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NCT01544426 Clinical Trial

Office Hysteroscopy and Endometrial Snip Improve Intrauterine Insemination Outcome

Infertility Clinical Trial

Official title:
Does Office Hysteroscopy and Endometrial Snip Improve IUI Outcome? : a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01544426
Other study ID # 42012
Secondary ID
Status Completed
Phase Phase 3
First received February 26, 2012
Last updated December 27, 2014
Start date February 2012
Est. completion date October 2014

Study information
Verified date December 2014
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority Egypt: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Endometrial injury had been studied before prior to intracytoplasmic sperm injection (ICSI) cycles , in cases of repeated implantation failure. It is found that it will improve the implantation rate.

Description:

The investigators can combine office hysteroscopy to diagnose hidden endometrial pathology, with hysteroscopically guided endometrial snip from the fundus of the uterus, trying to improve the pregnancy rate.

Recruitment information / eligibility
Status Completed
Enrollment 332
Est. completion date October 2014
Est. primary completion date September 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 38 Years
Eligibility Inclusion Criteria:

- 18- 38 years old

- at least one patent tube

- unexplained infertility, anovulation, mild to moderate male factor infertility

- previous failed IUI

Exclusion Criteria:

- indicated for ICSI

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Office hysteroscopy and endometrial snip
Office hysteroscopy with endometrial snip
• Office hysteroscopy
Office hysteroscopy

Locations
Country Name City State
Egypt Kasr Al-AINY hospital Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical pregnancy rate Positive pregnancy test with fetal heart activity 10 month No
Secondary Ongoing pregnancy rate Pregnancy Continued after 12weeks 12 month No
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