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Microbiome and Metabolome Profiles in Couples Undergoing IVF and Their Association With Reproductive Outcomes in a Prospective Longitudinal Cohort Study

Status: Recruiting
Location: See all (3) locations...
Study Type: Observational
SUMMARY

This prospective observational cohort study investigates the role of the microbiome and metabolome in couples undergoing in vitro fertilization. Biological samples will be collected from both female and male partners, including semen, vaginal, and blood samples, to characterize microbial composition and metabolic profiles. The study aims to examine how these biological profiles are associated with reproductive outcomes such as fertilization, pregnancy, miscarriage, and live birth. Participants will be followed longitudinally, and reproductive and obstetric outcomes will be obtained through linkage with national health registers.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 40
Healthy Volunteers: t
View:

• Women aged 18 to 40 years at enrolment.

• Men aged between 18 to 56 years at enrolment.

• Couples planning to undergo IVF treatment at a participating centre.

• Sufficient understanding of spoken and written Swedish or English to provide informed consent and complete the web-based questionnaire.

Locations
Other Locations
Sweden
Reproduktionsmottagning Malmö, Skånes universitetssjukhus
RECRUITING
Malmo
Karolinska Universitetssjukhuset
RECRUITING
Stockholm
Reproduktionscenter, Akademiska sjukuhset
RECRUITING
Uppsala
Contact Information
Primary
Ola Larsson, PhD
ola.larsson@ki.se
+46 8 524 80000
Backup
Hanna Nilsson, PhD
hanna.nilsson@ki.se
Time Frame
Start Date: 2022-06-10
Estimated Completion Date: 2029-03-01
Participants
Target number of participants: 1000
Treatments
Couples Undergoing IVF Treatment
Prospective cohort of couples undergoing in vitro fertilization (IVF) treatment at participating in a multicenter fertility clinics in Sweden. Biological samples are collected from both partners for microbiome and metabolome profiling, and participants are followed longitudinally for reproductive and obstetric outcomes through linkage with national health registers.
Related Therapeutic Areas
Sponsors
Leads: Karolinska Institutet

This content was sourced from clinicaltrials.gov