Couples and Microbial Diversity
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorTampere University Hospital
About this trial
Couples and Microbial Diversity (CLARITY) - study is a prospective study that investigates the risks and dynamics of different microbes and transmission among couples to optimize the prevention and control strategies as well as improvement for infertility treatments.
The study will be conducted at the Infertility Clinic of Tampere University Hospital, Tampere Finland; and will recruit 200 couples undergoing infertility investigations and treatments. Oral and genital tract samples will be collected at baseline and every six months during a two-year follow-up period. Background information will be obtained through a secure online questionnaire.
Couples who achieve pregnancy will be followed according to the CLARITY protocol until delivery, after which families will transition to the CLARITY-Baby extension study. Samples from both the newborn and parents will be collected at delivery and again at six months postpartum, accompanied by an online follow-up questionnaire completed by the parents.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Problems in conceiving the past 12 months
Over 18 years old
Fluent in Finnish
Disqualifiers
Needs for donated gametes (except for female homosexual couples)
Trial population
Couples attending the Tampere University Hospital (TAUH) infertility clinic due to problems in conceiving during the past 12 months.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: CLARITY
Trial outcomes
Primary outcomes
1
Risks and dynamics of different microbes and transmission among infertile couples
Oral and genital samples are sequenced for various microbes with metagenomic sequencing to detect various viral, bacterial and mycobiome infections
Time frame
From enrolment to 24 month follow-up samplesLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: