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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

266 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-22

Study Completion Date

2024-10-01

Brief Summary

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the presence of cesarean section niche has adverse effects on success of ART outcome

Detailed Description

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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.

Conditions

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Cesarean Section Niche Impact on ART

Keywords

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Cesarean Section niche

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Rana Nabil Mohamed Attia

Assistant lecturer of obstetrics and gynaecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zagazig university

Zagazig, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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eman elgingy, M.D

Role: CONTACT

Phone: +20 122 749 1143

Email: [email protected]

shahenda saleh, M.D

Role: CONTACT

Phone: +20 100 110 9730

Email: [email protected]" <[email protected]>

Facility Contacts

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rana nabil, msc

Role: primary

Eman ElGindy, MD, PhD

Role: backup

Other Identifiers

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9385-22-3-2022

Identifier Type: -

Identifier Source: org_study_id