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.
Study Type
OBSERVATIONAL
Enrollment
1,850
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.)
Fertility Clinic Skive, Skive Regional Hospital
Skive, Denmark
Abnormal vaginal microbiota
qPCR positive diagnosis as described in intervention.
Time frame: minimum 2-7 days from vaginal swab.
Intimate hygiene
questionnaire
Time frame: 2-5 weeks from baseline to embryo transfer
Male/partner seminal microbiome
DNA sequencing of seminal samples
Time frame: 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.
Time frame: 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.
Time frame: 36-42 weeks after inclusion
Cumulative live birth rate
The number of live births originating from one controlled ovarian stimulation.
Time frame: 9 months - 24 months after inclusion
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