An observational study in Vascular Endothelial Growth Factor Overexpression, sponsored by IVI Madrid. Completed. Open to female participants aged 18 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-26.
Sponsored by IVI Madrid · Observational
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.
IVI Madrid is the lead sponsor of 35 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
oocyte Donors
Exclusion Criteria:
Protocol with antagonist and hCG to trigger oocyte maturation
Protocol with antagonist and 0,2 mg triptorelin to trigger oocyte maturation
Long Protocol and hCG to trigger oocyte maturation
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
| Milestone | Antagonist Trigger With aGnRH | Antagonist Trigger With hCG | Long Protocol hCG |
|---|---|---|---|
| Started | 32 | 32 | 32 |
| Completed | 32 | 32 | 32 |
| Not completed | 0 | 0 | 0 |
VEGF concentration in follicular fluid and VEGF mRNA expression in granulosa cells from patients who received either GnRH agonist instead of hCG
| pg/ml | Antagonist-hCG Levels of VEGF | Antagonist-aGnRH Levels of VEGF | Long Protocol- hCG |
|---|---|---|---|
| VEGF Protein and mRNA Levels | 1395 ± 284 | 1069 ± 354 | 1666 ± 55 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GnRH Antagonist - hCG Trigger | — | 0/32 (0%) | 0/32 (0%) |
| GnRH Antagonist Triptorelin Trigger | — | 0/32 (0%) | 0/32 (0%) |
| Long Protocol - hCG Trigger | — | 0/32 (0%) | 0/32 (0%) |
* Age between 18 and 35 years and previous pregnancy * Regular menstrual cycles (between 25 and 35 days) * Normal karyotype * Body massindex between 18 and 25 kg/m2 * Negative serology for VHB, VHC and HIV * Normal cervical cytology in the past year, and a vaginal ultrasound without evidence of any pathologic conditions
| Age, Categorical(Participants) | Antagonist-hCG to Trigger | Antagonist-aGnRH to Trigger | Long Protocol-hCG | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 32 | 32 | 32 | 96 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Antagonist-hCG to Trigger | Antagonist-aGnRH to Trigger | Long Protocol-hCG | Total |
|---|---|---|---|---|
| Mean | 27.2 ± 3.5 | 23.7 ± 3.9 | 24.5 ± 3.7 | 25.1 ± 3.7 |
| Sex: Female, Male(Participants) | Antagonist-hCG to Trigger | Antagonist-aGnRH to Trigger | Long Protocol-hCG | Total |
|---|---|---|---|---|
| Female | 32 | 32 | 32 | 96 |
| Male | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Antagonist-hCG to Trigger | Antagonist-aGnRH to Trigger | Long Protocol-hCG | Total |
|---|---|---|---|---|
| Spain | 32 | 32 | 32 | 96 |
No study locations are listed for this record.
Plan to share: No
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IVI Madrid