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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Statens Serum Institut | OTHER |
| Stork Fertility Clinic, VivaNeo, Copenhagen | UNKNOWN |
| Hvidovre Fertility Clinic, Copenhagen |
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A prospective cohort study in IVF patients at 5 IVF centres in Denmark. The primary aim is to include patients positive for abnormal vaginal microbiota to an RCT (EUDRACT 2016-002385-31). Secondary aims are the prevalence of abnormal vaginal microbiota in women undergoing IVF treatment, intimate hygiene and relations to the vaginal microbiota, basic fertility work up in relation to vaginal microbiota.
At the time of the interim stage of the RCT (EUDRACT 2016-002385-31), we plan to make a first cross-sectional investigation of the intimate hygiene questionnaire at baseline as compared to abnormal vaginal microbiota. We plan to make focused interview of N=30 patients to cover any additional female hygiene details not covered in the original questionnaire. After this investigation we may include new questions after the interim analysis - given that the study proceeds. In this case we plan to publish the first results of the intimate hygiene habits of the patients enrolled until interim stage.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| qPCR for abnormal vaginal microbiota | Diagnostic Test | qPCR for A.vaginae and/or G.vaginalis as developed in the pilot study (Hum Reprod. 2016 Apr;31(4):795-803. doi: 10.1093/humrep/dew026. Epub 2016 Feb 23.) |
| Measure | Description | Time Frame |
|---|---|---|
| Abnormal vaginal microbiota | qPCR positive diagnosis as described in intervention. | minimum 2-7 days from vaginal swab. |
| Measure | Description | Time Frame |
|---|---|---|
| Intimate hygiene | questionnaire | 2-5 weeks from baseline to embryo transfer |
| Male/partner seminal microbiome | DNA sequencing of seminal samples |
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Inclusion Criteria:
Exclusion Criteria:
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Infertile women fulfilling the abovementioned criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Peter Humaidan, Professor | The Fertility Clinic Skive | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fertility Clinic Skive, Skive Regional Hospital | Skive | 7800 | Denmark |
By Danish law, we cannot share individual data. But pseudomized data might be available from the National Danish archives. We aim to publish as fully as possible by Danish data protection law.
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| UNKNOWN |
| Køge Fertility Clinic, Denmark | UNKNOWN |
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Vaginal swabs
| 2-4 weeks from baseline to oocyte pick-up |
| Number of participants with Clinical pregnancy as measured by heartbeat | Tested by ultrasound scanning in week 7-9. | 7-9 weeks after inclusion. |
| Number of participants achieving Live birth (defined as birth of a living child later than 23 weeks) | Tested by self-reported schemes mailed to the clinics. | 36-42 weeks after inclusion |
| Cumulative live birth rate | The number of live births originating from one controlled ovarian stimulation. | 9 months - 24 months after inclusion |