Microbiome and Metabolome Profiles in Couples Undergoing IVF and Their Association With Reproductive Outcomes in a Prospective Longitudinal Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- Number of Participants with Live Birth
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Pregnancy at the time of enrolment (confirmed or suspected).
- •Recent systemic antibiotic use within the past 4 weeks
- •Active vaginal or genital tract infection at the time of sampling
研究组 & 干预措施
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.
结局指标
主要结局
Number of Participants with Live Birth
时间窗: Through delivery, up to 12 months after embryo transfer
Delivery of a live-born infant after IVF treatment, identified through linkage with national health registers.
次要结局
- Number of Participants With Miscarriage Before 22 Weeks of Gestation(Up to 21 weeks and 6 days of gestation)
- Number of Participants With Preterm Birth Before 37 Completed Weeks of Gestation(At delivery)
- Number of Participants With Preeclampsia(During pregnancy through 6 weeks postpartum)
- Relative Abundance of Prespecified Microbial Taxa in Female Reproductive Tract Samples(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(Baseline, prior to initiation of IVF treatment)
- Number of Participants With Clinical Pregnancy Confirmed by Ultrasound(6 to 8 weeks after embryo transfer)
- Number of Participants With Biochemical Pregnancy(10 to14 days after embryo transfer)
- Sperm concentration(At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation)
- Relative Abundance of Prespecified Microbial Taxa in Seminal Fluid Samples(At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation)
- Concentration of Prespecified Metabolites in Male Semen Samples(At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation)
- Fertilization Rate per Retrieved Mature Oocyte(Day 1 after oocyte retrieval)
- Normal sperm morphology(At oocyte retrieval, approximately 10 to 20 days after initiation of IVF stimulation)
- Levels of Immune Markers in Female Blood Samples(Baseline (Day 0), prior to initiation of IVF stimulation)
研究者
Kenny Rodriguez-Wallberg
MD., Professor
Karolinska Institutet