Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
Study NCT ID:
NCT04293068
Status:
UNKNOWN
Last Update Posted:
2021-02-02
First Post:
2020-02-27
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Reproductive Tract Microbiota on Pregnancy Outcome in IVF/ICSI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}, {'id': 'D000026', 'term': 'Abortion, Habitual'}, {'id': 'D000022', 'term': 'Abortion, Spontaneous'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-30', 'studyFirstSubmitDate': '2020-02-27', 'studyFirstSubmitQcDate': '2020-03-02', 'lastUpdatePostDateStruct': {'date': '2021-02-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '4 weeks after embryo transfer', 'description': '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)'}], 'secondaryOutcomes': [{'measure': 'Microbiota ratio', 'timeFrame': 'About 2 months later after samples collection', 'description': "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"}, {'measure': 'Oocyte retrieval', 'timeFrame': '36 hours after HCG injection', 'description': 'Number of oocytes retrieved for use in the following IVF-ET procedure will be counted under microscope'}, {'measure': 'Fertilization rate', 'timeFrame': '16-20 hours after oocyte retrieval', 'description': 'Number of zygotes with 2 PN will be observed and counted under microscope'}, {'measure': 'Available embryo', 'timeFrame': '72 hours after oocyte retrieval', 'description': 'Number of embryos ≥4 cells and ≤30% fragmentation on day 3 observation will be observed and counted under microscope'}, {'measure': 'Good quality embryo', 'timeFrame': '72 hours after oocyte retrieval', 'description': 'Number of embryos with ≥6 cells and ≤30% fragmentation developed from 2PN embryos on day 3 observation'}, {'measure': 'Endometrium thickness', 'timeFrame': 'On the day of embryo transfer', 'description': 'Transvaginal Ultrasonography will be used to measure the endometrium thickness on the day of embryo transfer'}, {'measure': 'Implantation rate', 'timeFrame': '30 days after embryo transfer', 'description': 'Number of gestational sacs observed per embryo transferred will be observed under ultrasonography'}, {'measure': 'Ongoing pregnancy rate', 'timeFrame': '10 weeks after embryo transfer', 'description': 'Presence of a gestational sac and fetal heartbeat after 10 weeks of gestationwill be monitored by ultrasound'}, {'measure': 'Live birth rate', 'timeFrame': 'After 24 weeks of gestation', 'description': 'A delivery of one or more living infants (≥24 weeks gestation or birth weight more than 1,000g) will be followed up via telephone'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Infertility', 'Recurrent implantation failure', 'Recurrent spontaneous abortion', 'Reproductive tract microbiota', 'In vitro fertilization'], 'conditions': ['Infertility', 'Recurrent Implantation Failure', 'Recurrent Miscarriage']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': "Inclusion Criteria:\n\n1. 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;\n2. 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)\n\nExclusion Criteria:\n\n1. Acute genital tract inflammation (including vagina, cervix, endometrium and pelvic cavity)\n2. 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)\n3. 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\n4. Chromosomal abnormalities in couples may lead to miscarriage, fetal malformation and other diseases\n5. Previous examination indicated the existence of DOR (FSH≥9U/L and/or AMH ≤1.1ng/ml and/or AFC≤5-7)\n6. Those with polycystic ovary syndrome, high prolactinemia and other ovulation disorders\n7. Those with congenital adrenal hyperplasia, hypothyroidism/hyperthyroidism, diabetes, metabolic syndrome and other endocrine and metabolic diseases\n8. BMI less than 18 or more than 25\n9. Previous autoimmune diseases such as anti-heart coagulation syndrome, sjogren's syndrome and rheumatoid arthritis\n10. Prethrombotic hypercoagulability or family history of thrombosis\n11. Female genital tract deformities (whether or not surgically corrected)\n12. Those within the programme of oocyte or sperm donor\n13. Those with previous history of various types of cancer or serious systemic diseases (such as heart, lung and blood diseases) or mental diseases"}, 'identificationModule': {'nctId': 'NCT04293068', 'briefTitle': 'Effect of Reproductive Tract Microbiota on Pregnancy Outcome in IVF/ICSI', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Effect of Reproductive Tract Microbiota on Pregnancy Outcome in Patients Accepted In-vitro Fertilization/Intracytoplasmic Sperm Injection and Embryo Transfer', 'orgStudyIdInfo': {'id': '2020Microbiota'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control group', 'description': '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'}, {'label': 'Recurrent implantation failure', 'description': 'Previous ≥3 consecutive embryo transfer failures'}, {'label': 'Recurrent spontaneous abortion(miscarriage)', 'description': '≥2 consecutive spontaneous abortions or embryo damage'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Rong Li, MD，PHD', 'role': 'CONTACT', 'email': 'roseli001@sina.com', 'phone': '13701085402'}], 'facility': 'Peking university third hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Fen-Ting Liu, Bachelor', 'role': 'CONTACT', 'email': '624603036@qq.com', 'phone': '15625120620'}, {'name': 'Shuo Yang, M.D.', 'role': 'CONTACT', 'email': 'yangshuo@263.net', 'phone': '13810349928'}], 'overallOfficials': [{'name': 'Rong Li, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Reproductive Medical Center', 'investigatorFullName': 'Li Rong', 'investigatorAffiliation': 'Peking University Third Hospital'}}}}