Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
158 participants
INTERVENTIONAL
2010-06-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Endometrial injury group
Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation.
Endometrial injury
Evaluate the position and size of the uterus by transabdominal ultrasonography, with the bladder comfortably full.
Identify the cervix with a disposable speculum. Open one sealed opaque envelope for allocation.
Endometrial injury:
* Slide the Pipelle de Cornier® (Laboratoires Prodimed, Neully-En-Thelle, France) gently through the cervix up to the uterine fundus. Transbadominal ultrasound might be used to confirm position.
* Draw back the piston to the end of the biopsy cannula until it locks creating a negative pressure.
* Sweep the uterine fundus slowly several times up to the internal orifice of the cervix, using regular to-and-fro movements while rotating the sampler to include the whole uterine cavity in the specimen, for 30 seconds or until participant ask for stopping.
Control group
Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
Control group
The investigator will dry the cervix with gauze and forceps for for 30 seconds or until participant ask for stopping.
Interventions
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Endometrial injury
Evaluate the position and size of the uterus by transabdominal ultrasonography, with the bladder comfortably full.
Identify the cervix with a disposable speculum. Open one sealed opaque envelope for allocation.
Endometrial injury:
* Slide the Pipelle de Cornier® (Laboratoires Prodimed, Neully-En-Thelle, France) gently through the cervix up to the uterine fundus. Transbadominal ultrasound might be used to confirm position.
* Draw back the piston to the end of the biopsy cannula until it locks creating a negative pressure.
* Sweep the uterine fundus slowly several times up to the internal orifice of the cervix, using regular to-and-fro movements while rotating the sampler to include the whole uterine cavity in the specimen, for 30 seconds or until participant ask for stopping.
Control group
The investigator will dry the cervix with gauze and forceps for for 30 seconds or until participant ask for stopping.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 38 years.
* Written informed consent.
Exclusion Criteria
18 Years
38 Years
FEMALE
No
Sponsors
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Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
OTHER
Conselho Nacional de Desenvolvimento Científico e Tecnológico
OTHER_GOV
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
OTHER_GOV
University of Sao Paulo
OTHER
Responsible Party
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Wellington P Martins, MD
PhD
Principal Investigators
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Wellington P Martins, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo
Locations
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Setor de Reproducao Humana do HC-FMRP-USP
Ribeirão Preto, São Paulo, Brazil
Countries
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References
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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.
Other Identifiers
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HCRP10340/09
Identifier Type: -
Identifier Source: org_study_id
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