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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04293068
• Other study ID #: 2020Microbiota
• Status: Recruiting
• Start date: August 18, 2020
• Est. completion date: December 2021

Study information

• Verified date: January 2021
• Source: Peking University Third Hospital
• Contact: Fen-Ting Liu, Bachelor
• Phone: 15625120620
• Email: 624603036[@]qq.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2021
• Est. primary completion date: July 2021
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Abortion, Habitual
• Abortion, Spontaneous
• Infertility
• Recurrent Implantation Failure
• Recurrent Miscarriage

Locations

Country	Name	City	State
China	Peking university third hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Oocyte retrieval	Number of oocytes retrieved for use in the following IVF-ET procedure will be counted under microscope	36 hours after HCG injection
Secondary	Fertilization rate	Number of zygotes with 2 PN will be observed and counted under microscope	16-20 hours after oocyte retrieval
Secondary	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
Secondary	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
Secondary	Endometrium thickness	Transvaginal Ultrasonography will be used to measure the endometrium thickness on the day of embryo transfer	On the day of embryo transfer
Secondary	Implantation rate	Number of gestational sacs observed per embryo transferred will be observed under ultrasonography	30 days after embryo transfer
Secondary	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
Secondary	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