- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04293068
Effect of Reproductive Tract Microbiota on Pregnancy Outcome in IVF/ICSI
January 30, 2021 updated by: Li Rong, Peking University Third Hospital
Effect of Reproductive Tract Microbiota on Pregnancy Outcome in Patients Accepted In-vitro Fertilization/Intracytoplasmic Sperm Injection and Embryo Transfer
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.
Study Overview
Status
Unknown
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.
Study Type
Observational
Enrollment (Anticipated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fen-Ting Liu, Bachelor
- Phone Number: 15625120620
- Email: 624603036@qq.com
Study Contact Backup
- Name: Shuo Yang, M.D.
- Phone Number: 13810349928
- Email: yangshuo@263.net
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100191
- Recruiting
- Peking University Third Hospital
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
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.
Description
Inclusion Criteria:
- 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;
- 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:
- Acute genital tract inflammation (including vagina, cervix, endometrium and pelvic cavity)
- 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)
- 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
- Chromosomal abnormalities in couples may lead to miscarriage, fetal malformation and other diseases
- Previous examination indicated the existence of DOR (FSH≥9U/L and/or AMH ≤1.1ng/ml and/or AFC≤5-7)
- Those with polycystic ovary syndrome, high prolactinemia and other ovulation disorders
- Those with congenital adrenal hyperplasia, hypothyroidism/hyperthyroidism, diabetes, metabolic syndrome and other endocrine and metabolic diseases
- BMI less than 18 or more than 25
- Previous autoimmune diseases such as anti-heart coagulation syndrome, sjogren's syndrome and rheumatoid arthritis
- Prethrombotic hypercoagulability or family history of thrombosis
- Female genital tract deformities (whether or not surgically corrected)
- Those within the programme of oocyte or sperm donor
- Those with previous history of various types of cancer or serious systemic diseases (such as heart, lung and blood diseases) or mental diseases
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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Recurrent spontaneous abortion(miscarriage)
≥2 consecutive spontaneous abortions or embryo damage
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical pregnancy rate
Time Frame: 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)
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4 weeks after embryo transfer
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microbiota ratio
Time Frame: About 2 months later after samples collection
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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
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About 2 months later after samples collection
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Oocyte retrieval
Time Frame: 36 hours after HCG injection
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Number of oocytes retrieved for use in the following IVF-ET procedure will be counted under microscope
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36 hours after HCG injection
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Fertilization rate
Time Frame: 16-20 hours after oocyte retrieval
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Number of zygotes with 2 PN will be observed and counted under microscope
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16-20 hours after oocyte retrieval
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Available embryo
Time Frame: 72 hours after oocyte retrieval
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Number of embryos ≥4 cells and ≤30% fragmentation on day 3 observation will be observed and counted under microscope
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72 hours after oocyte retrieval
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Good quality embryo
Time Frame: 72 hours after oocyte retrieval
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Number of embryos with ≥6 cells and ≤30% fragmentation developed from 2PN embryos on day 3 observation
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72 hours after oocyte retrieval
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Endometrium thickness
Time Frame: On the day of embryo transfer
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Transvaginal Ultrasonography will be used to measure the endometrium thickness on the day of embryo transfer
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On the day of embryo transfer
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Implantation rate
Time Frame: 30 days after embryo transfer
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Number of gestational sacs observed per embryo transferred will be observed under ultrasonography
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30 days after embryo transfer
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Ongoing pregnancy rate
Time Frame: 10 weeks after embryo transfer
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Presence of a gestational sac and fetal heartbeat after 10 weeks of gestationwill be monitored by ultrasound
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10 weeks after embryo transfer
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Live birth rate
Time Frame: After 24 weeks of gestation
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Rong Li, M.D., Peking University Third Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 18, 2020
Primary Completion (Anticipated)
July 1, 2021
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
February 27, 2020
First Submitted That Met QC Criteria
March 2, 2020
First Posted (Actual)
March 3, 2020
Study Record Updates
Last Update Posted (Actual)
February 2, 2021
Last Update Submitted That Met QC Criteria
January 30, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020Microbiota
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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