Endometrial Local Injury and Implantation Failure | NCT00837733

Studies
Endometrial Local Injury and Implantation Failure

NCT00837733

Sponsor

Yazd Research & Clinical Center for Infertility

Status

Completed

Last Update Posted

Feb 5, 2009Estimated

Enrollment

115Actual

Phase

Not Applicable

Conditions

Infertility

Interventions

Endometrial biopsy
Endometrial Biopsy

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Nov 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Feb 4, 2009

First Submission Date that Met QC Criteria

Feb 4, 2009

First Posted Date

Feb 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2009

Last Update Posted Date

Feb 5, 2009Estimated

Name	Class
Yazd Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the influence of endometrial biopsy on increasing implantation rate in patients with recurrent implantation failures, 93 women with at least two implantation failures were evaluated. In case group endometrial biopsy was obtained from 48 patients in the luteal phase of previous cycle and implantation and clinical pregnancy rate were compared with 45 patients in control group. The results suggest that in vitro fertilization or intracytoplasmic sperm injection after endometrial biopsy increase pregnancy outcome.

Detailed Description

In a randomized control trial study, 93 women with at least two implantation failures were evaluated. In case group endometrial biopsy was obtained from 48 patients in the luteal phase of previous cycle and implantation and clinical pregnancy rate were compared with 45 patients in control group.

The implantation rate was determined as 10.9% in biopsy group compared with 3.38% in controls. Clinical pregnancy rate was significantly higher in case group than controls (27.1% and 8.9% respectively

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

115Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biopsy catheter	Experimental	Biopsy catheter (Pipelle de Cornier, Prodimed, Neuilly-en-Thelle, France	Procedure: Endometrial biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endometrial biopsy	Procedure	Endometrial biopsy was done at luteal phase on the day 21-26 of spontaneous menstrual cycles, when GnRH agonist uses begun. Endometrial samples were taken by a biopsy catheter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Implantation Rate,Chemical pregnancy rate, Clinical pregnancy rate		One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

women with recurrent implantation failure which was defined as 2-6 cycles unsuccessful of IVF-ET in which more than 10 high grade embryo were transferred

Exclusion Criteria:

age over than 40 years old
poor responders to ovarian stimulation

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

39 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mohammad Ali Karimzadeh, Professor	Research and Clinical Center for Infertility	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research and Clinical Center for Infertility		Yazd	Yazd Province	8916877391	Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34110001	Derived	Lensen SF, Armstrong S, Gibreel A, Nastri CO, Raine-Fenning N, Martins WP. Endometrial injury in women undergoing in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Jun 10;6(6):CD009517. doi: 10.1002/14651858.CD009517.pub4.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases