Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome

• Sponsor: Aljazeera Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03683771
• Collaborator: Kasr El Aini Hospital (Other), National research centre (Other)
• Enrollment: 120
• Locations: 2
• Anticipated Duration (Months): 4.8
• Patients Per Site: 60
• Patients Per Site Per Month: 12.6

Study Details

Study Description

Brief Summary

Despite constant progress in in vitro fertilization (IVF) techniques and ovarian stimulation, pregnancy and embryo implantation rates remain modest . The phenomenon of embryo implantation depends both on the embryo itself and on endometrial receptivity

Condition or Disease	Intervention/Treatment	Phase
Infertility	Diagnostic Test: Transvaginal US with Doppler study

Detailed Description

A favorable uterine medium is necessary for embryo implantation, but endometrial receptivity can be negatively affected by ovarian stimulation . Study of endometrial receptivity is especially limited in the context of IVF cycles .

Biopsy of the endometrium cannot be considered during the treatment, and this has encouraged the development and use of ultrasonography and Doppler-like non-invasive methods to evaluate ovarian response to the stimulation and uterine receptivity .

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Assessment of Endometrial Pattern and Sub-endometrial Vascularity in Prediction of Pregnancy Rate in ICSI
• Actual Study Start Date: Sep 28, 2018
• Anticipated Primary Completion Date: Feb 15, 2019
• Anticipated Study Completion Date: Feb 20, 2019

Outcome Measures

Primary Outcome Measures

1. The number of patients who will have positive pregnancy rate [within 2 months]

   patients who will get pregnant in ICSI cycle with measuring their doppler indices before ovum pick up

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Maternal age from 20 to 40 years. Women with BMI range from 20 - 35 Women diagnosed with primary infertility

Exclusion Criteria:

Maternal chronic medical disorder (diabetes mellitus or hypertension). Women diagnosed with autoimmune diseases or antiphospholipid syndrome

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kasralainy hospital	Cairo		Egypt
2	Algazeerah and Kasralainy hospital	Giza		Egypt

Sponsors and Collaborators

• Aljazeera Hospital
• Kasr El Aini Hospital
• National research centre

Investigators

• Study Chair: Mahmoud Alalfy, Algazeerah hospital -Location (Giza -Egypt ) and National Research centre egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aljazeera Hospital
• ClinicalTrials.gov Identifier: NCT03683771
• Other Study ID Numbers: ICSI vascularity
• First Posted: Sep 25, 2018
• Last Update Posted: Jan 9, 2019
• Last Verified: Jan 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Jan 9, 2019