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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05966558

Enrollment

266

Registered

2023-07-28

Start date

2020-01-22

Completion date

2024-10-01

Last updated

2023-07-28

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

Conditions

Cesarean Section Niche Impact on ART

Keywords

Cesarean Section niche

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 37 Years

Inclusion criteria

* 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).

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
The Effect of cesarean section scar niche on ongoing pregnancy rate in ART cycles.	2 years	cesarean section scar niche will be measured by TVS

Countries

Egypt

Contacts

Primary Contacteman elgingy, M.D

eman_elgindy2013@hotmail.com+20 122 749 1143

Backup Contactshahenda saleh, M.D

shahendasaleh20102015ss@gmail.com <shahendasaleh20102015ss@gmail.com>+20 100 110 9730

Outcome results