Hysterosalpingography and Hysteroscopy in ICSI

• Sponsor: Aljazeera Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04778319
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.5
• Patients Per Site Per Month: 17.4

Study Details

Study Description

Brief Summary

unexplained infertility is a rising problem in clinical practice

Condition or Disease	Intervention/Treatment	Phase
Infertility	Other: occlusion of tubes; Other: non occlusion of tubes	N/A

Detailed Description

Assessment of uterine cavity is very important before ICSI

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Hysterosalpingography and Hysteroscopy in Intracytoplasmic Sperm Injection
• Anticipated Study Start Date: Mar 2, 2021
• Anticipated Primary Completion Date: Feb 1, 2022
• Anticipated Study Completion Date: Feb 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: tubal occlusion occlusion of tubes	Other: occlusion of tubes; to occlude the fallopian tubes
Sham Comparator: non occlusion of tube non occlusion of tubes	Other: non occlusion of tubes; not to occlude the tubes

Outcome Measures

Primary Outcome Measures

1. the number of women who will become pregnant [3 months]

   number of women who will have positive pregnancy test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 42 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• women with infertility

Exclusion Criteria:

• women with medical disorders

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aljazeera( Al Gazeera) hospital	Giza		Egypt

Sponsors and Collaborators

• Aljazeera Hospital

Investigators

• Principal Investigator: Mahmoud Alalfy, Algezeera hospitaland National Research Centre ,Egypt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aljazeera Hospital
• ClinicalTrials.gov Identifier: NCT04778319
• Other Study ID Numbers: tubal disease
• First Posted: Mar 3, 2021
• Last Update Posted: Mar 3, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Mar 3, 2021