Cesarean Section Niche Impact on ARTNCT05966558
Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome
An observational study of Cesarean Section Niche Impact on ART, run by Zagazig University at 1 site in Egypt.
Trial summary
the presence of cesarean section niche has adverse effects on success of ART outcome Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Cesarean Section Niche Impact on ART
- How many people
- 266 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jan 2020to 1 Oct 2024
- 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 18 to 37 years
- Women only
- Adult
Study population: It will be carried out in the department of Obstetrics and Gynecology, Zagazig University and in a private center.
Who may be able to join
- All women should have the following:
- Aged from 18 - 37 years old.
- Undergoing fresh ICSI cycles.
- A normal uterus with no anomalies or pathologies.
- At least one good-quality embryo/blastocyst available for transfer (3 BB and more according to Gardner and Schoolcraft grading system).
- Easy mockup embryo transfer (i.e. the catheter is smoothly inserted without touching the fundus, no cervix tenaculum is used and the catheter is clean of blood).
Who cannot join
- Younger than 18 or older than 37 years old.
- Congenital uterine abnormality or pathology.
- Presence of a hydrosalpinx.
- Chronic diseases which are not suitable for pregnancy.
- ICSI cycles with fresh or frozen TESE samples.
Trial locations and contacts
1 site in 1 country.
shahenda saleh, M.D contact
shahendasaleh20102015ss@gmail.com" <shahendasaleh20102015ss@gmail.com>
Egypt1 site, 1 recruiting
- Recruiting
Zagazig university
Zagazig, 44511
rana nabil, msc, 01005899460, rananabil51@gmail.com
Eman ElGindy, MD, PhD, 01227491143, eman_elgindy2013@hotmail.com
About this study
the presence of cesarean section niche has adverse effects on success of ART outcome
Read the detailed description
A common finding by ultrasound in secondary infertility patients with previous cesarean sections is the presence of niche, which is formally defined as an indentation of the uterine myometrium of at least 2 mm at the site of the caesarean scar. The most common symptom of niche is abnormal uterine bleeding, other symptoms include dysmenorrhea, chronic pelvic pain, dyspareunia, and sub-fertility/infertility.
It has been reported that a niche can reduce the chances of embryo implantation and may lead to spontaneous miscarriages if the implantation is close to or in the niche. The presence of a niche may render the actual embryo transfer procedure technically more difficult, and clinicians need to be aware of its presence and perform the transfer under ultrasound guidance to ensure the catheter bypasses the niche and enters the uterine cavity. Still the impact of c.s niche and its characteristics on outcome of ART is not clear.
- Conditions
- Cesarean Section Niche Impact on ART
- Keywords
- Cesarean Section niche
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of cesarean section scar niche on ongoing pregnancy rate in ART cycles.
cesarean section scar niche will be measured by TVS
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start22 Jan 2020
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section Niche Impact on ARTStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rana Nabil Mohamed Attia, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966558
- Sponsor's protocol ID
- 9385-22-3-2022
- Status last verified
- Jul 2023
- First submitted
- 20 Jan 2021
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome
- ClinicalTrials.gov ID
- NCT05966558
- Acronym / sponsor ID
- 9385-22-3-2022
- Conditions
- Cesarean Section Niche Impact on ART
- Keywords
- Cesarean Section niche
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 28 Jul 2023 (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.
the presence of cesarean section niche has adverse effects on success of ART outcome
Detailed description
A common finding by ultrasound in secondary infertility patients with previous cesarean sections is the presence of niche, which is formally defined as an indentation of the uterine myometrium of at least 2 mm at the site of the caesarean scar. The most common symptom of niche is abnormal uterine bleeding, other symptoms include dysmenorrhea, chronic pelvic pain, dyspareunia, and sub-fertility/infertility.
It has been reported that a niche can reduce the chances of embryo implantation and may lead to spontaneous miscarriages if the implantation is close to or in the niche. The presence of a niche may render the actual embryo transfer procedure technically more difficult, and clinicians need to be aware of its presence and perform the transfer under ultrasound guidance to ensure the catheter bypasses the niche and enters the uterine cavity. Still the impact of c.s niche and its characteristics on outcome of ART is not clear.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- It will be carried out in the department of Obstetrics and Gynecology, Zagazig University and in a private center.
Key inclusion criteria (6 listed)
- All women should have the following:
Key exclusion criteria (5 listed)
- Younger than 18 or older than 37 years old.
- Congenital uterine abnormality or pathology.
- Presence of a hydrosalpinx.
- Chronic diseases which are not suitable for pregnancy.
- ICSI cycles with fresh or frozen TESE samples.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Effect of cesarean section scar niche on ongoing pregnancy rate in ART cycles.
Time frame: 2 years
cesarean section scar niche will be measured by TVS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Cesarean Section Niche Impact on ART
Active, not recruitingObservational study
The Impact of Cesarean Scar Defects on the Success of Assisted Human Reproduction
Cesarean Section; Dehiscence
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.
shahenda saleh, M.D contact
shahendasaleh20102015ss@gmail.com" <shahendasaleh20102015ss@gmail.com>
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 Cesarean Section Niche Impact on ART, run by Zagazig University at 1 site in Egypt.
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 6 inclusion and 5 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 28 Jul 2023. 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 Egypt. 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 eman elgingy, M.D (+20 122 749 1143, eman_elgindy2013@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Effect of cesarean section scar niche on ongoing pregnancy rate in ART cycles. (time frame: 2 years). 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 28 Jul 2023.