Endometrial Scratching Prior to Controlled Ovarian Stimulation (COH) in Women Undergoing In-vitro Fertilization With Previous IVF Failure

NCT ID: NCT01245309

Last Updated: 2014-01-15

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

EARLY_PHASE1

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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All women with history of RIF (as defined by ESHRE) and who wish to undertake another assisted conception treatment cycle are invited to participate in the trial. Women will be randomised to two arms; one undergoing endometrial sampling and control. Women in the experimental arm will be subjected to endometrial scrapping with Pipelle biopsy catheter two times; on days 21 and 26 of the cycle prior to the IVF index cycle and after initiation of the GnRHa in the long agonist protocol. Women in the control group will undergo a placebo procedure using the uterine sound on the same days of the cycle like women in the intervention group.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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scratching

endometrial scratching prior ivf cycle

Group Type EXPERIMENTAL

scratching

Intervention Type PROCEDURE

endometrial scratching before COH in IVF

A PLACEBO PROCEDURE

Intervention Type PROCEDURE

A PLACEBO PROCEDURE

PLACEBO

PLACEBO PROCEDURE

Group Type PLACEBO_COMPARATOR

A PLACEBO PROCEDURE

Intervention Type PROCEDURE

A PLACEBO PROCEDURE

Interventions

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scratching

endometrial scratching before COH in IVF

Intervention Type PROCEDURE

A PLACEBO PROCEDURE

A PLACEBO PROCEDURE

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

WOMEN WITH PREVIOUS IVF FAILURE UNDERGOING IVF TREATMENT

\-

Exclusion Criteria

* WOMEN\>40 YEARS OLD WOMEN UNDERGOING THEIR FIRST IVF TREATMENT CYCLE
Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Gibreel

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura University

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AG1001

Identifier Type: -

Identifier Source: org_study_id

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