Vaginal Microbiome and IVF Pregnancy Outcome

Last updated: September 12, 2023
Sponsor: Freya Biosciences ApS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaginal Infection

Treatment

IVF

Clinical Study ID

NCT05150639
IVF-2
  • Ages 18-44
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 studyand voluntarily accepted to participate after being fully aware of the potentialrisks, 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

Exclusion Criteria:

  • Current diagnosis of pathologies or malformations that affect the uterine cavity suchas polyps, intramural myoma, adhesions, fibroids or hydrosalpinx.
  • Any illness or medical condition that is unstable or which, according to medicalcriteria and Investigator's discretion may put at risk the patient's safety and hercompliance in the study.
  • Participants currently taking antibiotics or with any known condition requiringregular use of antibiotics, that would suggest the participant is likely to needantibiotic treatment during the observational period of this study.
  • Systemic and/or vaginally applied antibiotic use within the last month prior toscreening (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 Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: IVF
Phase:
Study Start date:
March 18, 2022
Estimated Completion Date:
January 15, 2024

Study 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.

Connect with a study center

  • Boston IVF The Waltham Center

    Waltham, Massachusetts 02451
    United States

    Active - Recruiting

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