryo transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Associations of microbiome	The difference in pregnancy success rates (biochemical pregnancy, clinical pregnancy and live birth) following frozen embryo transfer in women with versus without vaginal dysbiosis	Evaluated from sample collected 1 week prior to frozen embryo transfer and correlated with pregnancy outcomes obtained up until birth

Collaborators and Investigators

• Sponsor: Freya Biosciences ApS
• Collaborators: Boston IVF
• Investigators: Principal Investigator: Denis Vaughan, PhD, Boston IVF; Principal Investigator: Denny Sakkas, PhD, Boston IVF

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2022
• Primary Completion (Actual): May 26, 2023
• Study Completion (Estimated): January 15, 2024

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IVF-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No