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| Name | Class |
|---|---|
| Statens Serum Institut | OTHER |
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The investigators aim to examine the endometrium with state of the art sequencing techniques to investigate the endometrial microbiota. The endometrial microbiota has been perceived to be sterile, however, this seems incorrect from recent studies. Thus, the primary outcome is to compare the rate of ascending infection from the semen to the vagina to the endometrium and to investigate which bacteria are capable of inhabiting these environments. Furthermore, cervical mucus will be obtained in order to test for immunological, microbiological and mechanical properties that may be involved in ascending infection. Finally, the study aim to characterize the temporal changes in the vaginal microbiota during estrogenic treatment with Estrofem® or Vivelle Dot (R) for preparation of the endometrium prior to embryo transfer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal microbiota | Based on qPCR and Next gen sequencing | ||
| Abnormal microbiota | Based on qPCR and Next gen sequencing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estrofem | Drug | Patients will be asked to obtain self-collected vaginal swabs from the mid-vagina from the beginning of their Estrofem® treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of ascending infection/sharing of bacteria in the genital tract | Seminal, vaginal, cervical and endometrial samples will be compared at the time of oocyte retrieval. | This outcome data is measured at the day of oocyte retrieval. |
| Measure | Description | Time Frame |
|---|---|---|
| Next generation sequencing techniques will be used to assess the vaginal microbiota.I.e. measure of relative abundances | Vaginal microbiota changes throughout the preparation of the endometrium for frozen embryo transfer. | Examined longitudinally throughout the segmentation cycle. The estimated time to event is 40 days from oocyte retrieval until frozen embryo transfer following a strict protocol. |
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Inclusion Criteria:
Exclusion Criteria:
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Infertile couples attending IVF treatment and referred to a segmentation protocol.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fertility Clinic Skive | Skive | 7800 | Denmark | |||
| The Fertility Clinic, Regional Hospital of Skive |
Part of PhD project. Data will appear in the thesis and subsequent publications.
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C044003 | estradiol, estriol drug combination |
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Vaginal, cervical and endometrial. Also semen of patients with male partner.
| qPCR to assess the vaginal microbiota. I.e. a quantitative measure Copies/mL. | Vaginal microbiota changes throughout the preparation of the endometrium for frozen embryo transfer. | Examined longitudinally throughout the segmentation cycle. The estimated time to event is 40 days from oocyte retrieval until frozen embryo transfer following a strict protocol. |
| Number of participants with a Clinical pregnancy | Tested by clinical pregnancy scan by ultrasound in week 7-9 | 7-9 weeks after inclusion. |
| Number of participants with a Live birth | Tested by self-reported schemes | 36-42 weeks after inclusion |
| Skive |
| 7800 |
| Denmark |
| D000091662 | Genital Diseases |
| D007246 | Infertility |