The Outcome and Influence Factors of Assisted Reproductive Therapy in Patients With Cesarean Scar Uterus.
NCT ID: NCT04070222
Last Updated: 2019-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
120 participants
OBSERVATIONAL
2019-08-01
2023-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Though Cesarean section plays an important role in the treatment of dystocia and also decreasing perinatal mortality, it may impact natural conception and the success rate of ART in secondary infertile patients. Data from other researchers have revealed that Cesarean scar may related to poor pregnancy outcome during ART treatment. We have retrospectively analyzed the pregnancy outcome of ART treatment in patients who have had live birth previously from January 2014 to May 2018. The biochemical pregnancy rate, embryo implantation rate and clinical pregnancy rate are all lower in patients with Caesarean section compared to patients after natural labour, the clinical data is even worse in patients with PCSD. The results suggest a close correlation between the outcome of assisted reproductive therapy and the uterine condition. Further evaluations are required related to whether the dominate endometrial microflora is interrupted by the Cesarean section in the infertile women undergoing ART, and the potential mechanism will also be explored accordingly. A single-center, prospective, case-control study will be carried out.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Natural labour group
Hysteroscopy
1. Three groups of patients will be enrolled: Natural labour group, Cesarean scar group and Cesarean with diverticulum (PCSD) group;
2. Hysteroscopy will be carried out for uterine cavity examine and the specimen collection for further microflora analysis and inflammation marker detection;
3. ART will be carried out with standard protocol and the clinical outcome will be recorded;
4. The primary outcome of the study is the comparation of species and communities of uterine microflora and inflammatory markers of the female uterus among three groups. The secondary outcome is biochemical pregnancy rate, clinical pregnancy rate, embryo implantation rate and live birth rate.
Cesarean scar group
Hysteroscopy
1. Three groups of patients will be enrolled: Natural labour group, Cesarean scar group and Cesarean with diverticulum (PCSD) group;
2. Hysteroscopy will be carried out for uterine cavity examine and the specimen collection for further microflora analysis and inflammation marker detection;
3. ART will be carried out with standard protocol and the clinical outcome will be recorded;
4. The primary outcome of the study is the comparation of species and communities of uterine microflora and inflammatory markers of the female uterus among three groups. The secondary outcome is biochemical pregnancy rate, clinical pregnancy rate, embryo implantation rate and live birth rate.
Cesarean with diverticulum (PCSD) group
Hysteroscopy
1. Three groups of patients will be enrolled: Natural labour group, Cesarean scar group and Cesarean with diverticulum (PCSD) group;
2. Hysteroscopy will be carried out for uterine cavity examine and the specimen collection for further microflora analysis and inflammation marker detection;
3. ART will be carried out with standard protocol and the clinical outcome will be recorded;
4. The primary outcome of the study is the comparation of species and communities of uterine microflora and inflammatory markers of the female uterus among three groups. The secondary outcome is biochemical pregnancy rate, clinical pregnancy rate, embryo implantation rate and live birth rate.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hysteroscopy
1. Three groups of patients will be enrolled: Natural labour group, Cesarean scar group and Cesarean with diverticulum (PCSD) group;
2. Hysteroscopy will be carried out for uterine cavity examine and the specimen collection for further microflora analysis and inflammation marker detection;
3. ART will be carried out with standard protocol and the clinical outcome will be recorded;
4. The primary outcome of the study is the comparation of species and communities of uterine microflora and inflammatory markers of the female uterus among three groups. The secondary outcome is biochemical pregnancy rate, clinical pregnancy rate, embryo implantation rate and live birth rate.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. infertile Women with previously live birth.
3. Previous failed transfer cycle ≤2
4. Didn't participate in other clinical subjects within three months.
5. Written informed consent.
Exclusion Criteria
2. Uterine diseases including: uterine malformation, submucosal uterine fibroids and intrauterine adhesion.
3. One of couple has abnormal karyotype.
4. Recurrent abortion ≥2.
5. Untreated hydrosalpinx.
6. History of tuberculosis (pulmonary tuberculosis, pelvic tuberculosis etc.).
20 Years
40 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Yat-sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yanhong Deng
MD
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xing Yang, M.D. & Ph.D
Role: STUDY_CHAIR
The Sixth Affiliated Hospital, Sun Yat-sen University
Xaoyan Liang, M.D. & Ph.D
Role: STUDY_DIRECTOR
The Sixth Affiliated Hospital, Sun Yat-sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Sixth Affiliated Hospital,Sun Yat-Sen University
Guandong, , China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Xing Yang, M.D. & Ph.D
Role: CONTACT
Phone: 020-38048010
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
newivf20190807
Identifier Type: -
Identifier Source: org_study_id