Effect of Endometrial Biopsy in Assisted Reproduction Cycles Outcomes

The recruitment status of this study is unknown because the information has not been verified recently.

Verified May 2010 by University of Sao Paulo.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

University of Sao Paulo

ClinicalTrials.gov Identifier:

NCT01132144

First received: May 26, 2010

Last updated: June 14, 2010

Last verified: May 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	May 26, 2010
Last Updated Date	June 14, 2010
Start Date ^ICMJE	June 2010
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 26, 2010)	Pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: No ] Implantation rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01132144 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 26, 2010)	Endometrial volume change [ Time Frame: 1 year ] [ Designated as safety issue: No ] Three-dimensional sonographic measurement of endometrial volume on the day of hCG indication (in the embryo transfer cycle) minus the endometrial volume on the day of the biopsy (in the previous cycle). Three-dimensional Doppler indices changes of the sub-endometrium [ Time Frame: 1 year ] [ Designated as safety issue: No ] The change in three-dimensional Doppler indices on the day of hCG indication (in the embryo transfer cycle) minus these indices on the day of the endometrial biopsy (in the previous cycle). Multiple pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ] Abortion rates [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Endometrial Biopsy in Assisted Reproduction Cycles Outcomes
Official Title ^ICMJE	Effect of Local Injury to the Endometrium on Endometrial Receptivity in Assisted Reproduction Cycles
Brief Summary	The objective of this study is to compare the rates of implantation and pregnancy, and change in sonographic measurements of endometrial volume and vascularization in patients undergoing assisted reproduction cycles randomly assigned to the traditional treatment without previous manipulation of the endometrium and to the traditional treatment plus an endometrial biopsy in cycle prior to embryo transfer.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Infertility
Intervention ^ICMJE	Procedure: Endometrial biopsy One endometrial biopsy performed with a disposable Pipelle de Cornier between days 14 and 21 of the cycle previous to the embryo transfer one. Other Name: Pipelle de Cornier (Sepal Reproductive Devices) Other: Speculum examination A regular speculum examination will be performed on one day between day 14 and 21 of he cycle previous to the embryo transfer one.
Study Arm (s)	Experimental: Endometrial biopsy Intervention: Procedure: Endometrial biopsy Sham Comparator: No biopsy Intervention: Other: Speculum examination
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	405
Estimated Completion Date	June 2012
Estimated Primary Completion Date	June 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Women who will start treatment for infertility with high complexity assisted reproduction procedures. Age between 18 and 38 years. Written informed consent to participate in the research. Exclusion Criteria: Cycle canceling for any reason. Uterine pathologies such as nodules (fibromas, polyps). Technical inability to perform the endometrial biopsy.
Gender	Female
Ages	18 Years to 38 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01132144
Other Study ID Numbers ^ICMJE	HCRP10340/09
Has Data Monitoring Committee	No
Responsible Party	Wellington de Paula Martins - Responsable researcher, Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Study Sponsor ^ICMJE	University of Sao Paulo
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Sao Paulo
Verification Date	May 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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