Office Hysteroscopy and Endometrial Snip Improve Intrauterine Insemination Outcome

NCT ID: NCT01544426

Last Updated: 2014-12-30

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Infertility

Keywords

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Office hysteroscopy, intrauterine insemination endometrial scrap

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Office hysteroscopy and endometrial snip

Office hysteroscopy and endometrial snip

Group Type EXPERIMENTAL

Office hysteroscopy and endometrial snip

Intervention Type PROCEDURE

Office hysteroscopy with endometrial snip

Office hyteroscopy

Office hysteroscopy

Group Type ACTIVE_COMPARATOR

Office hysteroscopy

Intervention Type PROCEDURE

Office hysteroscopy

Interventions

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Office hysteroscopy and endometrial snip

Office hysteroscopy with endometrial snip

Intervention Type PROCEDURE

Office hysteroscopy

Office hysteroscopy

Intervention Type PROCEDURE

Other Intervention Names

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Office hysteroscopy combined with endometrial snip Outpatient hysteroscopy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Waleed El-khayat

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Waleed El-khayat, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Kasr Al-AINY hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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El-Khayat W, Elsadek M, Saber W. RETRACTED: Comparing the effect of office hysteroscopy with endometrial scratch versus office hysteroscopy on intrauterine insemination outcome: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2015 Nov;194:96-100. doi: 10.1016/j.ejogrb.2015.08.025. Epub 2015 Aug 28.

Reference Type DERIVED
PMID: 26344351 (View on PubMed)

Other Identifiers

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42012

Identifier Type: -

Identifier Source: org_study_id