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NCT Number: NCT01571076

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

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.).

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Key information

Conditions

Embryo Aneuploidies Aneuploidy Chromosome Aberrations Genital Diseases Implantation Rates Infertility Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SPAIN: IVI Valencia, IVI Barcelona, IVI Madrid

Valencia, 46015, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PGS

Genetic

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

Prolonged culture

Other

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

Primary outcomes

  1. Ongoing Implantation and Pregnancy Rate

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Igenomix

Industry

Registry information

Official study title

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.

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 4, 2012
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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