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, IVI VALENCIA
ClinicalTrials.gov Identifier:
NCT00848185
First received: February 19, 2009
Last updated: September 16, 2009
Last verified: September 2009
  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
Messurement Levels of VEGF

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 Instituto Valenciano de Infertilidad, IVI VALENCIA:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

follicular fluid


Enrollment: 60
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
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

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

Ages Eligible for Study:   18 Years to 34 Years
Genders 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
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: MCerrillo, IVI Madrid
ClinicalTrials.gov Identifier: NCT00848185     History of Changes
Other Study ID Numbers: IVIMAD-MC-10-2008-01
Study First Received: February 19, 2009
Last Updated: September 16, 2009
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Instituto Valenciano de Infertilidad, IVI VALENCIA:
VEGF
Trigger
OHSS

ClinicalTrials.gov processed this record on August 26, 2014