Vaginal Microbiome and IVF Pregnancy Outcome

Launched by FREYA BIOSCIENCES APS · Nov 26, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the vaginal microbiome, which is the community of bacteria and other microorganisms in the vagina, to see how it might affect pregnancy outcomes for women undergoing in vitro fertilization (IVF) in the U.S. The researchers want to find out how common an imbalance in vaginal flora is among these women and if it has any impact on whether or not they become pregnant after IVF treatment.

To take part in this study, women need to be between 18 and 44 years old and planning to have a frozen embryo transfer. They should also have a healthy body weight and be able to understand the study details in English. Participants will need to provide informed consent, meaning they agree to join the study after being fully informed about what it involves. It's important to note that certain health conditions or recent use of antibiotics may disqualify some women from participating. If eligible, participants can expect to share information about their health and possibly provide samples for analysis, helping researchers learn more about how the vaginal microbiome may influence IVF success.

Gender

FEMALE

Eligibility criteria

• 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)