Vaginal Microbiome and IVF Pregnancy Outcome

Completed

Conditions studied: Vaginal Flora Imbalance

In brief

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.

Key facts

Study ID

NCT05150639

Run by

Freya Biosciences ApS

People needed

301

Starts

2022-03-18

Expected to finish

2023-05-26

Last updated by the study team

2026-03-02

Who can join

Age: 18 and older, up to 44. Sex: female. Healthy volunteers: accepted.

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)

Where it is running

• Boston IVF The Waltham Center — Waltham, Massachusetts, United States

Full record on ClinicalTrials.gov

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