The Outcome and Influence Factors of Assisted Reproductive Therapy in Patients With Cesarean Scar Uterus.

Study Overview
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Brief Summary
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Mode of delivery affects the success rate of assisted reproductive techniques (ART). In this case study, the investigators will evaluate changes in the bacterial ecology and inflammatory markers of the female uterus with different delivery modes. We will investigate whether the dominate endometrial microflora is interrupted by the Cesarean section in the infertile women undergoing ART, and the potential mechanism will also be further explored prospectively.

Detailed Description
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The highly prevalence of cesarean section rate in China had drawn great attention world widely. Post-cesarean section scar diverticulum ( PCSD) is a poor healing of the local incision after Cesarean section which happened in19.4% 88% of patients. The cavity is formed by the original incision connected with the uterine cavity. Patients with diverticulum are often accompanied by prolonged menstruation and uterine effusion, which may accompany with endometrial inflammation and impair embryo implantation rate. 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.

Official Title
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A Prospective Case-control Study of the Outcome and Influence Factors of Assisted Reproductive Therapy in Patients With Cesarean Scar Uterus.

Conditions
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Infertile Patients With Previous Live Birth

Intervention / Treatment
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* Other: Hysteroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women age ≥20 years and ≤40 years. infertile Women with previously live birth. Previous failed transfer cycle ≤2 Didn't participate in other clinical subjects within three months. Written informed consent. Exclusion Criteria: surgery history including: Ovariectomy, myomectomy, adenomyomectomy. Uterine diseases including: uterine malformation, submucosal uterine fibroids and intrauterine adhesion. One of couple has abnormal karyotype. Recurrent abortion ≥2. Untreated hydrosalpinx. History of tuberculosis (pulmonary tuberculosis, pelvic tuberculosis etc.).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Natural labour group<br> | Other: Hysteroscopy<br>* Three groups of patients will be enrolled: Natural labour group, Cesarean scar group and Cesarean with diverticulum (PCSD) group; Hysteroscopy will be carried out for uterine cavity examine and the specimen collection for further microflora analysis and inflammation marker detection; ART will be carried out with standard protocol and the clinical outcome will be recorded; 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.<br>* Other names: assisted reproductive medicine;|
| Cesarean scar group<br> | Other: Hysteroscopy<br>* Three groups of patients will be enrolled: Natural labour group, Cesarean scar group and Cesarean with diverticulum (PCSD) group; Hysteroscopy will be carried out for uterine cavity examine and the specimen collection for further microflora analysis and inflammation marker detection; ART will be carried out with standard protocol and the clinical outcome will be recorded; 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.<br>* Other names: assisted reproductive medicine;|
| Cesarean with diverticulum (PCSD) group<br> | Other: Hysteroscopy<br>* Three groups of patients will be enrolled: Natural labour group, Cesarean scar group and Cesarean with diverticulum (PCSD) group; Hysteroscopy will be carried out for uterine cavity examine and the specimen collection for further microflora analysis and inflammation marker detection; ART will be carried out with standard protocol and the clinical outcome will be recorded; 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.<br>* Other names: assisted reproductive medicine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Species and communities of uterine microflora | Use the swab to scrape endometrium. Characterization of species and communities of uterine microflora will use bacterial DNA microarray analysis. Normally, the uterine cavity used to being thought a sterile space. | 1-2 year | 
| Inflammatory markers of the female uterus | Use the swab to scrape endometrium. Characterization of inflammatory markers of the female uterus will use human cytokines measuring. The cytokines will include IL2,IL4,SDF-1α , etc. Use the natural labor group as control group, and see differentiation among the three group. | 1-2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate | Clinical pregnancy means pregnancy sac is seen intrauterine under ultrasound 7 weeks after embryo transferred. Clinical pregnancy rate(%): number of clinical pregnancy/transferred cycle. | 1-2 year | 
| Biochemical pregnancy rate | Biochemical pregnancy rate(%): number of biochemical pregnancy/transferred cycle. | 1-2 year | 
| Embryo implantation rate | Embryo implantation rate(%): number of gestational sac / transferred embryo. | 1-2 year | 
| Live birth rate | Live birth rate(%): number of live birth/ transferred cycle. | 1-2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Secondary infertility, cesarean section, post-cesarean section scar diverticulum , endometrial microflora, inflammatory markers, clinical pregnancy, live birth