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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00848185
Enrollment
96
Registered
2009-02-20
Start date
2008-06-30
Completion date
2009-03-31
Last updated
2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Endothelial Growth Factor Overexpression

Keywords

VEGF, Trigger, OHSS

Brief 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.

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.

Interventions

None listed

Sponsors

IVI Madrid
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 34 Years
Healthy volunteers
Yes

Inclusion criteria

* Donors

Exclusion criteria

* Important diseases

Design outcomes

Primary

MeasureTime frameDescription
VEGF Protein and mRNA Levels1 yearVEGF concentration in follicular fluid and VEGF mRNA expression in granulosa cells from patients who received either GnRH agonist instead of hCG

Participant flow

Participants by arm

ArmCount
Antagonist-hCG to Trigger
Protocol with antagonist and hCG to trigger oocyte maturation
32
Antagonist-aGnRH to Trigger
Protocol with antagonist and 0.2 mg triptorelin to trigger oocyte maturation
32
Long Protocol-hCG
Long Protocol and hCG to trigger oocyte maturation
32
Total96

Baseline characteristics

CharacteristicAntagonist-aGnRH to TriggerLong Protocol-hCGAntagonist-hCG to TriggerTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
32 Participants32 Participants32 Participants96 Participants
Age, Continuous23.7 years
STANDARD_DEVIATION 3.9
24.5 years
STANDARD_DEVIATION 3.7
27.2 years
STANDARD_DEVIATION 3.5
25.1 years
STANDARD_DEVIATION 3.7
Region of Enrollment
Spain
32 participants32 participants32 participants96 participants
Sex: Female, Male
Female
32 Participants32 Participants32 Participants96 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 320 / 320 / 32
serious
Total, serious adverse events
0 / 320 / 320 / 32

Outcome results

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

Time frame: 1 year

ArmMeasureValue (MEAN)Dispersion
Antagonist-hCG Levels of VEGFVEGF Protein and mRNA Levels1395 pg/mlStandard Deviation 284
Antagonist-aGnRH Levels of VEGFVEGF Protein and mRNA Levels1069 pg/mlStandard Deviation 354
Long Protocol- hCGVEGF Protein and mRNA Levels1666 pg/mlStandard Deviation 55
Comparison: ANOVA for three groupsp-value: <0.001ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026