Vaginal Microbiome and IVF Pregnancy Outcome

Vaginal Flora Imbalance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05150639
• Other study ID #: IVF-2
• Status: Recruiting
• Start date: March 18, 2022
• Est. completion date: January 15, 2024

Study information

• Verified date: September 2023
• Source: Freya Biosciences ApS
• Contact: Kristin Rooney
• Phone: 4346470
• Email: kRooney[@]bostonivf.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

The present study will evaluate differences in vaginal microbiome composition in pregnant and non pregnant women who have undergone IVF treatment with frozen embryo transfer. Concurrently we aim to identify whether menstrual tissue and Cervicovaginal secretion possess complimentary biomarker information reflecting the immune/inflammatory status of the reproductive tract to determine its impact on pregnancy success following frozen embryo transfer IVF procedure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 15, 2024
• Est. primary completion date: May 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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)

Related Conditions & MeSH terms

• Vaginal Flora Imbalance

Intervention

Other:
• IVF
Women planning to undergo frozen embryo transfer IVF procedure will be included. Samples will be obtained, but no study intervention will be applied. Pregnancy outcome data will be obtained, following frozen embryo transfer, to correlate against other data from samples (vaginal microbiome etc).

Locations

Country	Name	City	State
United States	Boston IVF The Waltham Center	Waltham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Freya Biosciences ApS	Boston IVF

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of vaginal dysbiosis	The prevalence (evaluated as % of included population) of vaginal dysbiosis in women undergoing frozen embryo transfer IVF treatment in the US	Evaluated from sample collected 1 week prior to frozen embryo transfer
Secondary	Associations of microbiome	The difference in pregnancy success rates (biochemical pregnancy, clinical pregnancy and live birth) following frozen embryo transfer in women with versus without vaginal dysbiosis	Evaluated from sample collected 1 week prior to frozen embryo transfer and correlated with pregnancy outcomes obtained up until birth