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Endometrial Injury for Assisted Reproduction

NCT01132144 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2014-02-17

Study results available
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Summary

The objective of this study is to evaluate the effect of endometrial injury performed prior ovulation induction for assisted reproductive techniques main outcomes.

Conditions

Interventions

PROCEDURE

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.

PROCEDURE

Control group

The investigator will dry the cervix with gauze and forceps for for 30 seconds or until participant ask for stopping.

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

  • Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

    collaborator OTHER

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

    collaborator OTHER_GOV

Principal Investigators

  • Wellington P Martins, PhD · Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01132144 on ClinicalTrials.gov