The Impact of Cesarean Scar Defects on the Success of Assisted Human Reproduction

NCT04869007 | Recruiting

• 1 other identifier: 49RC20_0156
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 9

Brief 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. 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.

Conditions

Cesarean Section; Dehiscence

Keywords

ceasarean scar defect; Isthmocele; in vitro Fecondation; Clinical pregnancy; live birth

Outcome Measures

Primary Outcomes (1)

• 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

  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

  12 months

Study Arms (2)

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.

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.

Device: hysterosonography

Interventions

hysterosonography DEVICE

Isthmocele mesured by hysterosonography before ART procedure

Patients with a history of cesarean section and a hysterosonographically diagnosed isthmocoele; Patients with a history of cesarean section without isthmocoele hysterosonographically diagnosed

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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
• \- Refusal to participate in the study.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (9)

UH Angers

Angers, 49933, France

RECRUITING

University Hospital of Brest

Brest, France

RECRUITING

Hospital Center Sud Francilien

Corbeil-Essonnes, France

RECRUITING

Creteil University Hospital

Créteil, France

RECRUITING

University Hospital of Nimes

Nîmes, France

RECRUITING

Tenon Hospital Paris

Paris, France

RECRUITING

La Sagesse Clinic

Rennes, France

RECRUITING

University Hospital of Rennes

Rennes, France

RECRUITING

University Hospital of Saint Etienne

Saint-Etienne, France

RECRUITING

Related Publications (6)

• 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.

  PMID: 27008893 BACKGROUND

• Bij 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.

  PMID: 23996650 BACKGROUND

• Donnez 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.

  PMID: 17624346 BACKGROUND

• Osser 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.

  PMID: 19499514 BACKGROUND

• Jeremy 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.

  PMID: 24094595 BACKGROUND

• Astruc 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.

  PMID: 39645254 DERIVED

Study Officials

• Guillaume LEGENDRE, MD PhD

  UH Angers

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume LEGENDRE, MD PhD

CONTACT

024154459; guillaume.legendre@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2020
• First Posted: May 3, 2021
• Study Start: May 30, 2022
• Primary Completion: November 30, 2025
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)