Infertility, Recurrent Implantation Failure, Recurrent Miscarriage
Conditions
Keywords
Infertility, Recurrent implantation failure, Recurrent spontaneous abortion, Reproductive tract microbiota, In vitro fertilization
Brief 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.
Interventions
None listed
Sponsors
Peking University Third Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Inclusion criteria
1. The sampling cycle of all samples requires no use of glucocorticoids, antibiotics and vaginal drugs within the cycle of this month; No cervical treatment within a week; No irrigation, asexual life within 5 days; Strict contraception in this month; 2. Male infertility (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) OR Recurrent implantation failure (Previous ≥3 consecutive embryo transfer failures) OR Recurrent spontaneous abortion (≥2 consecutive spontaneous abortions or embryo damage)
Exclusion criteria
1. Acute genital tract inflammation (including vagina, cervix, endometrium and pelvic cavity) 2. Previous diagnosis of intrauterine adhesion or mechanical damage to the endometrium; drugs and surgery can not restore the function (endometrium thickness \<7mm in the window period before transplantation) 3. Untreated hydrosalpinx, submucosal or \>4cm intramuscular uterine fibroids, adenomyosis, stage III-IV endometriosis confirmed by surgery, endometritis diagnosed by pathology and other definite factors might affect implantation 4. Chromosomal abnormalities in couples may lead to miscarriage, fetal malformation and other diseases 5. Previous examination indicated the existence of DOR (FSH≥9U/L and/or AMH ≤1.1ng/ml and/or AFC≤5-7) 6. Those with polycystic ovary syndrome, high prolactinemia and other ovulation disorders 7. Those with congenital adrenal hyperplasia, hypothyroidism/hyperthyroidism, diabetes, metabolic syndrome and other endocrine and metabolic diseases 8. BMI less than 18 or more than 25 9. Previous autoimmune diseases such as anti-heart coagulation syndrome, sjogren's syndrome and rheumatoid arthritis 10. Prethrombotic hypercoagulability or family history of thrombosis 11. Female genital tract deformities (whether or not surgically corrected) 12. Those within the programme of oocyte or sperm donor 13. Those with previous history of various types of cancer or serious systemic diseases (such as heart, lung and blood diseases) or mental diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy rate | 4 weeks after embryo transfer | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oocyte retrieval | 36 hours after HCG injection | Number of oocytes retrieved for use in the following IVF-ET procedure will be counted under microscope |
| Fertilization rate | 16-20 hours after oocyte retrieval | Number of zygotes with 2 PN will be observed and counted under microscope |
| Available embryo | 72 hours after oocyte retrieval | Number of embryos ≥4 cells and ≤30% fragmentation on day 3 observation will be observed and counted under microscope |
| Good quality embryo | 72 hours after oocyte retrieval | Number of embryos with ≥6 cells and ≤30% fragmentation developed from 2PN embryos on day 3 observation |
| Microbiota ratio | About 2 months later after samples collection | 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 |
| Implantation rate | 30 days after embryo transfer | Number of gestational sacs observed per embryo transferred will be observed under ultrasonography |
| Ongoing pregnancy rate | 10 weeks after embryo transfer | Presence of a gestational sac and fetal heartbeat after 10 weeks of gestationwill be monitored by ultrasound |
| Live birth rate | After 24 weeks of gestation | A delivery of one or more living infants (≥24 weeks gestation or birth weight more than 1,000g) will be followed up via telephone |
| Endometrium thickness | On the day of embryo transfer | Transvaginal Ultrasonography will be used to measure the endometrium thickness on the day of embryo transfer |
Countries
China
Contacts
Primary ContactFen-Ting Liu, Bachelor
Backup ContactShuo Yang, M.D.
Outcome results
None listed