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

December 21, 2019 updated by: Yanhong Deng, Sun Yat-sen University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

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

Study Contact Backup

  • Name: Xing Yang, M.D. & Ph.D
  • Phone Number: 020-38048010

Study Locations

  • China
      • Guandong, China
        • Recruiting
        • The Sixth Affiliated Hospital,Sun Yat-Sen University

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Infertile patients who had live birth previously and met the criteria, required for IVF treatment from Aug 2019 to Aug 2022 in our center.

Description

Inclusion Criteria:

  1. Women age ≥20 years and ≤40 years.
  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:

  1. surgery history including: Ovariectomy, myomectomy, adenomyomectomy.
  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.).

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Natural labour group
Other: 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 Names:
  • assisted reproductive medicine
Cesarean scar group
Other: 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 Names:
  • assisted reproductive medicine
Cesarean with diverticulum (PCSD) group
Other: 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 Names:
  • assisted reproductive medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Species and communities of uterine microflora
Time Frame: 1-2 year
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
Time Frame: 1-2 year
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
Time Frame: 1-2 year

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
Time Frame: 1-2 year
Biochemical pregnancy rate(%): number of biochemical pregnancy/transferred cycle.
1-2 year
Embryo implantation rate
Time Frame: 1-2 year
Embryo implantation rate(%): number of gestational sac / transferred embryo.
1-2 year
Live birth rate
Time Frame: 1-2 year
Live birth rate(%): number of live birth/ transferred cycle.
1-2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Study Chair: Xing Yang, M.D. & Ph.D, The Sixth Affiliated Hospital,Sun Yat-Sen University
  • Study Director: Xaoyan Liang, M.D. & Ph.D, The Sixth Affiliated Hospital,Sun Yat-Sen University

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 1, 2019

Primary Completion (Anticipated)

August 1, 2022

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

August 26, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Actual)

December 24, 2019

Last Update Submitted That Met QC Criteria

December 21, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • newivf20190807

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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