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Cesarean Section Scar Niche: The Impact on ART Outcome

Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05358678
Enrollment
266
Registered
2022-05-03
Start date
2022-05-25
Completion date
2023-05-31
Last updated
2022-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ART, Cesarean Section

Keywords

Cesarean Section niche, ART

Brief summary

To evaluate the impact of the presence of cesarean section niche and its characteristics on the outcome of ART cycles.

Detailed description

The incidence of Cesarean section (CS) is increasing worldwide, with a corresponding increase in its associated complications. The well-known complications are infection, hemorrhage, and increased risk of obstetric complications in subsequent pregnancies, like morbidly adherent placenta, cs scar pregnancies and uterine rupture. In addition, some studies emphasize the effect of cesarean sections on reduced fertility. A meta-analysis reported that a Caesarean section reduces the probability of subsequent pregnancy by 10%, compared with a previous vaginal delivery. The cesarean section niche is 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. Meanwhile, other symptoms include dysmenorrhea, chronic pelvic pain, dyspareunia, and sub-fertility/infertility. The detection of a cesarean section niche depends on the operator and the diagnostic method used. This can be 2D, 3D transvaginal sonography, sonohysterography or hysteroscopy. Regarding ART, the presence of cs niche was reported to reduce the chances of embryo implantation, and increase the rate of spontaneous miscarriages, especially if the implantation is close to it or in the niche. The presence of a niche may increase the difficulty of embryo transfer procedure, clinicians need to be aware of its presence and the transfer should be done 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.

Interventions

DIAGNOSTIC_TESTcs niche group

A niche is formally defined by the European Niche Taskforce as an indentation of the uterine myometrium of at least 2 mm at the site of the CS scars. A niche can be sub classified as follows: 1. Simple niche 2. Simple niche with one branch 3. Complex niche (with more than one branch). The following measurements will be taken: * Length. * Depth. * Width. * RMT (residual myometrium thickness). * AMT (adjacent myometrium thickness). * Distance between the niche and the VV (vesico-vaginal) fold. * Distance between the niche and the external os. We will also comment on the position of the uterus (AVF or RVF), presence or absence of intra cavitary fluid and its thickness.

Sponsors

Zagazig University
CollaboratorOTHER_GOV
Rahem Fertility Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 37 Years

Inclusion criteria

1. Aged from 18 - 37 years old. 2. Having a history of one or more previous CS with ultrasonographic visible cesarean section niche (for the group with cs scar niche), which is regarding to European Niche Taskforce is an indentation of the uterine myometrium of at least 2 mm at the site of the CS scar (Jordans et al., 2019). 3. A normal uterus with no anomalies or pathologies. 4. At least one good-quality embryo available for transfer.

Exclusion criteria

1. Younger than 18 or older than 37 years old. 2. Congenital uterine abnormality or pathology. 3. Presence of a hydrosalpinx. 4. ICSI cycles with TESE samples.

Design outcomes

Primary

MeasureTime frameDescription
The effect of cesarean scar niche and its characteristics on ongoing pregnancy rate of ART cycles.3 monthsOngoing pregnancy: defined as a viable intrauterine pregnancy of at least 12 weeks duration confirmed on an ultrasound scan

Secondary

MeasureTime frameDescription
Clinical pregnancy6 weeksClinical pregnancy: A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs.

Countries

Egypt

Contacts

Primary ContactRana nabil, MSc
rananabil51@gmail.com01005899460

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026