Infertile Patients With Previous Live BirthNCT04070222
The Outcome and Influence Factors of Assisted Reproductive Therapy in Patients With Cesarean Scar Uterus.
An observational study of Infertile Patients With Previous Live Birth, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertile Patients With Previous Live Birth
- What is being tested?
- Hysteroscopy
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to Apr 2023
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
Xing Yang, M.D. & Ph.D contact
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital,Sun Yat-Sen University
Guandong
About this study
Official title: 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.
Read the 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.
- Being tested
- Hysteroscopy
- Keywords
- Secondary infertility, cesarean section, post-cesarean section scar diverticulum , endometrial microflora, inflammatory markers, clinical pregnancy, live birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysteroscopyOther
Also called assisted reproductive medicine
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Natural labour group | Not described Receives: Other: Hysteroscopy | |
| Cesarean scar group | Not described Receives: Other: Hysteroscopy | |
| Cesarean with diverticulum (PCSD) group | Not described Receives: Other: Hysteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-2 year
Secondary outcomes (4)
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.
Measured: 1-2 year
Biochemical pregnancy rate
Biochemical pregnancy rate(%): number of biochemical pregnancy/transferred cycle.
Measured: 1-2 year
Embryo implantation rate
Embryo implantation rate(%): number of gestational sac / transferred embryo.
Measured: 1-2 year
Live birth rate
Live birth rate(%): number of live birth/ transferred cycle.
Measured: 1-2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Aug 2019
- Primary completionAug 2022 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertile Patients With Previous Live BirthStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
- Investigators
- Xing Yang, M.D. & Ph.D, Study chair, Sixth Affiliated Hospital, Sun Yat-sen UniversityXaoyan Liang, M.D. & Ph.D, Study director, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070222
- Sponsor's protocol ID
- newivf20190807
- Status last verified
- Dec 2019
- First submitted
- 22 Aug 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Case-control Study of the Outcome and Influence Factors of Assisted Reproductive Therapy in Patients With Cesarean Scar Uterus.
- ClinicalTrials.gov ID
- NCT04070222
- Acronym / sponsor ID
- newivf20190807
- Keywords
- Secondary infertility, cesarean section, post-cesarean section scar diverticulum , endometrial microflora, inflammatory markers, clinical pregnancy, live birth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Natural labour group | – | Other: Hysteroscopy |
| Cesarean scar group | – | Other: Hysteroscopy |
| Cesarean with diverticulum (PCSD) group | – | Other: Hysteroscopy |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HysteroscopyAlso: assisted reproductive medicine1. 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 | Cesarean scar group, Cesarean with diverticulum (PCSD) group, Natural labour group |
Primary outcome
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.
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.
4 secondary outcomes
Clinical pregnancy rate
Time frame: 1-2 year
Biochemical pregnancy rate
Time frame: 1-2 year
Embryo implantation rate
Time frame: 1-2 year
Live birth rate
Time frame: 1-2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xing Yang, M.D. & Ph.D contact
Xing Yang, M.D. & Ph.D study chair
Sixth Affiliated Hospital, Sun Yat-sen University
Xaoyan Liang, M.D. & Ph.D study director
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertile Patients With Previous Live Birth, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xing Yang, M.D. & Ph.D (020-38048013, yxing_8358@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Species and communities of uterine microflora (time frame: 1-2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.