Идёт набор NCT07532629

Microbiome and Metabolome Profiles in Couples Undergoing IVF and Reproductive Outcomes

— Наблюдательное Infertility Assisted Reproductive Technology Pregnancy Complications Pregnancy Loss, Early

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Infertility, Assisted Reproductive Technology, Pregnancy Complications, Pregnancy Loss, Early. Базовые параметры: 18 лет — 40 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швеция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

Infertility affects a substantial proportion of couples worldwide, and in vitro fertilization (IVF) is an important treatment option for many individuals experiencing infertility. Increasing evidence suggests that the human microbiome and metabolome may play a role in reproductive health and fertility outcomes. However, the contribution of microbial communities and metabolic profiles in both female and male partners to IVF outcomes remains insufficiently understood.

This prospective observational cohort study aims to investigate the microbiome and metabolome profiles in couples undergoing IVF treatment and their association with reproductive and obstetric outcomes. Heterosexual couples undergoing IVF treatment at participating fertility clinics will be recruited. Biological samples will be collected from both partners, including semen samples from male partners and vaginal and blood samples from female partners. These samples will be stored and analyzed using sequencing-based microbiome profiling and metabolomic analyses.

The study will evaluate microbial composition, diversity, and metabolic signatures in relation to fertility parameters such as semen quality, fertilization rate, embryo development, and clinical pregnancy. Participants will be followed longitudinally to assess reproductive outcomes including miscarriage, preterm birth, preeclampsia, and live birth. Outcome data will be obtained through clinical records and linkage with national health registers.

The overall aim of the study is to improve the understanding of how microbiome and metabolome profiles in both partners may influence reproductive success and pregnancy outcomes in couples undergoing IVF.

Первичные конечные точки

Number of Participants with Live Birth [Срок оценки: Through delivery, up to 12 months after embryo transfer]

Вторичные конечные точки (12)

Number of Participants With Miscarriage Before 22 Weeks of Gestation [Срок оценки: Up to 21 weeks and 6 days of gestation]
Number of Participants With Preterm Birth Before 37 Completed Weeks of Gestation [Срок оценки: At delivery]
Number of Participants With Preeclampsia [Срок оценки: During pregnancy through 6 weeks postpartum]
Relative Abundance of Prespecified Microbial Taxa in Female Reproductive Tract Samples [Срок оценки: Time Frame: Baseline (Day 0, prior to initiation of IVF stimulation); early pregnancy confirmation visit (gestational weeks 7 to 9); and at miscarriage, if applicable, during pregnancy up to gestational age 21 weeks 6 days]
Concentration of Prespecified Metabolites in Female Reproductive Tract Samples [Срок оценки: Baseline, prior to initiation of IVF treatment]
Number of Participants With Clinical Pregnancy Confirmed by Ultrasound [Срок оценки: 6 to 8 weeks after embryo transfer]
Number of Participants With Biochemical Pregnancy [Срок оценки: 10 to14 days after embryo transfer]
Sperm concentration [Срок оценки: At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation]
Relative Abundance of Prespecified Microbial Taxa in Seminal Fluid Samples [Срок оценки: At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation]
Concentration of Prespecified Metabolites in Male Semen Samples [Срок оценки: At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation]
Fertilization Rate per Retrieved Mature Oocyte [Срок оценки: Day 1 after oocyte retrieval]
Normal sperm morphology [Срок оценки: At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation]

Критерии участия

Критерии включения

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.