Couples and Microbial Diversity

NCT07315568 | Not Yet Recruiting

• 1 other identifier: R23082
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Infertility; Transmission; Infections

Keywords

Human Microbiome; HPV; Infertility; Microbial Diversity

Outcome Measures

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

  From enrolment to 24 month follow-up samples

Study Arms (1)

CLARITY

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Problems in conceiving the past 12 months
• Over 18 years old
• Fluent in Finnish

You may not qualify if:

• Needs for donated gametes (except for female homosexual couples)

Sponsors & Collaborators

• Tampere University Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

We will take swab samples from the cervix/vagina/anus (women), additionally penile shaft (men) as well as saliva samples and gargle samples from oral cavity from all participating. The follow-up samples are self-collected samples: saliva, oral gargle, genital sample. At birth additional sample from the placenta and breast milk are collected. From the offspring the oral, genital and anus samples are collected at the hospital and at home at six months anus ja oral sample.

MeSH Terms

Conditions

Infertility; Infections

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Karolina Louvanto, Professor

  Tampere University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karolina Louvanto, Professor

CONTACT

+358504713838; karolina.louvanto@tuni.fi

Marianne Kamaja, MD

CONTACT

marianne@fimnet.fi

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 30, 2031
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 3 months after publication with no end date
• Access Criteria: IPD that underlie the results reported in a publication, after de-identification, will be available for researchers who provide a methodologically sound proposal with achievable aims. Proposals should be directed via e-mail to the PI of the study (KL); data requestors will need to sign a data access agreement.