NCT01571076

Brief Summary

Preimplantation Genetic Screening (PGS) is used for the selection of chromosomally normal embryos before the transfer in IVF treatments in many cases. There is great debate in the scientific community as to whether this is an efficient practice in patients of different prognosis. This prospective and randomized study seeks to study the results of chromosomal diagnosis using the new Comparative Genomic hybridization (CGH) arrays technique by practicing Preimplantation Genetic Screening (PGS) in day three biopsy on one arm of the study and not on the other arm in order to compare the results. The investigators will study the ongoing pregnancy rate of each oocyte retrieval and the ongoing implantation rate with Day 5 embryos (blastocysts) in IVF/ intracytoplasmic sperm injection (ICSI) treatments of embryos from two different groups of patients: Advanced Age Female Patients (38 - 41 years of age) and Male severe factor (≥2 million spermatozoids/ml.).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

January 19, 2021

Status Verified

April 1, 2019

Enrollment Period

2.6 years

First QC Date

March 29, 2012

Last Update Submit

January 14, 2021

Conditions

Embryo AneuploidiesImplantation RatesInfertility

Keywords

PGSCGHAneuploidyAdvanced maternal ageMale factor

Outcome Measures

Primary Outcomes (1)

  • Ongoing Implantation and Pregnancy Rate

    9 months

Study Arms (4)

Group B - Severe Male Factor

EXPERIMENTAL

PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst)

Other: Prolonged culture

Group B - Advanced Age

EXPERIMENTAL

PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst)

Other: Prolonged culture

Group A - Advanced Age

ACTIVE COMPARATOR

Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Advanced Age group

Genetic: PGS

Group A - Severe Male Factor

ACTIVE COMPARATOR

Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Severe Male Factor group.

Genetic: PGS

Interventions

PGSGENETIC

Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.

Group A - Severe Male Factor
Prolonged cultureOTHER

The embryos will be in prolonged culture and on going embryos transferred on Day 5 .

Group B - Advanced Age

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Women's Age: 38- 41 years old (both included)
  • Men's Age: 18-60 years old (both included)
  • Ovulation triggered with human chorionic gonadotrophin (hCG) (Ovitrelle, Merck-Serono, Madrid)
  • Number of Oocytes metaphase II (MII): ≥ 5 (fresh, not vitrified)
  • Quality of semen: ≥ 5 millions spermatozoids/ml

You may not qualify if:

  • Number of Oocytes metaphase II (MII): \<5 oocytes
  • Number of Oocytes obtained: \>20
  • Estradiol on the day of human chorionic gonadotrophin (hCG) \>3000 pgr/ml administration.
  • Progesterone on the day of hCG \>1,5 pmol/l administration
  • ≥ 2 previous miscarriages:biochemical,clinical,ectopic or a combination)
  • Any un corrected alteration in a previous study.
  • Other indications of (Preimplantation Genetic Diagnosis.Screening) PGD-S, such as monogenic illnesses, translocations, repeated implantation failure, repeated miscarriages, etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPAIN: IVI Valencia, IVI Barcelona, IVI Madrid

Valencia, 46015, Spain

Location

Related Publications (1)

  • Dahdouh EM, Balayla J, Garcia-Velasco JA. Impact of blastocyst biopsy and comprehensive chromosome screening technology on preimplantation genetic screening: a systematic review of randomized controlled trials. Reprod Biomed Online. 2015 Mar;30(3):281-9. doi: 10.1016/j.rbmo.2014.11.015. Epub 2014 Dec 11.

    PMID: 25599824DERIVED

MeSH Terms

Conditions

InfertilityAneuploidy

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesChromosome AberrationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Carlos Simon, MDPhD

    Director

    PRINCIPAL INVESTIGATOR

  • Carmen Rubio, PhD

    Igenomix

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Clinical Research IVI Valencia

Study Record Dates

First Submitted

March 29, 2012

First Posted

April 4, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2014

Study Completion

February 1, 2015

Last Updated

January 19, 2021

Record last verified: 2019-04

Locations

ES(1)