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
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
Connect with a study center
Boston IVF The Waltham Center
Waltham, Massachusetts 02451
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.