NCT00848185

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2008

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2009

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
8.1 years until next milestone

Results Posted

Study results publicly available

April 17, 2017

Completed
Last Updated

June 26, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

February 19, 2009

Results QC Date

February 25, 2016

Last Update Submit

April 3, 2018

Conditions

Vascular Endothelial Growth Factor Overexpression

Keywords

VEGFTriggerOHSS

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

oocyte Donors

You may qualify if:

  • Donors

You may not qualify if:

  • Important diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

follicular fluid

Results Point of Contact

Title
Dra Cerrillo
Organization
IVI Madrid
maria.cerrillo@ivi.es
911802900

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

February 19, 2009

First Posted

February 20, 2009

Study Start

June 1, 2008

Primary Completion

February 1, 2009

Study Completion

March 1, 2009

Last Updated

June 26, 2018

Results First Posted

April 17, 2017

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share