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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
  Purpose
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.

Condition
Vascular Endothelial Growth Factor Overexpression

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Further study details as provided by Juan A Garcia-Velasco, IVI Madrid:

Primary Outcome Measures:
  • VEGF Protein and mRNA Levels [ Time Frame: 1 year ]
    VEGF concentration in follicular fluid and VEGF mRNA expression in granulosa cells from patients who received either GnRH agonist instead of hCG


Biospecimen Retention:   Samples With DNA
follicular fluid

Enrollment: 96
Study Start Date: June 2008
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Antagonist-hCG for triggering
Protocol with antagonist and hCG to trigger oocyte maturation
Antagonist-aGnRH for triggering
Protocol with antagonist and 0,2 mg triptorelin to trigger oocyte maturation
Long protocol-hCG for triggering
Long Protocol and hCG to trigger oocyte maturation

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 34 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
oocyte Donors
Criteria

Inclusion Criteria:

  • Donors

Exclusion Criteria:

  • Important diseases
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Juan A Garcia-Velasco, MD PhD, 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
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Juan A Garcia-Velasco, IVI Madrid:
VEGF
Trigger
OHSS