Couples and Microbial Diversity

Sponsor
Tampere University Hospital
Study ID
NCT07315568
Status
Not Yet Recruiting

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Conditions

  • Infections
  • Infertility
  • Transmission

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jan 2, 2026
Start date
Jan 5, 2026
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Dec 30, 2031

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: CLARITY
    Couples attending the Tampere University Hospital (TAUH) infertility clinic due to problems in conceiving during the past 12 months.

Primary Outcome Measure

Risks and dynamics of different microbes and transmission among infertile couples [ Time Frame: From enrolment to 24 month follow-up samples ]

Central Contacts

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