Cesarean Section Scar Niche: The Impact on ART Outcome

Recruiting

• Conditions: Cesarean Section; ART

• Registration Number: NCT05358678
• Lead Sponsor: Rahem Fertility Center

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.

Study Timeline

• Study First Submitted: 2022-03-22
• Study First Submitted QC: 2022-04-28
• Study First Posted: 2022-05-03
• Study Start: 2022-05-25
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 266

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy	6 weeks	Clinical pregnancy: A pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs.

Trial Locations

Locations (1)

Rahem Fertility Center; 🇪🇬 Zagazig, Egypt