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Differential Regulation of VEGF, Cadherin, Angiopietin 2 by Trigger Oocyte Maturation With GnRHa vs hCG in Donors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00848185
First Posted: February 20, 2009
Last Update Posted: April 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Juan A Garcia-Velasco, IVI Madrid
Results First Submitted: February 25, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Vascular Endothelial Growth Factor Overexpression

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Antagonist Trigger With aGnRH Protocol with antagonist and 0,2 mg triptorelin to trigger oocyte maturation
Antagonist Trigger With hCG Protocol with antagonist and hCG to trigger oocyte maturation
Long Protocol hCG Long Protocol with hCG to trigger oocyte maturation

Participant Flow:   Overall Study
    Antagonist Trigger With aGnRH   Antagonist Trigger With hCG   Long Protocol hCG
STARTED   32   32   32 
COMPLETED   32   32   32 
NOT COMPLETED   0   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.
  • Age between 18 and 35 years and previous pregnancy
  • Regular menstrual cycles (between 25 and 35 days)
  • Normal karyotype
  • Body massindex between 18 and 25 kg/m2
  • Negative serology for VHB, VHC and HIV
  • Normal cervical cytology in the past year, and a vaginal ultrasound without evidence of any pathologic conditions

Reporting Groups
  Description
Antagonist-hCG to Trigger Protocol with antagonist and hCG to trigger oocyte maturation
Antagonist-aGnRH to Trigger Protocol with antagonist and 0.2 mg triptorelin to trigger oocyte maturation
Long Protocol-hCG Long Protocol and hCG to trigger oocyte maturation
Total Total of all reporting groups

Baseline Measures
   Antagonist-hCG to Trigger   Antagonist-aGnRH to Trigger   Long Protocol-hCG   Total 
Overall Participants Analyzed 
[Units: Participants]
 32   32   32   96 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      32 100.0%      32 100.0%      32 100.0%      96 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.2  (3.5)   23.7  (3.9)   24.5  (3.7)   25.1  (3.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      32 100.0%      32 100.0%      32 100.0%      96 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment [1] 
[Units: Participants]
       
Spain   32   32   32   96 
[1] The donors were recruit for the clinic


  Outcome Measures

1.  Primary:   VEGF Protein and mRNA Levels   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


Results Point of Contact:  
Name/Title: Dra Cerrillo
Organization: IVI Madrid
phone: 911802900
e-mail: maria.cerrillo@ivi.es



Responsible Party: Juan A Garcia-Velasco, IVI Madrid
ClinicalTrials.gov Identifier: NCT00848185     History of Changes
Other Study ID Numbers: IVIMAD-MC-10-2008-01
First Submitted: February 19, 2009
First Posted: February 20, 2009
Results First Submitted: February 25, 2016
Results First Posted: April 17, 2017
Last Update Posted: April 17, 2017