NCT01636505

Brief Summary

The aim of this study is to performed a randomized controlled trial to evaluate the rate of genetic and chromosomal abnormalities in embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocols. Patients will be prospectively randomized in two groups: the first undergoing controlled ovarian stimulation in GnRH-agonist long protocol and the second following GnRH-antagonist ovarian stimulation regimen. The end-points of the study include the number of genetically and chromosomally abnormal embryos, the pregnancy, the implantation and the healthy baby birth rate. The patients included in PGS program were selected on the base of advanced maternal age, repeated pregnancy lost and implantation failure whereas the patients who were know to carry sex-linked or monogenic disorders were considered for PGD strategy. The uterine abnormalities, endometriosis and endocrinal diseases were considered to be the exclusion factors.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

July 10, 2012

Status Verified

July 1, 2012

Enrollment Period

5 months

First QC Date

July 5, 2012

Last Update Submit

July 9, 2012

Conditions

Embryo's Genetic and Chromosomal Quality

Outcome Measures

Primary Outcomes (1)

  • The results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocol

    difference in embryos' genetic and chromosomal quality using two different ovarian stimulation protocol

    one year

Study Arms (2)

short protocol

ACTIVE COMPARATOR

gnrh agonist versus gnrh antagonist

Drug: ghrh antagonist (cetrotide/orgalutran)

long protocol

ACTIVE COMPARATOR
Drug: gnrh agonist (suprefact)

Interventions

ghrh antagonist (cetrotide/orgalutran)DRUG

cetrotide/orgalutran 0.25 mg

short protocol
gnrh agonist (suprefact)DRUG

suprefact 5.5 ml

long protocol

Eligibility Criteria

Age18 Years - 46 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients carrier genetic disease
  • advanced maternal Age
  • repeated IVF failure
  • recurrent pregnancy loss

You may not qualify if:

  • uterine abnormalities
  • endometriosis
  • endocrinal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Hospital

Rome, 00148, Italy

Location

MeSH Terms

Interventions

cetrorelixganirelixGonadotropin-Releasing HormoneBuserelin

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2012

First Posted

July 10, 2012

Study Start

September 1, 2012

Primary Completion

February 1, 2013

Study Completion

September 1, 2013

Last Updated

July 10, 2012

Record last verified: 2012-07

Locations

IT(1)