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
Recruitment status was Not yet recruiting
Sponsor:
University of Sao Paulo
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Infertility |
Procedure: Endometrial biopsy Other: Speculum examination |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by University of Sao Paulo:
Primary Outcome Measures:
- Pregnancy rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Implantation rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 405 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Ages Eligible for Study: | 18 Years to 38 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Wellington de Paula Martins - Responsable researcher, Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo |
| ClinicalTrials.gov Identifier: | NCT01132144 History of Changes |
| Other Study ID Numbers: | HCRP10340/09 |
| Study First Received: | May 26, 2010 |
| Last Updated: | June 14, 2010 |
| Health Authority: | Brazil: Institutional Review Board |
Keywords provided by University of Sao Paulo:
|
Reproductive Techniques Embryo Implantation Endometrium Ultrasonography |
Additional relevant MeSH terms:
|
Infertility Adenoma Genital Diseases, Male Genital Diseases, Female |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
ClinicalTrials.gov processed this record on June 18, 2013