Effect of Endometrial Biopsy in Assisted Reproduction Cycles Outcomes
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Effect of Local Injury to the Endometrium on Endometrial Receptivity in Assisted Reproduction Cycles|
- Pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Implantation rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||June 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
|Experimental: Endometrial biopsy||
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)
|Sham Comparator: No biopsy||
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.