NCT04293068

Effect of Reproductive Tract Microbiota on Pregnancy Outcome in IVF/ICSI

Effect of Reproductive Tract Microbiota on Pregnancy Outcome in Patients Accepted In-vitro Fertilization/Intracytoplasmic Sperm Injection and Embryo Transfer

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: —

Summary

A single center，observational cohort study to explore the relationship between reproductive tract microbiota and pregnancy outcome in the patients accepted IVF/ICSI. To investigate whether there is a correlation between reproductive tract microbiota and IVF/ICSI outcomes. Whether there are differences in reproductive tract microbiota (such as vagina, follicular fluid, uterine cavity, etc.) in patients with different pregnancy outcomes.

Detailed description

A single center，observational cohort study will enroll 120 infertile participants and then divide them into 3 groups: 1)Male infertility；2)Recurrent implantation failure; 3)Recurrent spontaneous abortion. The study will last for 1 year and recruit participants in Reproductive medicine center of Peking university third hospital. Each participant will be followed up for at least 1 year. Collect samples and record information at the first month, then follow-up 2 months to record the pregnancy outcomes. DNA will be extracted from the samples and then have sequence to figure out the compositions of microbiota.

Conditions

• Infertility
• Recurrent Implantation Failure
• Recurrent Miscarriage

Timeline

• Start date: 2020-08-18
• Primary completion: 2021-07-01
• Completion: 2021-12-01
• First posted: 2020-03-03
• Last updated: 2021-02-02

Locations

1 site across 1 country: China