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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Related tests were normal, because the male factor alone required the first IVF/ICSI cycle; Follow-up of included patients was conducted to determine whether embryo transplantation was performed, and the score of transferred embryos was recorded, and the final control group would be confirmed after achieving clinical pregnancy | ||
| Recurrent implantation failure | Previous ≥3 consecutive embryo transfer failures | ||
| Recurrent spontaneous abortion(miscarriage) | ≥2 consecutive spontaneous abortions or embryo damage |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical 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) | 4 weeks after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | About 2 months later after samples collection |
| Oocyte retrieval |
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Inclusion Criteria:
Exclusion Criteria:
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The recruited participants conformed to the eligibility criteria will be divided into 3 groups (Control group: male infertility; RIF group; RM group). Each group will be recruited at least 30 cases.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fen-Ting Liu, Bachelor | Contact | 15625120620 | 624603036@qq.com | |
| Shuo Yang, M.D. | Contact | 13810349928 | yangshuo@263.net |
| Name | Affiliation | Role |
|---|---|---|
| Rong Li, M.D. | Peking University Third Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking university third hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D000026 | Abortion, Habitual |
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Number of oocytes retrieved for use in the following IVF-ET procedure will be counted under microscope |
| 36 hours after HCG injection |
| Fertilization rate | Number of zygotes with 2 PN will be observed and counted under microscope | 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 | 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 | 72 hours after oocyte retrieval |
| Endometrium thickness | Transvaginal Ultrasonography will be used to measure the endometrium thickness on the day of embryo transfer | On the day of embryo transfer |
| Implantation rate | Number of gestational sacs observed per embryo transferred will be observed under ultrasonography | 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 | 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 | After 24 weeks of gestation |