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

NCT04070222 | Unknown DMC

• 1 other identifier: newivf20190807
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertile Patients With Previous Live Birth

Keywords

Secondary infertility, cesarean section, post-cesarean section scar diverticulum , endometrial microflora, inflammatory markers, clinical pregnancy, live birth

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Clinical pregnancy rate

  1-2 year

• Biochemical pregnancy rate

  1-2 year

• Embryo implantation rate

  1-2 year

• Live birth rate

  1-2 year

Study Arms (3)

Natural labour group

Other: Hysteroscopy

Cesarean scar group

Other: Hysteroscopy

Cesarean with diverticulum (PCSD) group

Other: Hysteroscopy

Interventions

Hysteroscopy OTHER

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.

Also known as: assisted reproductive medicine

Cesarean scar group; Cesarean with diverticulum (PCSD) group; Natural labour group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital,Sun Yat-Sen University

Guandong, China

RECRUITING

MeSH Terms

Interventions

Hysteroscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Xing Yang, M.D. & Ph.D

  The Sixth Affiliated Hospital, Sun Yat-sen University

  STUDY CHAIR

• Xaoyan Liang, M.D. & Ph.D

  The Sixth Affiliated Hospital, Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Xing Yang, M.D. & Ph.D

CONTACT

020-38048013; yxing_8358@126.com

Xing Yang, M.D. & Ph.D

CONTACT

020-38048010

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: August 1, 2019
• Primary Completion: August 1, 2022
• Study Completion: April 1, 2023
• Last Updated: December 24, 2019

Record last verified: 2019-12

Locations

CN (1)