Vaginal Microbiome and IVF Pregnancy Outcome

NCT05150639 | Completed

• 1 other identifier: IVF-2
• Study Type: observational
• Target: 301
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vaginal Flora Imbalance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Associations of microbiome

  Evaluated from sample collected 1 week prior to frozen embryo transfer and correlated with pregnancy outcomes obtained up until birth

Interventions

IVF OTHER

Women planning to undergo frozen embryo transfer IVF procedure will be included. Samples will be obtained, but no study intervention will be applied. Pregnancy outcome data will be obtained, following frozen embryo transfer, to correlate against other data from samples (vaginal microbiome etc).

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Freya Biosciences ApS: lead
• Boston IVF: collaborator

Study Sites (1)

Boston IVF The Waltham Center

Waltham, Massachusetts, 02451, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples collected will be: Vaginal swabs Vaginal secretion Urine Menstrual effluent (optional) Peripheral blood (optional)

Study Officials

• Denis Vaughan, PhD

  Boston IVF

  PRINCIPAL INVESTIGATOR

• Denny Sakkas, PhD

  Boston IVF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 9, 2021
• Study Start: March 18, 2022
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)