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| Name | Class |
|---|---|
| Boston IVF | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IVF | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Women planning to undergo frozen embryo transfer IVF treatment at Boston IVF fertility clinic in Boston, US.
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| Name | Affiliation | Role |
|---|---|---|
| Denis Vaughan, PhD | Boston IVF | Principal Investigator |
| Denny Sakkas, PhD | Boston IVF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston IVF The Waltham Center | Waltham | Massachusetts | 02451 | United States |
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Samples collected will be:
Vaginal swabs Vaginal secretion Urine Menstrual effluent (optional) Peripheral blood (optional)