NCT01544426

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
332

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 6, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 30, 2014

Status Verified

December 1, 2014

Enrollment Period

2.6 years

First QC Date

February 26, 2012

Last Update Submit

December 27, 2014

Conditions

Infertility

Keywords

Office hysteroscopy,intrauterine inseminationendometrial scrap

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    Positive pregnancy test with fetal heart activity

    10 month

Secondary Outcomes (1)

  • Ongoing pregnancy rate

    12 month

Study Arms (2)

Office hysteroscopy and endometrial snip

EXPERIMENTAL

Office hysteroscopy and endometrial snip

Procedure: Office hysteroscopy and endometrial snip

Office hyteroscopy

ACTIVE COMPARATOR

Office hysteroscopy

Procedure: Office hysteroscopy

Interventions

Office hysteroscopy and endometrial snipPROCEDURE

Office hysteroscopy with endometrial snip

Also known as: Office hysteroscopy combined with endometrial snip
Office hysteroscopy and endometrial snip
Office hysteroscopyPROCEDURE

Office hysteroscopy

Also known as: Outpatient hysteroscopy
Office hyteroscopy

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old
  • at least one patent tube
  • unexplained infertility, anovulation, mild to moderate male factor infertility
  • previous failed IUI

You may not qualify if:

  • indicated for ICSI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Al-AINY hospital

Cairo, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 26344351DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Waleed El-khayat, M.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 26, 2012

First Posted

March 6, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

December 30, 2014

Record last verified: 2014-12

Locations

EG(1)