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

This study has been completed.
Sponsor:
Collaborator:
IVI Madrid
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT00848185
First received: February 19, 2009
Last updated: September 16, 2009
Last verified: September 2009

February 19, 2009
September 16, 2009
June 2008
February 2009   (final data collection date for primary outcome measure)
well Levels of VEGF, sVE-Cadherin an Angiopietin 2 were determined by ELISA in serum and in follicular fluid. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00848185 on ClinicalTrials.gov Archive Site
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Differential Regulation of VEGF, Cadherin, Angiopietin 2 by Trigger Oocyte Maturation With GnRHa vs hCG in Donors
Differential Regulation of VEGF, Cadherin and Angiopietin 2 by Trigger Oocyte Maturation With GnRHa vs hCG in Donors: Try to Explain the Lower OHSS Incidence

Introduction OHSS still remains a complication of assisted reproduction treatments. hCG administration to trigger final oocyte maturation will release vascular mediators, being VEGF and other proteins such as VE-Cadherin or Angiopoietin- 2. It has been shown that replacing hCG by GnRH agonists will induce a very short endogenous LH peak, potent enough to induce final oocyte maturation but no OHSS will develop. The investigators examined VEGF, VE-Cadherin and Angiopoietin-2 modulation by hCG as well as GnRH agonists in oocyte donors undergoing controlled ovarian stimulation.

Material and Methods Between June and December of 2008 we evaluated 90 egg donors. They underwent COH with 150 IU rFSH as starting dose, we separated them in 3 groups (n:30 each): Groups 1 and 2 received a 0.25mg daily dose of GnRH antagonist when a follicle 14mm in diameter was observed. hCG 250g was given to group 1 while group 2 received triptorelin 0.2mg when leading two follicles were 17mm. Group 3 was stimulated with standard long protocol, hCG was given following similar criteria.

Blood was collected the day of hCG/aGnRH administration as well as the day of egg retrieval, and follicular fluid from the first two mature follicles was also frozen. We collected granulosa cells (GC) of 10 patients of each group as well Levels of VEGF, sVE-Cadherin an Angiopietin 2 were determined by ELISA in serum and in follicular fluid.

Results were analyzed via ANOVA.Data are expressed as mean± SEM. A significant difference was defined as p< 0.05.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

follicular fluid

Non-Probability Sample

oocyte Donors

Messurement Levels of VEGF
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  • Group1
    Protocol with antagonist and hCG to trigger oocyte maturation
  • Group 2
    Protocol with antagonist and 0,2 mg triptorelin to trigger oocyte maturation
  • Group 3
    Long Protocol and hCG to trigger oocyte maturation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Donors

Exclusion Criteria:

  • Important diseases
Female
18 Years to 34 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00848185
IVIMAD-MC-10-2008-01
Yes
MCerrillo, IVI Madrid
Instituto Valenciano de Infertilidad, Spain
IVI Madrid
Not Provided
Instituto Valenciano de Infertilidad, Spain
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP