NCT01245309

Brief Summary

Scratching the linning of the womb before IVF cycle could increase the chances of having a baby after an IVF cycle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Dec 2010

Typical duration for early_phase_1

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

First Submitted

Initial submission to the registry

November 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2010

Completed
9 days until next milestone

Study Start

First participant enrolled

December 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 15, 2014

Status Verified

January 1, 2014

Enrollment Period

3 years

First QC Date

November 19, 2010

Last Update Submit

January 14, 2014

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • live birth rate per woman

    9 months

Secondary Outcomes (1)

  • ongoing pregnancy rate

    12 weeks

Study Arms (2)

scratching

EXPERIMENTAL

endometrial scratching prior ivf cycle

Procedure: scratchingProcedure: A PLACEBO PROCEDURE

PLACEBO

PLACEBO COMPARATOR

PLACEBO PROCEDURE

Procedure: A PLACEBO PROCEDURE

Interventions

scratchingPROCEDURE

endometrial scratching before COH in IVF

scratching
A PLACEBO PROCEDUREPROCEDURE

A PLACEBO PROCEDURE

PLACEBOscratching

Eligibility Criteria

AgeUp to 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • WOMEN WITH PREVIOUS IVF FAILURE UNDERGOING IVF TREATMENT

You may not qualify if:

  • WOMEN\>40 YEARS OLD WOMEN UNDERGOING THEIR FIRST IVF TREATMENT CYCLE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, 53111, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

November 19, 2010

First Posted

November 22, 2010

Study Start

December 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 15, 2014

Record last verified: 2014-01

Locations

EG(1)