RECRUITING

Vaginal Microbiome and IVF Pregnancy Outcome

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Conditions

Vaginal Flora Imbalance

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-03-18
Study Completion:2024-01-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05150639

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 44 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18-44 years
  2. * 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.
  3. * Women undergoing a planned frozen embryo transfer
  4. * BMI between 18.5-35 kg/m2 (both included)
  5. * Must be able to understand and read the informed consent form in English.
  1. * Current diagnosis of pathologies or malformations that affect the uterine cavity such as polyps, intramural myoma, adhesions, fibroids or hydrosalpinx.
  2. * 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.
  3. * 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.
  4. * Systemic and/or vaginally applied antibiotic use within the last month prior to screening (except for prophylactic antibiotics related to egg retrieval).
  5. * Patients utilizing oral contraceptive pills in the past month
  6. * Latex or silicone allergy (Diva Cup and Vaginal Disc)

Contacts and Locations

Study Contact

Kristin Rooney
CONTACT
4346470
kRooney@bostonivf.com
Denny Sakkas, PhD
CONTACT
4346500
DSakkas@BOSTONIVF.com

Principal Investigator

Denis Vaughan, PhD
PRINCIPAL_INVESTIGATOR
Boston IVF
Denny Sakkas, PhD
PRINCIPAL_INVESTIGATOR
Boston IVF

Study Locations (Sites)

Boston IVF The Waltham Center
Waltham, Massachusetts, 02451
United States

Collaborators and Investigators

Sponsor: Freya Biosciences ApS

  • Denis Vaughan, PhD, PRINCIPAL_INVESTIGATOR, Boston IVF
  • Denny Sakkas, PhD, PRINCIPAL_INVESTIGATOR, Boston IVF

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-18
Study Completion Date2024-01-15

Study Record Updates

Study Start Date2022-03-18
Study Completion Date2024-01-15

Terms related to this study

Additional Relevant MeSH Terms

  • Vaginal Flora Imbalance