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Bacteria balance may predict IVF success

NCT ID NCT05150639

Knowledge-focused Sponsor: Freya Biosciences ApS Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study examined the link between vaginal bacteria and pregnancy outcomes in 301 women undergoing frozen embryo transfers. Researchers measured the prevalence of vaginal dysbiosis (imbalance) and compared pregnancy rates between those with and without it. The goal was to understand how the vaginal microbiome influences IVF success, without providing any treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

301 people

The number who actually took part.

Started

Mar 2022

Finished

May 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 44 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Vaginal flora imbalance

Contacts and locations

Locations

  • Boston IVF The Waltham Center

    Waltham, Massachusetts, 02451, United States

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