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.
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.
Study Type
OBSERVATIONAL
Enrollment
120
Peking university third hospital
Beijing, Beijing Municipality, China
RECRUITINGClinical pregnancy rate
One or more observed gestational sac or definitive clinical signs of pregnancy under ultrasonography at 4 weeks after embryo transfer (including clinically documented ectopic pregnancy)
Time frame: 4 weeks after embryo transfer
Microbiota ratio
The ratio of microbiota within 3 groups will be acquired and analyzed by Metagenomics and 16SrRNA sequence. Shannon's diversity index and Chao richness will be used to measure the different ratio of microbiota within these 3 groups
Time frame: About 2 months later after samples collection
Oocyte retrieval
Number of oocytes retrieved for use in the following IVF-ET procedure will be counted under microscope
Time frame: 36 hours after HCG injection
Fertilization rate
Number of zygotes with 2 PN will be observed and counted under microscope
Time frame: 16-20 hours after oocyte retrieval
Available embryo
Number of embryos ≥4 cells and ≤30% fragmentation on day 3 observation will be observed and counted under microscope
Time frame: 72 hours after oocyte retrieval
Good quality embryo
Number of embryos with ≥6 cells and ≤30% fragmentation developed from 2PN embryos on day 3 observation
Time frame: 72 hours after oocyte retrieval
Endometrium thickness
Transvaginal Ultrasonography will be used to measure the endometrium thickness on the day of embryo transfer
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Time frame: On the day of embryo transfer
Implantation rate
Number of gestational sacs observed per embryo transferred will be observed under ultrasonography
Time frame: 30 days after embryo transfer
Ongoing pregnancy rate
Presence of a gestational sac and fetal heartbeat after 10 weeks of gestationwill be monitored by ultrasound
Time frame: 10 weeks after embryo transfer
Live birth rate
A delivery of one or more living infants (≥24 weeks gestation or birth weight more than 1,000g) will be followed up via telephone
Time frame: After 24 weeks of gestation