Vaginal Microbiome and IVF Pregnancy Outcome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-18

Study Completion Date

2024-01-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Vaginal Flora Imbalance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes