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van CCT (UK)


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Subfertility and chronic inflammation


- candidate number22467
- NTR NumberNTR5393
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jul-2015
- Secondary IDs 
- Public TitleSubfertility and chronic inflammation
- Scientific TitleCytokines,vaginal microbiome and subfertility. A pilotstudy
- ACRONYMbarew
- hypothesisHypothesis: Subfertility is influenced by (low) chronic inflammation. Cytokine and microbiome profiling can be substantial in detecting the state of chronic inflammation and may thus help in solving subfertility.
- Healt Condition(s) or Problem(s) studiedFertility
- Inclusion criteriawomen with idiopathatic subfertility for a duration of 3 years and more (N=20)
lesbian couple and single mothers seeking to fulfill their childwish, with negative histories of cycle irregularity, STD's,, abdominal surgery. (N=20)
- Exclusion criteria1. free of fever during the past month prior to study entry
2. free of antimicrobial interventions during the past month of study entry
3. positive CAT IgG sampling
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-okt-2015
- planned closingdate10-okt-2016
- Target number of participants40
- Interventionsnone
Research subjects are treated with IUI (IntraUterine Insemination). After informed consent one time bloodsampling + one vaginal swab will be taken for determinations of respectively cytokines and microbiome profiling.
- Primary outcomeassociation between cytokine profile and subfertility
association between vaginal microbiome and subfertility
are cytokine profiles related to vaginal microbiome patterns?
- Secondary outcomeStatisitical model to predict which patient variables can be used to quantify the prognosis of subfertility.
- TimepointsRecruitment will end April 2016.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr J.P.W. Vermeiden
- CONTACT for SCIENTIFIC QUERIESDr J.P.W. Vermeiden
- Sponsor/Initiator Fertility Center Nij Barrahūs
- Funding
(Source(s) of Monetary or Material Support)
Fertility Center Nij Barrahūs
- Publications
- Brief summaryIn 20 normal fertile and 20 subfertile women visiting Nij Barrahus, fertility center a bloodsample and a vaginal swab will be taken at one specific moment in their treatment cycle (moment of IUI, scheduled 24-30H after a spontaneous LH surge).
Does cytokine and/or vaginal microbiome determinations reflect a specific profile, which can be attributed to a (low) chronic state of inflammation and therefore to a changed innate immune system?
- Main changes (audit trail)
- RECORD15-jul-2015 - 17-okt-2015


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