Cesarean Section; DehiscenceNICHE-ARTNCT04869007
The Impact of Cesarean Scar Defects on the Success of Assisted Human Reproduction
An observational study of Cesarean Section; Dehiscence, run by University Hospital, Angers at 5 sites in France.
Trial summary
The prevalence of Caesarean sections continues to increase around the world. In France, the proportion of Caesarean sections has doubled from 11% in 1981 to 20,2% in 2016, bringing with it an increase in the risk of obstetrical complications. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Cesarean Section; Dehiscence
- What is being tested?
- hysterosonography
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 5 sitesFrance
- Study dates
- 30 May 2022to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 43 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients referred to an ART procedure for secundary infertility with a history of at least one cesarean section (single or multi-scarred uterus).
Who may be able to join
- Patients with a history of at least one cesarean section (single or multi-scarred uterus).
- Age between 18 and 43 years old
- Secondary infertility requiring ART techniques (FIV or FIV ICSI).
- A Hysterosonography examination as part of the pre-ART assessment allowing for the detection of the presence of an isthmocele.
- French speaking patients
- Patient affiliated to or beneficiary of a social security scheme
- Non-inclusion criteria :
- Refusal to participate in the study.
Who cannot join
None listed.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
UH Angers
Angers, 49933
Hospital Center Sud Francilien
Corbeil-Essonnes
Creteil University Hospital
Créteil
Tenon Hospital Paris
Paris
University Hospital of Rennes
Rennes
About this study
Official title: The Impact of Cesarean Scar Defects on the Success of Assisted Human Reproduction: The Prospective NICHE-ART Study
The prevalence of Caesarean sections continues to increase around the world. In France, the proportion of Caesarean sections has doubled from 11% in 1981 to 20,2% in 2016, bringing with it an increase in the risk of obstetrical complications.
Uterine defects, or Isthomcele, first defined by Morris in 1995 as a scarring abnormality with a dehiscence of the hysterotomy following a caesarean section. This purely iatrogenic pathology can cause inter-menstrual bleeding or pelvic pain.
Read more
Several definitions of isthmosceles exist in scientific literature with variations according to the nature of the reference examination chosen and the measurements made. However, for the majority of authors, isthmoceles are characterized by a residual myometrial thickness of less than 3 millimetres in the sagittal plane. The prevalence of isthmoceles amoung patients with a unicicatricial uterus is about 61%.
Currently, the main diagnostic technique for isthmoceles are 2D or 3D ultrasound and hysterosonography.
Small, non-controlled studies have found that surgical treatment of the isthmocele is effective in reducing metrorrhagia. In these studies, the authors noted that patients with metrorrhagia were also more frequently affected by secondary infertility.
A small number of non-comparative studies with a low level of evidence have looked into the efficacy of surgical treatment of isthmoceles on related symptoms: metrorraghia, pelvic pain and/or secondary infertility. Their results show an idiopathic secondary infertility rate in the presence of isthmoceles prior to surgical treatment of approximately 66%. Significantly higher pregnancy rates after treatment suggest that the surgical management of isthmoceles is worthwhile. However, these data suffer from not negligible selection bias.
The initial findings concerning fertility after surgical repair seem promising and some teams propose systematic surgical management of the isthmocele before a technique of assisted reproduction (ART) although without any evidence in literature.
Isthmocele surgery can result in uterine perforations, adhesions and intrauterine synechia known to be detrimental to future fertility.
The efficacy of surgical management of surgey must therefore be demonstrated prior to any attempts at treatment. This will require large prospective studies based on a consensual definition of isthmocele. The diagnosis using Hysterosonography is currently considered as the "gold standard" examination.
The main hypothesis of our study is that a significant isthmocele, defined by a residual myometrial thickness of less than 3mm, measured in the sagittal plane by hysterosonography, could alter the results of ART.
Read the detailed description
The study has a multicentric, parallel group, comparative, non-interventional, exploratory and prospective design.
Definition of isthmocele: defined as a dehiscence of the hysterotomy following a caesarean section. The residual myometrial thickness is less than 3mm, measured in the sagittal plane by hysterosonography.
The presence or absence of an isthmocele according to this definition will allow for the distribution of patients into one of two study groups : "isthmocele +" or "isthmocele -".
Definition of clinical pregnancy rate: defined as the presence of an intrauterine gestational sac and an embryo with cardiac activity visualized during an ultrasound examination at 7 weeks after embryo transfer.
Methods : During the initial ART consultation, the study is presented (oral information and distribution of a brochure) to patients consulting for infertility and with a history of cesarean section. It is during this consultation that the ART treatment assessment (blood tests and imaging: ultrasound and hysterosonography) is prescribed. If they agree to take part in the study, the non-opposition of eligible patients is collected during this consultation (pre-inclusion). Furthermore, among patients who agreed to participate in the study, socio-demographic data and the couple's medical history are collected during this initial consultation.
For patients who agreed to participate in the study, a specific measurement is made during the hysterosonography examination in order to determine the presence or absence of an isthmocele. Inclusion in the study is validated after a successful hysterosonography examination that confirms the presence or absence of an isthmocele. The patients are then attributed either to the: "isthmocele +" group or "isthmocele -" group.
During the second ART consultation, the results of the treatment assessment are collected, in particular the presence or absence of an isthmocele on the hysterosonography examination.
Subsequently, the data relative to ovarian stimulation, the methods of triggering and embryo transfer are collected prospectively by the investigator or co-investigators.
As part of the standard ART treatment, blood HCG tests are carried out 14 days after embryo transfer in order to detect a possible pregnancy. If the blood HCG levels are positive, the test is repeated 48 hours later and again a week later to survey the evolution of the blood HCG levels. At 6 to 7 weeks after oocyte puncture, an ultrasound scan is performed in the ART department if the blood HCGs level is greater than 10 IU/L with a satisfactory evolution after 48 hours. This data is collected for research purposes.
In the case of pregnancy and delivery in the same hospital as the ART treatment, obstetrical data is collected by the investigators or co-investigators from the obstetrical file. In the case of delivery at another facility, patients were contacted by telephone one year after a positive pregnancy test (HCG).
Discussion: No individual benefit is expected from this study since the management of the patients included corresponds to standard practice.
Concerning the collective benefits, if the conclusions of this study allow for the confirmation of our hypothesis (reduction in the pregnancy rate in the presence of a significant isthmocele), this could lead to a change in clinical practices in patients treated with ART. Indeed, surgical management of the isthmocele could be discussed prior to ART by informing the patient of the benefit-risk balance of the operation.
If our hypothesis of reduced fertility in the presence of isthmoceles is confirmed, further studies should ideally be carried out in order to demonstrate that the surgical management of isthmoceles improves the results of ART before systematically offering surgery to patients.
Trial Registration : The research protocole has been approuved by the relevant French authorities Comité de Protection des Personnes Sud Méditerranée IV on the 10th of November 2020 and recorded prospectively (before the inscription of the first participant) under the number ID-RCB : 2020-A02068-31.
- Conditions
- Cesarean Section; Dehiscence
- Being tested
- hysterosonography
- Keywords
- ceasarean scar defect, Isthmocele, in vitro Fecondation, Clinical pregnancy, live birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysterosonographyDevice
Isthmocele mesured by hysterosonography before ART procedure
| Study group | Role | What they receive |
|---|---|---|
| Patients with a history of cesarean section and a hysterosonographically diagnosed isthmocoele | For patients who agreed to participate in the study, a specific measurement is made during the hysterosonography examination in order to determine the presence or absence of an isthmocele. Inclusion in the study is validated after a successful hysterosonography examination that confirms the presence or absence of an isthmocele. The patients are then attributed either to the: "isthmocele +" group or "isthmocele -" group. Receives: Device: hysterosonography | |
| Patients with a history of cesarean section without isthmocoele hysterosonographically diagnosed | For patients who agreed to participate in the study, a specific measurement is made during the hysterosonography examination in order to determine the presence or absence of an isthmocele. Inclusion in the study is validated after a successful hysterosonography examination that confirms the presence or absence of an isthmocele. The patients are then attributed either to the: "isthmocele +" group or "isthmocele -" group. Receives: Device: hysterosonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant isthmocele and clinical pregnancy rates after ART procedure
A significant isthmocele (defined by a residual myometrial thickness of less than 3 mm in the sagittal plane, mesured by hysterosonography) could alter the results of ART (pregnancy rates). Definition of clinical pregnancy rate: defined as the presence of an intrauterine gestational sac and an embryo with cardiac activity visualized during an ultrasound examination at 7 weeks after embryo transfer
Measured: 12 months
Secondary outcomes (1)
The secondary objectives of the study explore the associations between the presence of an isthmocele and other criteria evaluating the results of IVF in patients with a scarred uterus
The secondary objectives of the study explore the associations between the presence of an isthmocele and other criteria evaluating the results of IVF (IVF or IVF ICSI) in patients with a scarred uterus (single or multi-scarred)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start30 May 2022
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cesarean Section; DehiscenceStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Guillaume LEGENDRE, MD PhD, Principal investigator, UH Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869007
- Sponsor's protocol ID
- 49RC20_0156
- Acronym
- NICHE-ART
- Status last verified
- Jul 2025
- First submitted
- 16 Aug 2020
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Spiezio Sardo A, Di Carlo C, Minozzi S, Spinelli M, Pistotti V, Alviggi C, De Placido G, Nappi C, Bifulco G. Efficacy of hysteroscopy in improving reproductive outcomes of infertile couples: a systematic review and meta-analysis. Hum Reprod Update. 2016 Jun;22(4):479-96. doi: 10.1093/humupd/dmw008. Epub 2016 Mar 23.
PubMed 27008893Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.
PubMed 23996650Donnez O, Jadoul P, Squifflet J, Donnez J. Laparoscopic repair of wide and deep uterine scar dehiscence after cesarean section. Fertil Steril. 2008 Apr;89(4):974-80. doi: 10.1016/j.fertnstert.2007.04.024. Epub 2007 Jul 10.
PubMed 17624346Osser OV, Jokubkiene L, Valentin L. High prevalence of defects in Cesarean section scars at transvaginal ultrasound examination. Ultrasound Obstet Gynecol. 2009 Jul;34(1):90-7. doi: 10.1002/uog.6395.
PubMed 19499514Jeremy B, Bonneau C, Guillo E, Paniel BJ, Le Tohic A, Haddad B, Madelenat P. [Uterine ishtmique transmural hernia: results of its repair on symptoms and fertility]. Gynecol Obstet Fertil. 2013 Oct;41(10):588-96. doi: 10.1016/j.gyobfe.2013.08.005. Epub 2013 Oct 4. French.
PubMed 24094595Astruc A, Deseine D, Spiers A, Boguenet M, May-Panloup P, Bouet PE, Legendre G. Impact of caesarean scar defects on the success of assisted human reproduction: the NICHE-ART prospective French cohort study protocol. BMJ Open. 2024 Dec 7;14(12):e092011. doi: 10.1136/bmjopen-2024-092011.
PubMed 39645254
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Cesarean Scar Defects on the Success of Assisted Human Reproduction: The Prospective NICHE-ART Study
- ClinicalTrials.gov ID
- NCT04869007
- Acronym / sponsor ID
- NICHE-ART / 49RC20_0156
- Conditions
- Cesarean Section; Dehiscence
- Keywords
- ceasarean scar defect, Isthmocele, in vitro Fecondation, Clinical pregnancy, live birth
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 30 May 2022 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 3 May 2021 (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 prevalence of Caesarean sections continues to increase around the world. In France, the proportion of Caesarean sections has doubled from 11% in 1981 to 20,2% in 2016, bringing with it an increase in the risk of obstetrical complications.
Uterine defects, or Isthomcele, first defined by Morris in 1995 as a scarring abnormality with a dehiscence of the hysterotomy following a caesarean section. This purely iatrogenic pathology can cause inter-menstrual bleeding or pelvic pain.
Several definitions of isthmosceles exist in scientific literature with variations according to the nature of the reference examination chosen and the measurements made. However, for the majority of authors, isthmoceles are characterized by a residual myometrial thickness of less than 3 millimetres in the sagittal plane. The prevalence of isthmoceles amoung patients with a unicicatricial uterus is about 61%.
Currently, the main diagnostic technique for isthmoceles are 2D or 3D ultrasound and hysterosonography.
Small, non-controlled studies have found that surgical treatment of the isthmocele is effective in reducing metrorrhagia. In these studies, the authors noted that patients with metrorrhagia were also more frequently affected by secondary infertility.
A small number of non-comparative studies with a low level of evidence have looked into the efficacy of surgical treatment of isthmoceles on related symptoms: metrorraghia, pelvic pain and/or secondary infertility. Their results show an idiopathic secondary infertility rate in the presence of isthmoceles prior to surgical treatment of approximately 66%. Significantly higher pregnancy rates after treatment suggest that the surgical management of isthmoceles is worthwhile. However, these data suffer from not negligible selection bias.
The initial findings concerning fertility after surgical repair seem promising and some teams propose systematic surgical management of the isthmocele before a technique of assisted reproduction (ART) although without any evidence in literature.
Isthmocele surgery can result in uterine perforations, adhesions and intrauterine synechia known to be detrimental to future fertility.
The efficacy of surgical management of surgey must therefore be demonstrated prior to any attempts at treatment. This will require large prospective studies based on a consensual definition of isthmocele. The diagnosis using Hysterosonography is currently considered as the "gold standard" examination.
The main hypothesis of our study is that a significant isthmocele, defined by a residual myometrial thickness of less than 3mm, measured in the sagittal plane by hysterosonography, could alter the results of ART.
Detailed description
The study has a multicentric, parallel group, comparative, non-interventional, exploratory and prospective design.
Definition of isthmocele: defined as a dehiscence of the hysterotomy following a caesarean section. The residual myometrial thickness is less than 3mm, measured in the sagittal plane by hysterosonography.
The presence or absence of an isthmocele according to this definition will allow for the distribution of patients into one of two study groups : "isthmocele +" or "isthmocele -".
Definition of clinical pregnancy rate: defined as the presence of an intrauterine gestational sac and an embryo with cardiac activity visualized during an ultrasound examination at 7 weeks after embryo transfer.
Methods : During the initial ART consultation, the study is presented (oral information and distribution of a brochure) to patients consulting for infertility and with a history of cesarean section. It is during this consultation that the ART treatment assessment (blood tests and imaging: ultrasound and hysterosonography) is prescribed. If they agree to take part in the study, the non-opposition of eligible patients is collected during this consultation (pre-inclusion). Furthermore, among patients who agreed to participate in the study, socio-demographic data and the couple's medical history are collected during this initial consultation.
For patients who agreed to participate in the study, a specific measurement is made during the hysterosonography examination in order to determine the presence or absence of an isthmocele. Inclusion in the study is validated after a successful hysterosonography examination that confirms the presence or absence of an isthmocele. The patients are then attributed either to the: "isthmocele +" group or "isthmocele -" group.
During the second ART consultation, the results of the treatment assessment are collected, in particular the presence or absence of an isthmocele on the hysterosonography examination.
Subsequently, the data relative to ovarian stimulation, the methods of triggering and embryo transfer are collected prospectively by the investigator or co-investigators.
As part of the standard ART treatment, blood HCG tests are carried out 14 days after embryo transfer in order to detect a possible pregnancy. If the blood HCG levels are positive, the test is repeated 48 hours later and again a week later to survey the evolution of the blood HCG levels. At 6 to 7 weeks after oocyte puncture, an ultrasound scan is performed in the ART department if the blood HCGs level is greater than 10 IU/L with a satisfactory evolution after 48 hours. This data is collected for research purposes.
In the case of pregnancy and delivery in the same hospital as the ART treatment, obstetrical data is collected by the investigators or co-investigators from the obstetrical file. In the case of delivery at another facility, patients were contacted by telephone one year after a positive pregnancy test (HCG).
Discussion: No individual benefit is expected from this study since the management of the patients included corresponds to standard practice.
Concerning the collective benefits, if the conclusions of this study allow for the confirmation of our hypothesis (reduction in the pregnancy rate in the presence of a significant isthmocele), this could lead to a change in clinical practices in patients treated with ART. Indeed, surgical management of the isthmocele could be discussed prior to ART by informing the patient of the benefit-risk balance of the operation.
If our hypothesis of reduced fertility in the presence of isthmoceles is confirmed, further studies should ideally be carried out in order to demonstrate that the surgical management of isthmoceles improves the results of ART before systematically offering surgery to patients.
Trial Registration : The research protocole has been approuved by the relevant French authorities Comité de Protection des Personnes Sud Méditerranée IV on the 10th of November 2020 and recorded prospectively (before the inscription of the first participant) under the number ID-RCB : 2020-A02068-31.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with a history of cesarean section and a hysterosonographically diagnosed isthmocoele | – | Device: hysterosonographyFor patients who agreed to participate in the study, a specific measurement is made during the hysterosonography examination in order to determine the presence or absence of an isthmocele. Inclusion in the study is validated after a successful hysterosonography examination that confirms the presence or absence of an isthmocele. The patients are then attributed either to the: "isthmocele +" group or "isthmocele -" group. |
| Patients with a history of cesarean section without isthmocoele hysterosonographically diagnosed | – | Device: hysterosonographyFor patients who agreed to participate in the study, a specific measurement is made during the hysterosonography examination in order to determine the presence or absence of an isthmocele. Inclusion in the study is validated after a successful hysterosonography examination that confirms the presence or absence of an isthmocele. The patients are then attributed either to the: "isthmocele +" group or "isthmocele -" group. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients referred to an ART procedure for secundary infertility with a history of at least one cesarean section (single or multi-scarred uterus).
Key inclusion criteria (8 listed)
- Patients with a history of at least one cesarean section (single or multi-scarred uterus).
- Age between 18 and 43 years old
- Secondary infertility requiring ART techniques (FIV or FIV ICSI).
- A Hysterosonography examination as part of the pre-ART assessment allowing for the detection of the presence of an isthmocele.
- French speaking patients
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| hysterosonographyIsthmocele mesured by hysterosonography before ART procedure | Device | Patients with a history of cesarean section and a hysterosonographically diagnosed isthmocoele, Patients with a history of cesarean section without isthmocoele hysterosonographically diagnosed |
Primary outcome
Significant isthmocele and clinical pregnancy rates after ART procedure
Time frame: 12 months
A significant isthmocele (defined by a residual myometrial thickness of less than 3 mm in the sagittal plane, mesured by hysterosonography) could alter the results of ART (pregnancy rates). Definition of clinical pregnancy rate: defined as the presence of an intrauterine gestational sac and an embryo with cardiac activity visualized during an ultrasound examination at 7 weeks after embryo transfer
1 secondary outcome
The secondary objectives of the study explore the associations between the presence of an isthmocele and other criteria evaluating the results of IVF in patients with a scarred uterus
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Background: PubMed 27008893Di Spiezio Sardo A, Di Carlo C, Minozzi S, Spinelli M, Pistotti V, Alviggi C, De Placido G, Nappi C, Bifulco G. Efficacy of hysteroscopy in improving reproductive outcomes of infertile couples: a systematic review and meta-analysis. Hum Reprod Update. 2016 Jun;22(4):479-96. doi: 10.1093/humupd/dmw008. Epub 2016 Mar 23.
- Background: PubMed 23996650Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.
- Background: PubMed 17624346Donnez O, Jadoul P, Squifflet J, Donnez J. Laparoscopic repair of wide and deep uterine scar dehiscence after cesarean section. Fertil Steril. 2008 Apr;89(4):974-80. doi: 10.1016/j.fertnstert.2007.04.024. Epub 2007 Jul 10.
- Background: PubMed 19499514Osser OV, Jokubkiene L, Valentin L. High prevalence of defects in Cesarean section scars at transvaginal ultrasound examination. Ultrasound Obstet Gynecol. 2009 Jul;34(1):90-7. doi: 10.1002/uog.6395.
- Background: PubMed 24094595Jeremy B, Bonneau C, Guillo E, Paniel BJ, Le Tohic A, Haddad B, Madelenat P. [Uterine ishtmique transmural hernia: results of its repair on symptoms and fertility]. Gynecol Obstet Fertil. 2013 Oct;41(10):588-96. doi: 10.1016/j.gyobfe.2013.08.005. Epub 2013 Oct 4. French.
- Derived from this study: PubMed 39645254Astruc A, Deseine D, Spiers A, Boguenet M, May-Panloup P, Bouet PE, Legendre G. Impact of caesarean scar defects on the success of assisted human reproduction: the NICHE-ART prospective French cohort study protocol. BMJ Open. 2024 Dec 7;14(12):e092011. doi: 10.1136/bmjopen-2024-092011.
- Individual participant dataSharing planned: No
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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.
Guillaume LEGENDRE, MD PhD principal investigator
UH Angers
5 sites 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; Dehiscence, run by University Hospital, Angers at 5 sites in France.
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 8 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant isthmocele and clinical pregnancy rates after ART procedure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04869007, which also lists 6 linked publications.
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 26 Jun 2026.