Preimplantation Genetic Screening (PGS) in Advanced Female Age and Male Severe Factor

January 14, 2021 updated by: Carlos Simon, Igenomix

Prospective and Randomized Study of the Use of Comparative Genomic Hybridization (CGH) Arrays to Study Embryo Aneuploidies in Female Advanced Age and Male Factor In Vitro Fertilization (IVF) Patients.

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.).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The randomized controlled trial results of advanced maternal age was completed and published (Rubio et al., Fertility&Sterility 2017).

The randomized controlled trial results of the male factor indication was terminated with anticipation due to the change of the technology that prevented recruitment of patients using the old technology (that one used in the study).

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46015
        • SPAIN: IVI Valencia, IVI Barcelona, IVI Madrid

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: ADVANCED AGE and SEVERE MALE FACTOR:

  • 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

Exclusion Criteria: ADVANCED AGE and SEVERE MALE FACTOR:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group B - Severe Male Factor
PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst)
Other: Prolonged culture
The embryos will be in prolonged culture and on going embryos transferred on Day 5 .
Other: Prolonged culture
Prolonged culture of the embryos and posterior transfer of ongoing Day 5 blastocysts.
EXPERIMENTAL: Group B - Advanced Age
PGS of day three biopsies and consequent embryo transfer on on Day 5 (blastocyst)
Other: Prolonged culture
The embryos will be in prolonged culture and on going embryos transferred on Day 5 .
Other: Prolonged culture
Prolonged culture of the embryos and posterior transfer of ongoing Day 5 blastocysts.
ACTIVE_COMPARATOR: Group A - Advanced Age
Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Advanced Age group
Genetic: PGS
Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.
ACTIVE_COMPARATOR: Group A - Severe Male Factor
Prolonged culture, no PGS, for Day 5 (blastocyst) embryo transfer for the Severe Male Factor group.
Genetic: PGS
Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ongoing Implantation and Pregnancy Rate
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Igenomix

Investigators

  • Principal Investigator: Carlos Simon, MDPhD, Director
  • Study Chair: Carmen Rubio, PhD, Igenomix

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2012

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

February 1, 2015

Study Registration Dates

First Submitted

March 29, 2012

First Submitted That Met QC Criteria

April 2, 2012

First Posted (ESTIMATE)

April 4, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 19, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1112-C-091-CR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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