Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-30 @ 11:56 AM
Study NCT ID:
NCT05528835
Status:
COMPLETED
Last Update Posted:
2023-08-28
First Post:
2022-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Caesarean Section and Intracytoplasmic Sperm Injection (ICSI) Outcome
Sponsor:
Alexandria University
Organization:
Study Overview
Official Title:
Effect of Prior Caesarean Delivery on ICSI Outcome
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although Caesarean section (CS) is often a necessary surgical intervention, it may also be associated with an increased risk of short- and long-term sequelae. It was thought that CS may increase the risk of female subfertility or even infertility. In assisted reproductive technology (ART) cycles, the process of implantation is believed to be the most important factor in determining pregnancy outcome. In view of conflicting results on the influence of a previous CS on outcomes of ART, this study will be conducted to investigate the impact of the mode of previous delivery on ICSI outcomes.
Detailed Description:
The use of CS has steadily increased worldwide and will continue increasing over the current decade where both unmet need and overuse are expected to coexist. The medical field now acknowledges a patient's right to actively participate in her choice of medical treatments, including the method of delivery what is known as CS on demand, a primary CS performed on the mother's request without any recognized medical or obstetric Indications that may also increase the rate of C.S. Although CS is often a necessary surgical intervention, it may also be associated with an increased risk of short- and long-term sequelae eg. infection, haemorrhage and increased risk of several obstetric complications in subsequent pregnancies, including mal-placentation, Caesarean scar pregnancies, morbidly adherent placentae and uterine rupture. It was thought that CS may increase the risk of female subfertility or even infertility. The possible reasons for this impact on fertility may be related to infections, adhesions formation, placental bed disruption or other non-medical factors (age, culture, education). Different mechanisms were hypothesized to explain the detrimental uterine environment associated with the presence of CS niche, that may lead to subfertility including accumulation of intrauterine fluid, altered immunobiology, increased inflammation, distorted contractility of the uterus caused by fibrosis or interruption of the myometrial layer at the site of the niche. In ART cycles, the process of implantation is believed to be the most important factor in determining pregnancy outcome, because the embryos are directly transferred into the uterine cavity and so the tubal factor can be excluded. To date, knowledge on the influence of a previous CS on outcomes of ART is limited with different conclusions in terms of live birth, miscarriage and implantation rates. In view of these conflicting results, more adequately powered studies are warranted. Therefore, this study will be conducted to investigate the impact of the mode of previous delivery on ICSI outcomes.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: