Endometrial Injury for Assisted Reproduction

This study has been terminated.
(Stopped after safety analysis because of significant benefit of intervention.)
Sponsor:
Collaborators:
FAEPA
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Wellington P Martins, MD, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01132144
First received: May 26, 2010
Last updated: January 2, 2014
Last verified: January 2014
Results First Received: June 18, 2013  
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
Condition: Infertility
Interventions: Procedure: Endometrial injury
Procedure: Control group

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The recruitment occurred from July 2010 to March 2012 in the fertility clinic of an university hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All women that fulfilled eligibility criteria were invited to participate. Those who agreed were included. No women was excluded.

Reporting Groups
  Description
Endometrial Injury Group Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
Control Group Introduction of the speculum and wiping of the cervix with gaze for 30 seconds

Participant Flow:   Overall Study
    Endometrial Injury Group     Control Group  
STARTED     79     79  
COMPLETED     79     79  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Endometrial Injury Group Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
Control Group Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
Total Total of all reporting groups

Baseline Measures
    Endometrial Injury Group     Control Group     Total  
Number of Participants  
[units: participants]
  79     79     158  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     79     79     158  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  32.4  ± 3.2     32.1  ± 3.1     32.2  ± 3.2  
Gender  
[units: participants]
     
Female     79     79     158  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Brazil     79     79     158  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Live Birth   [ Time Frame: 1 year ]

2.  Secondary:   Clinical Pregnancy   [ Time Frame: 3 months ]

3.  Secondary:   Ongoing Pregnancy   [ Time Frame: 6 months ]

4.  Secondary:   Miscarriage   [ Time Frame: 9 months ]

5.  Secondary:   Endometrial Thickness   [ Time Frame: 1 month ]

6.  Secondary:   Endometrial Volume   [ Time Frame: 1 month ]

7.  Secondary:   Three-dimensional Doppler Indices From Endometrium (VFI)   [ Time Frame: 1 month ]

8.  Secondary:   Procedure Related Pain   [ Time Frame: Immediately after procedure ]

9.  Secondary:   Implantation Rate   [ Time Frame: 3 months ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Wellington P Martins
Organization: University of Sao Paulo
phone: 55162231
e-mail: wpmartins@gmail.com


No publications provided


Responsible Party: Wellington P Martins, MD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01132144     History of Changes
Other Study ID Numbers: HCRP10340/09
Study First Received: May 26, 2010
Results First Received: June 18, 2013
Last Updated: January 2, 2014
Health Authority: Brazil: Ethics Committee