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

Vascular Endothelial Growth Factor Overexpression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848185
• Other study ID #: IVIMAD-MC-10-2008-01
• Status: Completed
• Start date: June 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2018
• Source: IVI Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

Inclusion Criteria:

• Donors

Exclusion Criteria:

• Important diseases

Related Conditions & MeSH terms

• Vascular Endothelial Growth Factor Overexpression

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IVI Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VEGF Protein and mRNA Levels	VEGF concentration in follicular fluid and VEGF mRNA expression in granulosa cells from patients who received either GnRH agonist instead of hCG	1 year